StemCell Therapy

HACKENSACK, N.J., Feb. 18, 2021 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a US nonprofit organization leading the fight to endDuchenne muscular dystrophy (Duchenne), andDuchenne UK, a UK-based patient organization,are pleased to announce ProfessorKanneboyina Nagaraju at Binghamton, the State University of New York, as the recipient of their Joint Research Grant Call of 2020. The full title of the research project is "Targeting the innate immune system to block acute inflammatory and chronic immune response to transgene and AAV vector in DMD".Professor Nagaraju's research will receive funding from the organizations in the amount of $350,000.

These are promising times for research into Duchenne muscular dystrophy (Duchenne). Several companies are now testing an approach that uses a shortened dystrophin gene to replace the faulty dystrophin gene in Duchenne. This is known as gene transfer using micro-dystrophin, or more commonly, gene therapy. The companies are using viruses known as AAVs (adeno-associated viruses) to deliver the therapy.

However, challenges exist in getting this treatment to the entire Duchenne population. This is mainly because of immune responses: some patients have pre-existing antibodies to the AAVs. This means they will not, currently, be able to have the treatment because their bodies will recognize the virus and stop it from delivering the micro-dystrophin to the cells. In addition, as gene therapy is a new treatment, it is not yet clear if another dose will be required at a later stage, and it is not currently possible to re-dose with the same AAV.

This is why Duchenne UK & PPMD launched a call for projects last year that would specifically address this challenge.

The organizations received a large number of proposals, and three were taken forward for final review from a panel of highly qualified, specialized scientists. They looked at a wide variety of factors, including significance to the Duchenne community, and the ability to translate the research into treatments for patients.

Professor Nagaraju's research is looking at blocking the mechanism by which the body is able to recognise an AAV virus and mount an immune response to it. Importantly, he is using medicines that are already in use in humans, in an approach known as repurposing.

If this approach were successful, it would allow more micro-dystrophin to get to the cells, potentially requiring a lower dose of the AAV than is currently being administered in the trials. It may also allow patients who have already been dosed with gene therapy to receive further doses. Further to this, by using repurposed drugs, this treatment should be more easily transferable to patients. Professor Nagaraju believes that "targeting initial immune recognition pathways is one way to improve efficacy and safety profiles of AAV mediated gene therapy".

PPMD's Founding President & CEO, Pat Furlong, and Duchenne UK's CEO, Emily Crossley explained in a joint statement:"Supporting patients and accelerating innovative research is at the heart of what we do at Duchenne UK and PPMD. We are pleased to partner with each other and award this grant. Gene therapy is offering great promise, but there are challenges associated with the immune response which are limiting the rate of progress and a barrier to ensuring all patients can have access to these potentially transformative therapies.We would like to thank all those who participated and supported our Joint Grant Call and are very much looking forward to working with Professor Nagaraju on this vitally important project for the Duchenne community."

To learn more about PPMD's innovative research agenda and our investment portfolio, visit PPMD's website.

About Parent Project Muscular Dystrophy

Duchenneis a fatal genetic disorder that slowly robs people of their muscle strength. Parent Project Muscular Dystrophy (PPMD) fights every single battle necessary to end Duchenne.

We demand optimal care standards and ensure every family has access to expert healthcare providers, cutting edge treatments, and a community of support. We invest deeply in treatments for this generation of Duchenne patients and in research that will benefit future generations. Our advocacy efforts have secured hundreds of millions of dollars in funding and won four FDA approvals.

Everything we doand everything we have done since our founding in 1994helps those with Duchenne live longer, stronger lives. We will not rest until we end Duchenne for every single person affected by the disease. Join our fight against Duchenne at EndDuchenne.org. Follow PPMD on Facebook, Twitter, Instagram, and YouTube.

About Duchenne UK

Duchenne Muscular Dystrophy (DMD) is a devastating muscle-wasting disease. It is the most common and severe form of Muscular Dystrophy. Diagnosed in childhood, it mainly affects boys. There is currently no cure. Started by families affected by the disease, Duchenne UK has one clear aim to end Duchenne.

Duchenne UK are funding research that's focused on getting treatments to those affected now as well as pushing for an effective treatment in the future.

Duchenne UK connects leading researchers with industry, the NHS and patients to challenge every stage of drug development, from research to clinical trials to drug approval. They connect families with each other to create a network of mutual support and to pool resources, knowledge and experience.

For more information about Duchenne UK: visit http://www.duchenneuk.org.

SOURCE Parent Project Muscular Dystrophy (PPMD)

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Duchenne UK and Parent Project Muscular Dystrophy Award $350,000 to Address Immunological Challenges of Gene Therapy in Duchenne Muscular Dystrophy -...

Dublin, Feb. 15, 2021 (GLOBE NEWSWIRE) -- The "Europe Cell and Gene Therapy Market - Industry Outlook and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.

In-depth Analysis and Data-driven Insights on the Impact of COVID-19 Included in this Europe Cell and Gene Therapy Market Report

The Europe cell and gene therapy market by revenue is expected to grow at a CAGR of over 23% during the period 2021-2026.

The global cell and gene therapy market is observing significant mergers and acquisition activities, product sales, and new market authorizations. In 2026, the market is expected to grow almost four times more than the current value, with new product approvals expected annually. Although initial product approvals have been for relatively small patient groups, the significant pipeline of cell & gene therapy studies for diseases such as hemophilia and various forms of blindness will significantly expand.

In addition, the Europe market is witnessing steady growth due to the increased availability of funds from several public and private institutes. There is increased support from regulatory bodies for product approvals and fast-track product designations, which encourage vendors to manufacture products at a fast rate. Moreover, with over 237 regenerative medicines companies headquartered in Europe, the region is seen as the favorite destination for cell and gene therapy manufacturing.

Europe Cell and Gene Therapy Market Segmentation

The Europe cell and gene therapy market research report includes a detailed segmentation by product, end-user, application, geography. A high potential to treat several chronic diseases, which cannot be effectively treated/cured through conventional methods otherwise, is propelling the growth of gene therapies. Gene therapies are regarded as a potential revolution in the health sciences and pharmaceutical fields.

The number of clinical trials investigating gene therapies is increasing in Europe, despite the limited number of products that have successfully reached the market. However, gene therapies show slow progress and promising prospect in terms of treatments. High support from regulatory bodies to commercialize these products and make them affordable to patients is another important factor contributing the market growth.

Delivering cell and gene therapies requires specialized facilities, capabilities, and clinician skills. Therefore, manufacturers are working in tandem with chosen treatment centers (hospitals) to establish the protocols and procedures necessary to receive the product and therapies. While cell therapies represent a paradigm shift in the treatment of several incurable, chronic diseases, with durable responses and long-term disease control measures, hospitals appear an ideal location to carry out these procedures.

Hospitals are growing at a significant rate due to the increasing target population in Europe. Tier-I hospitals are proving to be sought-after network partners for cell and gene therapy developers. They tend to be in major population centers, have adequate financial and personnel resources, and value the prestige that comes with being the first movers in an innovative treatment area.

Oncology accounted for a share of over 30% in 2020. While cancer treatments have evolved and undergone massive developments in recent years, it continues to be one of the deadliest diseases confronted by humans. Traditional cancer therapies have a curative effect in the short term; however, they have side effects, thereby decreasing the patient's quality of life. Cell and gene therapies for certain types of cancers have been promising results. The chimeric antigen receptor- (CAR-) T cell therapy is one of the most recent innovative immunotherapies and is rapidly evolving.

CAR-T cell therapies are developing rapidly, and many clinical trials have been established on a global scale, which has high commercial potential for the treatment of cancer. Immunotherapies based on CAR-T cells go one step further, engineering the T cells themselves to enhance the natural immune response against a specific tumor antigen. CAR-T clinical trials have shown high remission rates, up to 94%, in severe forms of blood cancer, thereby increasing the market growth.

INSIGHTS BY VENDORS

Novartis, Spark Therapeutics, Amgen, Gilead Sciences, and Organogenesis are the leading players in the Europe cell and gene therapy market. The market offers tremendous growth opportunities for existing and future/emerging players on account of the presence of a large pool of target patient population with chronic diseases such as cancer, wound disorders, diabetic foot ulcer, CVDs, and other genetic disorders. Recent approvals have prompted an unprecedented expansion among vendors. While a few vendors are opting for in-house production of cell and gene therapies, a substantial number of vendors are preferring third-party service providers, including CMOs.

KEY QUESTIONS ANSWERED

1. What is the Europe cell and gene therapy market size and growth rate during the forecast period?2. What are the factors driving the demand for CAR-T therapy in the European region?3. How are strategic acquisitions aiding in market growth of cell and gene therapy products?4. Which segments are expected to generate the highest revenues during the forecast period?5. Who are the leading vendors in the European cell and gene therapy market?

Market DynamicsMarket Opportunities & Trends

Market Growth Enablers

Market Restraints

Prominent Vendors

Other Prominent Vendors

Emerging Investigational Vendors In Europe

For more information about this report visit https://www.researchandmarkets.com/r/qm1hjg

Read more from the original source:
Europe Cell and Gene Therapy Market Report 2021-2026: Prominent Players are Novartis, Spark Therapeutics, Amgen, Gilead Sciences & Organogenesis -...

Betibeglogene autotemcel (beti-cel), a one-time gene therapy, enabled durable transfusion independence in most patients with transfusion-dependent -thalassemia (TDT) who were treated across 4 clinical studies.

Of 60 patients enrolled overall, 17 of 22 (77%) treated in the 2 phase 1/2 studies were able to stop packed red blood cell transfusions. In the 2 phase 3 studies, which used a refined manufacturing process resulting in improved beti-cel characteristics, 89% (n = 31/35) of patients with at least 6 months of follow-up achieved transfusion independence for more than 6 months,1 reported Suradej Hongeng, MD, during the virtual 2021 Transplantation & Cellular Therapy Meetings.

The median follow-up after beti-cel infusion in the 4 studies has been 24.8 months (range, 1.1-71.8).

With up to 6 years of follow-up, 1-time beti-cel gene therapy enabled durable transfusion independence in the majority of patients, said Hongeng, from Ramathibodi Hospital of Mahidol University, in Bangkok, Thailand.

Patients who achieved transfusion independence experienced a 38% median reduction in liver iron concentration (LIC) from baseline to month 48. The median reduction in LIC was 59% in patients with a baseline LIC more than 15 mg/g dw. A total of 21 of 37 (57%) patients who achieved transfusion independence have stopped iron chelation for 6 months or longer, with a median duration of 18.5 months from stopping iron chelation to last follow-up.

Erythropoiesis as determined by soluble transferrin receptor level was also improved in transfusion-independent patients. Bone marrow biopsies showed improvement in the myeloid:erythroid ratio.

Beti-cel adds functional copies of a modified form of the -globin (A-T87Q-globin) gene into a patients own hematopoietic stem cells (HSCs) through transduction of autologous CD34+ cells using a BB305 lentiviral vector. Following single-agent busulfan myeloablative conditioning, beti-cel is infused, after which the transduced HSCs engraft and reconstitute red blood cells containing functional adult hemoglobin derived from the gene therapy.

Of the 60 patients treated, 43 were genotype non-/ and 17 were / . The median age at consent was 20 years in the phase 1/2 trials and 15 years in the phase 3 trials. Median LIC at baseline was 7.1 and 5.5 mg Fe/g dw, respectively, and median cardiac T2 was 34 and 37 msec, respectively. The vector copy number was 0.8 in the phase 1/2 trial and 3.0 in the phase 3 study. Additionally, 32t and 78t CD34+ cells were transduced, respectively.

The phase 1/2 studies showed promising results but lower achievement of transfusion independence in patients with the / genotype, leading to a refinement in the manufacturing process, which resulted in a higher number of transduced cells and a higher number of vector copy number, said Hongeng.

The median time to neutrophil engraftment was 22.5 days and the median time to platelet engraftment was 44 days. Lymphocyte subsets were generally within the normal range after beti-cel infusion, which is different from allogeneic stem cell [transplantation], which is probably around 6 months to a year to get complete recovery of immune reconstitution, he said. The median duration of hospitalization was 42 days.

All patients were alive at the last follow-up (March 3, 2020). Eleven of 60 (18%) of patients experienced at least 1 adverse event (AE) considered related or possibly related to beti-cel, the most common being abdominal pain (8%) and thrombocytopenia (5%). Serious AEs were those expected after myeloablative conditioning: veno-occlusive liver disease (8%), neutropenia (5%), pyrexia (5%), thrombocytopenia (5%), and appendicitis, febrile neutropenia, major depression, and stomatitis (3% each).

Of the 7 patients experiencing veno-occlusive liver disease, 3 were of grade 4 and 2 were of grade 3. Two other patients had grade 2 veno-occlusive disease. There were no cases of insertional oncogenesis.

Persistent vector-positive hematopoietic cells and durable HbaT87Q levels supported stable total hemoglobin over time. In phase 3 trials, the median peripheral blood vector copy number was 1.2 c/dg at month 12 and 2.0 c/dg at month 24, and the median total hemoglobin was 11.5 g/dL at month 12 and 12.9 g/dL at month 24.

The weighted average of hemoglobin during transfusion independence in the phase 1/2 trials was 10.4 g/dL, and patients were transfusion-independent for a median of 51.2 months. In the phase 3 studies, the weighted average of hemoglobin during transfusion independence was 11.9 g/dL, and patients were transfusion-independent for a medium 17.7 months.

Hongeng S, Thompson AA, Kwiatkowski JL, et al. Efficacy and safety of betibeglogene autotemcel (beti-cel; LentiGlobin for -thalassemia) gene therapy in 60 patients with transfusion-dependent -thalassemia (TDT) followed for up to 6 years post-infusion. Presented at: 2021 Transplantation & Cellular Therapy Meetings; February 8-12, 2021; virtual. Abstract 1.

More:
Beti-Cel Gene Therapy Frees Patients With Beta-Thalassemia From Red Blood Cell Transfusions - OncLive

NEW YORK and RESEARCH TRIANGLE PARK, N.C., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically improve the lives of patients with neurodegenerative diseases, announced today that the company will present at the 10th Annual SVB Leerink Global Healthcare Conference taking place February 22-26, 2021. Details on the presentation can be found below.

Company management will also participate in one-on-one investor meetings at the conference.

About Sio Gene Therapies

Sio Gene Therapies combines cutting-edge science with bold imagination to develop genetic medicines that aim to radically improve the lives of patients. Our current pipeline of clinical-stage candidates includes the first potentially curative AAV-based gene therapies for GM1 gangliosidosis and Tay-Sachs/Sandhoff diseases, which are rare and uniformly fatal pediatric conditions caused by single gene deficiencies. We are also expanding the reach of gene therapy to highly prevalent conditions such as Parkinsons disease, which affects millions of patients globally. Led by an experienced team of gene therapy development experts, and supported by collaborations with premier academic, industry and patient advocacy organizations, Sio is focused on accelerating its candidates through clinical trials to liberate patients with debilitating diseases through the transformational power of gene therapies. For more information, visit http://www.siogtx.com.

Contacts:

Media

Josephine Belluardo, Ph.D. LifeSci Communications(646) 751-4361jo@lifescicomms.cominfo@siogtx.com

Investors and Analysts

Parag V. Meswani, Pharm.D.Sio Gene Therapies Inc.Chief Commercial Officerinvestors@siogtx.com

Continued here:
Sio Gene Therapies to Present at the 10th Annual SVB Leerink Global Healthcare Conference - GlobeNewswire

While youre receiving treatment for cancer, some of the drugs you take can cause painful sores to develop inside your mouth. You can also get them if youve had a bone marrow (stem cell) transplant as part of your cancer care.

Although they often heal on their own, these mouth sores can make it uncomfortable to eat and talk. Well discuss what you can do to relieve the pain and prevent them from getting worse.

Mouth sores can be a common side effect of cancer treatment. The condition, known as stomatitis or mucositis, is an inflammation of the tissues inside your mouth.

Whitish, ulcer-like sores can form on your cheeks, gums, lips, tongue, or on the roof or floor of your mouth. Even if you dont develop mouth ulcers, you may have patches that feel inflamed and painful, as if theyve been burned.

Anyone who is receiving chemotherapy, radiation therapy, or a bone marrow (stem cell) transplant can develop mouth sores as a side effect of these treatments.

If you have dry mouth or gum disease, or if your teeth and gums are not well taken care of, you may be at a higher risk of getting mouth sores during your treatment. Women and people who smoke or drink alcohol are also at a higher risk, according to the Oral Cancer Foundation.

If youre receiving chemotherapy, the sores could begin forming anywhere from 5 days to 2 weeks after your treatment. Depending on the specific cause, the sores could go away on their own in a few weeks, or they could last longer.

Its important to find ways to manage your pain and to watch for signs of an infection. Cancer-related mouth sores can lead to weight loss, dehydration, and other serious complications.

Cancer cells can grow very quickly. The aim of cancer treatment is to stop or slow down that growth. The cells in the mucous membranes lining your mouth are also fast-growing cells, so cancer treatments affect them, too.

Cancer treatments also keep the cells in your mouth from being able to repair themselves efficiently when theyre damaged.

Radiation therapy can also damage the glands in your mouth that make saliva. A dry mouth is more susceptible to infections that cause mouth sores.

Chemotherapy and radiation can both change the microbiome in your mouth, upsetting the balance between good and bad bacteria. The growth of harmful bacteria in your mouth can also lead to mouth sores.

Sometimes cancer treatments suppress your immune system, which may make it more likely that youll get a bacterial, viral, or fungal infection that causes mouth sores. An older infection (such as the herpes simplex virus) can also suddenly flare up again.

If youve had a bone marrow (stem cell) transplant, sores may be a sign that youve developed a condition known as graft-versus-host disease (GVHD).

When this happens, the cells in your body are attacking the transplanted cells as though they were an unhealthy invader. According to research published in Journal of Clinical and Experimental Dentistry, short-term (acute) GVHD occurs in 50 to 70 percent of stem cell transplant cases and longer-term (chronic) GVHD is seen in 30 to 50 percent of cases.

The form of GVHD that causes mouth sores is usually mild, and doctors often treat it with corticosteroid medications.

Its important to talk with your doctor if you develop mouth sores after a stem cell transplant, as some kinds of GVHD can turn serious if left untreated.

There is a good chance that youll experience mouth sores at some point during your cancer treatment. Researchers estimate that 20 to 40 percent of those who have chemotherapy and 80 percent of those who have high-dose chemotherapy will develop mucositis afterward.

Still, there are steps you and your cancer care team can take to lower your risk, reduce the severity of the sores, and promote faster healing.

About a month before your cancer treatment begins, schedule an appointment with your dentist to make sure your teeth and gums are healthy. If you have cavities, broken teeth, or gum disease, its important to come up with a dental treatment plan to take care of these conditions so they dont lead to infections later, when your immune system may be vulnerable.

If you wear braces or dentures, ask your dentist to check the fit and remove any part of the device you dont need during your treatment.

Its very important to maintain good oral hygiene practices throughout your treatment to lower your risk of infection. Brush and floss gently but regularly, avoiding any painful areas. You can also ask your dentist whether a mouth rinse with fluoride is advisable in your case.

For certain kinds of chemotherapy (bolus 5fluorouracil chemotherapy and some high-dose therapies), your healthcare team may give you ice chips to chew for 30 minutes before your treatment. This type of cold therapy can lower your risk of getting mouth sores later.

During treatment of some blood cancers, doctors may give you injections of palifermin, also known as human keratinocyte growth factor-1 (KGF-1), to prevent mouth sores.

If youre scheduled to receive high-dose chemotherapy or radiotherapy, your cancer care team may prepare your mouth using low-level laser therapy beforehand to keep you from getting mouth sores.

For people who have radiation therapy for head and neck cancers, doctors may prescribe this medicated mouthwash to minimize mouth sores.

The length of time your mouth sores may last depends on the specific cancer treatment youve had. Here are some estimates broken down by treatment:

You may notice symptoms anywhere between a few days and a few weeks after your cancer treatment. Heres what you may see and feel as mucositis develops:

You may notice that the sores become slightly crusty as they heal. Its important to keep track of your symptoms and let your oncologist know if the sores arent healing on their own.

Contact your doctor right away if you:

Untreated mouth sores can lead to malnutrition, dehydration, and life-threatening infections.

There are a few different ways that you can help mouth sores heal and avoid prolonger pain or an infection.

While the sores are healing, its very important to keep the inside of your mouth clean to prevent an infection from developing.

The National Cancer Institute recommends that you gently clean your teeth every 4 hours and just before you go to sleep at night. Here are a few tips to consider:

If the pain from mouth sores is interfering with your ability to eat and drink, your doctor may treat the condition with a opioid mouthwash or one containing doxepin or lidocaine.

To ease discomfort and keep your mouth from feeling dry, you may want to try rinsing with a mild saltwater or baking soda solution. Heres how to make each of them:

Your cancer care team may recommend that you use a lubricating liquid (artificial saliva) to moisten the inside of your mouth if dryness is a problem. These liquids are usually gel-like. They coat your mouth with a thin film to help ease discomfort and promote healing.

Some people have found it useful to rinse with a blend of medications called the magic mouthwash. Formulas for this mouthwash vary, but most of them include a combination of medications to treat different symptoms, including:

Magic or miracle mouthwash solutions usually have to be prescribed by a doctor and prepared by a pharmacist, although some people mix up an over-the-counter version at home.

There isnt enough research to say for sure whether magic mouthwash works. If you think youd like to try it, talk with your oncologist or a healthcare professional about whether its a good idea for you.

Here are a few more things you can try at home that may help ease pain from mouth sores:

Mouth sores are one of the most common side effects of cancer treatment. Shortly after chemotherapy, radiation, or transplant treatments, painful, ulcer-like sores can form on the inside of your mouth.

These sores may go away on their own. If they dont, its important to seek medical treatment for them because they can lead to very serious complications.

Before you start cancer treatments, visit a dentist to make sure your teeth and gums are healthy. Keeping up good dental hygiene practices during and after cancer treatment will help limit mouth sores.

If the sores are keeping you from eating and drinking, talk with your oncologist about medications could relieve the pain and speed up the healing process, so you can enjoy a better quality of life during treatment.

Its really important to keep track of any sores in your mouth so you can reach out to your healthcare team if they dont improve. Sores that deepen or worsen can lead to serious even life-threatening complications.

See the article here:
Mouth Sores from Chemo: Symptoms, Causes, and Treatments - Healthline

By Ernie Mundell and Robert Preidt HealthDay Reporters

THURSDAY, Feb. 18, 2021 (HealthDay News) -- Diabetes is a big risk factor for a severe bout of COVID-19, and a new European study bears that out: It finds that 1 in every 5 hospitalized COVID-19 patients with diabetes die within 28 days of admission.

One U.S. expert wasn't surprised by that grim finding.

"Diabetic patients are clearly in a very high-risk category and should be among the first groups of people to get the vaccine," advised Dr. Mangala Narasimhan, who directs critical care services at Northwell Health in New Hyde Park, N.Y. She also advises people with diabetes to make sure they are taking control of their blood sugar levels and avoiding any complications of the disease.

Such steps "seem to really make a difference in terms of survival from COVID infection," said Narasimhan, who wasn't involved in the new study.

The research was led by Bertrand Cariou and Samy Hadjadj, diabetologists at University Hospital Nantes in France. In May of last year they had released preliminary findings that showed that 10% of COVID-19 patients with diabetes died within seven days of hospital admission.

The newer, updated results are from a larger number of patients -- close to 2,800 -- treated for COVID-19 at 68 hospitals across France. Their mean age was 70, nearly two-thirds were men, and many were overweight. About 40% were also experiencing various forms of complications from their diabetes.

During the 28 days after their admission to a hospital, 21% of patients died, the French team reported Feb. 17 in the journal Diabetologia.

Of those patients who survived at least one month, 50% were discharged from the hospital with a median stay of nine days; 12% were still hospitalized at day 28, and 17% had been transferred from their first hospital to another facility.

Younger age, routine diabetes therapy using the drug metformin, and having had symptoms longer prior to hospital admission were key factors associated with a higher likelihood of being discharged from the hospital, the researchers said.

Patients who regularly took insulin -- possibly indicating more advanced diabetes -- had a 44% higher risk of death than those who didn't take insulin, the investigators said. Long-term blood sugar control wasn't associated with patient outcomes, but a higher level of blood sugar at the time of hospital admission was a strong predictor of death and of a lower chance of discharge.

Dr. Barbara Keber directs family medicine at Glen Cove Hospital in Glen Cove, N.Y. Reading over the findings, she said they show "diabetes is clearly a significant risk factor for both need for ICU/ventilator care in the hospital as well as for death" within a month of admission.

Keber said it "makes sense" that people with complications from poorly controlled diabetes are at higher risk, since this creates a "pro-inflammatory state" that is similar to that seen in advanced COVID-19.

But Keber also cautioned that death rates may have improved for COVID-19 patients, including those with diabetes, over the past year.

"This study was done in the first wave of the pandemic, and many of the current treatment regimens and medications that were tried in the early phase have been found to not be beneficial and other treatment regimens have taken their place," she noted.

For example, "the current use of steroids for treatment may play a role in the [improved] prognosis of patients overall and especially for those with diabetes," Keber said.

More information

The American Diabetes Association has more on COVID-19.

SOURCES: Mangala Narasimhan, DO, director, critical care services, Northwell Health, New Hyde Park, N.Y.; Barbara Keber, MD, chair, family medicine, Glen Cove Hospital, Glen Cove, N.Y.; Diabetologia, news release, Feb. 17, 2021

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COVID Deaths High When Hospitalized With Diabetes - WebMD

Diabetic retinopathy is an eye disease that affects people living with diabetes. It develops when high blood sugar damages the tiny blood vessels in the retina. This causes a variety of symptoms like blurry vision and vision loss.

This progressive disease may lead to irreversible vision loss, so its important to have regular eye exams. A doctor can then diagnose the condition early and slow its progression.

Glucose, or blood sugar, is a main source of energy yet too much circulating in the blood can be harmful to the body.

Typically, the pancreas releases the hormone insulin, which helps cells absorb glucose for energy. In the case of diabetes, though, the body doesnt make enough insulin or doesnt use it properly. This causes glucose to accumulate in the blood.

Consistent levels of high blood sugar can affect different parts of the body, including the eyes.

Diabetic retinopathy doesnt only weaken or damage the blood vessels in the eye. It can also cause the development of new abnormal blood vessels in the retina.

Diabetic retinopathy is a progressive eye disease classified by two types and four stages.

The two types are nonproliferative and proliferative. Nonproliferative refers to early stages of the disease, while proliferative is an advanced form of the disease.

This is the earliest stage of diabetic retinopathy, characterized by tiny areas of swelling in the blood vessels of the retina. These areas of swelling are known as micro aneurysms.

Small amounts of fluid can leak into the retina at the stage, triggering swelling of the macula. This is an area near the center of the retina.

Increased swelling of tiny blood vessels starts to interfere with blood flow to the retina, preventing proper nourishment. This causes an accumulation of blood and other fluids in the macula.

A larger section of blood vessels in the retina become blocked, causing a significant decrease in blood flow to this area. At this point, the body receives signals to start growing new blood vessels in the retina.

This is an advanced stage of the disease, in which new blood vessels form in the retina. Since these blood vessels are often fragile, theres a higher risk of fluid leakage. This triggers different vision problems such as blurriness, reduced field of vision, and even blindness.

Diabetic retinopathy doesnt usually cause symptoms during the nonproliferative stages, so its possible to have it and not know it. This is because blood vessels dont always leak in these stages.

Many people dont have symptoms until the disease progresses to proliferative diabetic retinopathy.

However, an eye examination by an eye care specialist or ophthalmologist can detect diabetic retinopathy in its earlier stages, before symptoms become apparent.

Symptoms of proliferative diabetic retinopathy include:

Be mindful, too, that diabetic retinopathy symptoms usually affect both eyes at the same time.

To diagnose diabetic retinopathy, your doctor may complete a comprehensive eye examination. This involves measuring:

Your doctor will likely also dilate your eye to examine your optic nerve and retina using special eye drops.

Doctors can also diagnose diabetic retinopathy with fluorescein angiography, which checks for abnormal blood vessel growth or leakage.

Theyll inject a yellow dye into a vein in your arm, allowing the dye to travel through your blood vessels. A special camera takes images of the dye as it travels through the blood vessels in your retina.

Diabetic retinopathy may lead to irreversible vision loss, but it is treatable. Treatment starts with managing blood sugar and diabetes. This includes taking diabetes medication as directed, watching your diet, and increasing physical activity.

Keeping blood sugar within a healthy range can slow the progression of vision loss.

Other treatments will depend on the stage or extent of the disease. If caught very early before damage to the retina occurs blood sugar management might be the only necessary treatment. Your doctor will continue to monitor your eyes, though, to ensure the disease doesnt progress.

If youre in a nonproliferative stage but experience some eye damage, treatment options might include:

Preventing diabetic retinopathy starts with managing blood sugar.

This involves managing diabetes with medication, balanced eating habits, and regular physical activity. You should also monitor your blood sugar on a regular basis and speak with your doctor if your levels are difficult to manage.

A healthy diet consists of:

Diabetes management may also involve other changes. This can include managing your blood pressure and cholesterol and avoiding tobacco.

Diabetic retinopathy isnt the only complication of diabetes. Blood sugar levels outside of a healthy range can cause other long-term issues, such as:

It may also lead to other conditions involving significant vision loss or blindness, such as:

If you have diabetes, make an appointment to see an eye care specialist such as an ophthalmologist at least once a year, or as often as your doctor recommends.

You should also see your doctor if your glucose level remains high despite medication and other changes, or if you notice any changes in vision, even if they are subtle.

Diabetic retinopathy is a potentially serious eye disease that can result in permanent distorted vision or loss of vision. Any changes in vision, such as blurriness, poor night vision, and an increase of eye floaters, should prompt a trip to the eye doctor.

Speak with your eye care specialist to diagnose any possible eye conditions. Although diabetic retinopathy isnt reversible, it is treatable.

Read more:
Diabetic Retinopathy Stages: The 4 Stages and What to Do - Healthline

Managing diabetes and keeping your blood sugar within a healthy range doesnt only protect against heart attacks and stroke, it can also keep your feet healthy.

Diabetes is a condition where the body doesnt produce enough insulin or use insulin properly, causing sugar levels in the blood to rise above normal. Uncontrolled high blood sugar can reduce blood flow in your feet, leading to serious complications.

Paying attention to your foot healthwhich includes recognizing early signs of problemsand maintaining a healthy blood sugar lowers the risk for complications.

Prolonged high blood sugar can gradually damage your blood vessels, restricting blood flow to your organs and other parts of your body. Lack of blood flow can lead to heart disease, stroke, kidney problems, and even vision problems.

Blood vessel damage also affects blood flow to your feet, causing a number of foot health issues.

According to the Centers for Disease Control and Prevention (CDC), about half of people living with diabetes will develop some kind of diabetic neuropathy or nerve damage. This damage can occur anywhere in the body, but usually affects the nerves in the feet and the legs.

Nerve damage can cause a tingling sensation and pain in your feet. As your condition worsens, you might lose all feeling in your feet. This is when diabetic neuropathy becomes dangerous.

Pain is a warning that something isnt right in the body. It can alert you to cuts, sores, and blisters on your feet. But if you have diabetic neuropathy and lose feeling in your feet, a cut or blister could go unnoticed for an extended length of time. If you dont receive prompt treatment for these types of injuries, you could develop an infection.

Diabetic neuropathy can lead to other complications. Reduced blood flow to your feet means that sores or infections might not heal as easily. Infections that dont heal can progress to gangrene, which is death of tissue due to lack of blood flow.

If gangrene starts to affect other parts of your body, your doctor might have to amputate a toe, foot, or leg to stop its spread.

Diabetes can also cause a circulation disorder known as peripheral vascular disease. This cardiovascular disease results from limited blood flow to the legs and feet. A blockage or narrowing of blood vessels also restricts blood flow.

This condition can occur in anyone, but the risk is higher in people with diabetes, because blood vessel changes often prevent the smooth flow of blood. Plus, high blood sugar can thicken blood to the point where it doesnt flow easily.

Nerve damage from diabetes can also trigger a rare condition known as Charcot foot. This typically occurs when a person has an injury, such as a sprain or fracture, that goes unnoticed due to lack of sensation caused by peripheral neuropathy. As the person continues to walk on the injured foot, it causes trauma to the bone.

Deformity occurs when joints become dislocated and collapse. The arch of the foot will often collapse, too, causing a roundness on the bottom of feet.

Along with foot deformity, other signs of Charcot foot include swelling, and your feet might appear red and warm to the touch.

A round bottom on feet also raises the risk of sores due to friction. If you have diabetic neuropathy and lose feeling in your feet, an open sore can become infected. This puts you at risk for amputation.

Poor blood circulation and blood flow can slow the healing process of sores on your feet, putting you at risk for serious life-threatening complications.

Even if you havent lost feeling in your feet, bring the following symptoms to your doctors attention. Signs of feet issues include:

You can avoid serious diabetes complications by seeing your doctor and getting treatment early for conditions that affect your feet.

Unfortunately, theres no cure for diabetic neuropathy. But you can take steps to slow the progression of this disease. Your doctor will likely recommend pain medication to help alleviate nerve pain.

For mild nerve pain, you can take over-the-counter medications like acetaminophen or ibuprofen. For moderate or severe pain, prescription medications like anti-seizure drugs and antidepressants can help ease nerve pain and improve the quality of your life, too.

Maintaining a healthy weight and regular physical activity can also slow the progression of diabetic neuropathy.

If you develop peripheral vascular disease your doctor will also recommend treatment to slow disease progression and improve blood flow.

Regular exercise, eating a healthy, balanced diet, and losing weight can help improve blood flow, as does quitting smoking. Smoking restricts blood vessels.

Treatment might also involve medication to reduce blood clotting, lower your cholesterol, or reduce your blood pressure depending on the underlying cause of a blockage.

Good diabetes managementmedication, regular exercise, and a healthy dietcan also reduce symptoms of peripheral vascular disease.

In severe cases, you may need angioplasty for peripheral vascular disease. This is a surgical procedure to open up a blocked artery and restore blood flow.

Gangrene treatment involves antibiotics to kill bacteria and stop an infection, as well as surgery to remove damaged tissue. Treatment for Charcot foot involves preventing further deformity.

Wearing a cast to immobilize the foot and ankle can gradually strengthen these bones, as does wearing custom shoes or a brace. In severe cases, surgery can help correct a deformity.

One way to prevent foot issues with diabetes is to keep your blood sugar within a healthy range, so check your blood sugar on a regular basis. Also, take your diabetes medication as instructed. If youre unable to control your blood sugar, see your doctor.

Other tips to prevent foot issues include:

Not only should you take steps to keep your blood sugar within a healthy range, you should also take steps to keep your feet healthy. Heres how to protect your feet with diabetes:

Some diabetes foot complications are life-threatening, or they put you at risk for amputation. See a doctor if you have any concerns or notice unusual changes with your feet.

A seemingly minor issue like cracked skin on your feet, yellow toenails, athletes foot, or an ingrown nail can become a serious problem if left untreated. Also, see your doctor for any cuts or scrapes that dont heal to avoid an infection on your feet.

Although theres no cure for diabetes, a healthy diet, regular exercise, and taking your medication as instructed can lower your risk for complications.

Its very important to keep your feet healthy when you have diabetes. Check your feet daily for signs of injury or infection, and see your doctor right away if you notice any unusual symptoms.

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Diabetic Feet: Issues, Treatment, and Prevention - Healthline

United Nations Secretary-General, Antnio Guterres, and World Health Organization (WHO) Director-General, Dr Tedros Adhanom Ghebreyesus, have announced that a Global Diabetes Compact will be launched on 14 April 2021 to mark the 100-year anniversary of the discovery of insulin for the treatment of diabetes. The centenary offers a window of opportunity for the global diabetes community to come together to reflect on addressing barriers to accessing insulin and associated health technology products. It is an opportune time to forge a common vision among all stakeholders to develop a multisectoral plan of action to address these barriers and ensure that no person living with diabetes goes untreated.

The WHO Department of Noncommunicable Diseases (NCD), in collaboration with the Division of Medicines and Health Products, is convening a series of biannual dialogues with the private sector to define meaningful and effective contributions to the implementation of national responses for the prevention, management and control of NCDs and the attainment of related Sustainable Development Goal (SDG) targets. The dialogues will focus on mobilizing commitments and contributions by the private sector toward national NCD responses to achieve SDG targets 3.4, 3.8 and 3b by improving access to and affordability of safe, effective and quality-assured medicines and health technology products.

Improving access to medicines and health technology products for the diagnosis, management and treatment of diabetes is multi-faceted and part of a broader challenge of ensuring access to health care. It requires a robust health system which includes good leadership and governance, adequate financing, access to information and evidence, quality service delivery, a strong health workforce, and equitable access to essential medicines and health technology products of assured quality, safety, efficacy and cost-effectiveness. Effective interventions will require enhanced collaboration and commitment for greater impact at country-level. The first dialogue in the series, which is being held on 23-24 February 2021, will focus on improving access to human insulin and associated health technology products for diabetes as part of the Global Diabetes Compact. Subsequent dialogues will focus on other NCDs, such as cardiovascular disease, cancer, lung diseases, oral health, rehabilitation, sensory impairments and disability.

This first dialogue aims to encourage inputs, commitments, and contributions from the pharmaceutical and health technology product industries to support WHOs activities to improve access to medicines and health technology products for diabetes, including for the 14 April 2021 launch of the Global Diabetes Compact.

A summary report of this meeting will be available on this website after the meeting.

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Dialogue with the private sector on medicines and technologies for diabetes care, February 2021 - World Health Organization

Welcome to Connecting the Dots on Diabetes, a series by Sydney Williams of Hiking My Feelings chronicling the organizations mission to hike 1 million miles for diabetes awareness in 2021.

Throughout the series, Sydney, who received a diagnosis of type 2 diabetes in 2017, will interview diabetes advocates, community organizers, policy makers, and patients to answer the question: Is there a relationship between trauma and diabetes? If so, if we treat the trauma, can we more effectively treat diabetes?

When I was first diagnosed with type 2 diabetes, I had a lot of questions. What is happening inside my body? What can I eat? Will I be on medications for the rest of my life?

There are a ton of resources available to answer these questions, but I wanted to take my health into my own hands and be my own best advocate.

In the wake of this diagnosis, I came to a shocking realization: I didnt really know myself.

Sure, I had been existing in this body on this planet for 32 years when I got the call that changed my life, but who was I really? What did I believe? What had I internalized from society, my parents, my coaches, and other people in my life?

How had that informed my life choices, circumstances, and overall outlook on what life should be? I realized I was living the life I thought I should be living, not one of my own design.

Ive said it before and Ill say it again, diabetes is the best thing that ever happened to me.

Just 9 months before my diagnosis, I started backpacking.

It was December 2016, and this was the next chapter of my healing journey. I had no idea how my life would unfold when I went on that trip, but it undeniably changed my life on a cellular level.

When I got home, I was sore for 3 weeks. I couldnt walk right and my feet were healing from an onslaught of blisters from ill-fitting shoes and a lack of physical preparation. Yet, at the same time, I felt a deep love for the body I had been occupying for the 31 years prior to that hike.

I didnt know how my life would change or who would help me get to where I wanted to go, but for the first time, I was clear on what I wanted and why. I wanted to be fit, to get healthy. Not a new goal for me in January, but this time it was different.

I fell in love with backpacking on that trip. I fell in love with how my body felt in the wilderness, the healing power of nature, and how refreshed and clearheaded I felt when it was all said and done.

Despite the blisters and aches and pains, I came home a new woman and I wanted to honor that new woman with every step I took for the rest of my life.

I wanted to be able to hike as much as possible and enjoy the experience. If there was any way I could do more hiking and backpacking and not have my body get in the way of the miles I wanted to do per day, or how many days I could be out in the backcountry in a row, I wanted to explore that.

So I did.

I picked up paddleboarding during the summer of 2017 and declared to myself that I was a multi-sport athlete. When it was too hot to hike, Id be on the water. When it was too cold to paddle, Id be in the mountains.

For all of my life, I never called myself an athlete because I figured if I wasnt going to the Olympics and winning gold medals, then who am I? In that moment, I squashed that old story and wrote a new one: Im an athlete. Time to live like one.

After a summer full of paddleboarding, I was diagnosed with type 2 diabetes. As it got cooler and paddleboarding wasnt as appealing, I started walking every day around my neighborhood, eventually graduating to local hiking trails.

Slowly but surely, my life started to change before my eyes.

On my walks and hikes, I didnt listen to music, podcasts, or audiobooks. My phone stayed in my pocket. I was able to hear my inner voice.

Intense physical activity brought up lots of painful memories. When my body started getting tired, my brain told me wild stories about how Im too fat and too out of shape to be out here.

I didnt like how I was talking to myself and I remembered my first backpacking trip, where I learned how to be my own best friend.

Instead of running away from difficult feelings and memories, or numbing them with alcohol or ice cream, I listened.

When I started to peel back the layers of the life I had built for myself, I gained context and insights about the life events that led to the behaviors that contributed to my diagnosis.

I repeated that 2016 backpacking trip in June 2018, 10 months into my journey managing diabetes, and once again, my life was changed.

Without all the distractions of life, I was able to connect the dots between trauma I had experienced earlier in my life (a sexual assault in college) and how, when I didnt get help, I started coping by eating and drinking my feelings.

After more than a decade of neglecting my health, I was diagnosed with type 2 diabetes.

When I cut out the harmful behaviors and started hiking and tending to my mental health, my A1C improved, and my daily readings were in the healthy zone.

Diabetes, especially type 2 diabetes, has a horrible stigma around it. A common trope is that we made unhealthy choices and brought it on ourselves.

While I did make some unhealthy choices, the trauma of the sexual assault is what informed those choices. For some people with diabetes, lifestyle plays no role.

We could all stand to have a bit more empathy and compassion for folks who have diabetes. Every experience with diabetes is personal.

In the wake of my diagnosis and subsequent love for hiking, I founded a nonprofit organization called Hiking My Feelings. We started in 2018, and since then weve hosted more than 200 events around the United States introducing people to the healing power of nature.

My work explores how trauma manifests in our minds and bodies, and how the outdoors can help us heal. The question were looking to explore in 2021 is a big one:

Is trauma a root cause of diabetes? If so, if we address the trauma, can we manage diabetes more effectively?

The inspiration for addressing this question came as a result of my own journey navigating type 2 diabetes. Once I faced the trauma head-on and addressed my mental health, my physical health followed closely behind.

According to 2018 data from the Centers for Disease Control and Prevention (CDC) on the prevalence of diagnosed diabetes in America, some of the most disturbing statistics come to light when breaking the prevalence down by race:

If you look at these groups and think about issues like poverty, access to healthcare, education, food deserts (and food swamps), the pay gaps in America, and the historical trauma experienced by these communities colonization, racism, slavery, oppression, systemic issues then its even more evident that trauma could be a root cause of diabetes.

In this column, you can look forward to interviews with the people who are working to make the world a better place by means of diabetes awareness and education, learn about hiking and walking for mental and physical health, and hear from the community leaders, organizations and brands who are helping increase accessibility of recreation opportunities in marginalized communities.

This year, we are on a mission to hike 1 million miles for diabetes awareness and were taking our work on the road through our Take a Hike, Diabetes tour.

Obviously, we cant hike 1 million miles in a year by ourselves, so were counting on our community and all of the friends we havent met yet to help us meet and exceed our goal.

Were just getting started, and its never too late to join us. Healing happens one step at a time.

Sydney Williams is an adventure athlete and author based in San Diego. Her work explores how trauma manifests in our minds and bodies and how the outdoors can help us heal. Sydney is the founder of Hiking My Feelings, a nonprofit organization on a mission to improve community health by creating opportunities for people to experience the healing power of nature. Join the Hiking My Feelings Family, and follow along on YouTube and Instagram.

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Connecting the Dots on Diabetes: My Mission to Address the Root Cause of Diabetes - Healthline

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In Phase III studies, Eli Lillys tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes.

This morning, Indianapolis-based Eli Lilly said tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, hit the mark in both the Phase III SURPASS-3 and SURPASS-5 Phase III clinical trials after 52 weeks and 40 weeks, respectively.

In the 52-week SURPASS-3 study, the longest in the program to date, the highest dose of tirzepatide reduced A1C by 2.37% and body weight by 28.4 pounds, a 13.9% reduction. Study participants were insulin-nave and had a mean duration of diabetes of 8.4 years, a baseline A1C of 8.17% and a baseline weight of 94.3 kg, 207 pounds.

Results showed that all three tirzepatide doses (5 mg, 10 mg and 15 mg) led to superior A1C and body weight reductions compared to titrated insulin degludec. Lilly noted that 92.6% of participants on tirzepatide achieved an A1C of less than 7%, which is the American Diabetes Association's recommended target for people with diabetes. Additionally, up to 48.4% of participants treated with tirzepatide achieved an A1C of less than 5.7Z%.

In the SURPASS-5 study, tirzepatide reduced A1C by 2.59% and body weight by 10.9 kg, an 11.6% change. Study participants had a mean duration of diabetes of 13.3 years, a baseline A1C of 8.31%, a baseline weight of 95.2 kg, about 210 pounds, and a baseline insulin glargine dose of 37.6 units per day. All three doses of tirzepatide demonstrated superior A1C reductions and weight reductions from baseline compared to placebo.

Across the three doses, up to 97.4% of participants on tirzepatide achieved an A1C of less than 7%. Also, 62.4% of participants treated with the highest dose of tirzepatide achieved an A1C of less than 5.7%.

Mike Mason, president of Lilly Diabetes, hailed the results demonstrated by tirzepatide in the two studies.

Tirzepatide delivered impressive A1C and body weight reductions in both studies and continued to achieve consistent efficacy and safety results in people living with type 2 diabetes, regardless of how long they have had the condition," Mason said in a statement. Significantly lowering A1C levels and weight are high priorities throughout the type 2 diabetes treatment journey, and the results we have seen from three SURPASS studies to date fuel our belief in tirzepatide's ability to meet those needs.

There are approximately 34 million people in the United States and about 463 million people in the world who have a form of diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90% to 95% of all diabetes cases inthe United Statesalone

Tirzepatide integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. Eli Lilly said the integration of both incretins represents a new class of medicines being studied for the treatment of type 2 diabetes. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight.

Tirzepatide is in Phase III development for blood glucose management in adults with type 2 diabetes and for chronic weight management. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).

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Studies: Lilly's Tirzepatide Reduces A1C and Weight in Type 2 Diabetes Patients - BioSpace

Dr Natalie A. Cameron

Roughly 40% of all US cases of incident diabetes during 2013-2016 were directly attributable to obesity, a finding that further solidifies the major etiologic role for obesity in the current American diabetes epidemic.

Researchers used data from a diverse cohort of 4200 American adults in the MESA study during 2000-2017 to calculate a relative risk for developing diabetes of 2.7 in people with obesity compared with similar participants without obesity.

They then applied this relative risk estimate to obesity prevalence rates during serial iterations of NHANES, the recurring US-wide survey of vital statistics in a representative cross-sectional population.

Their calculations showed that, during 2013-2016, 41% of US adults who developed new onset diabetes did so because of obesity, after adjusting for potential confounders.

This "population attributable fraction," or disease burden attributable to obesity, varied somewhat by sex, and by racial and ethnic subgrouping. Obesity was linked with the highest attributable rate among non-Hispanic White women, a rate of 53%, and with the lowest rate among non-Hispanic Black men, with an attributable fraction of 30%, Natalie A. Cameron, MD, and colleagues report in their study, published online February 10 in the Journal of the American Heart Association.

"Our study highlights the meaningful impact that reducing obesity could have on type 2 diabetes prevention in the United States. Decreasing obesity needs to be a priority," said Cameron, of the McGaw Medical Center of Northwestern University in Chicago, Illinois, in a statement issued by the American Heart Association.

"Public health efforts that support healthy lifestyles, such as increasing access to nutritious foods, promoting physical activity, and developing community programs to prevent obesity, could substantially reduce new cases of type 2 diabetes," she added.

MESA (Multi-Ethnic Study of Atherosclerosis) enrolled adults 45-84 years old and free from clinical cardiovascular disease at six US sites during 2000-2002, and then followed them with four additional examinations through 2017.

For the current study, researchers narrowed the cohort down to 4200 participants who were 45-79 years old and free from diabetes at entry, and also restricted this subgroup to participants classified as non-Hispanic White (54% of the cohort), non-Hispanic Black (33%), or Mexican American (13%). At entry, 34% of the cohort had obesity, with a body mass index of at least 30 kg/m2.

During a median follow-up of just over 9 years, 12% of the cohort developed incident diabetes. After adjusting for possible confounders, a hazard ratio model showed an overall 2.7-fold higher rate of incident diabetes among people with obesity compared to those without.

The researchers then applied this hazard ratio to obesity prevalence statistics from NHANES (National Health and Nutrition Examination Survey) during the same time period, with data from the biennial NHANES project collapsed into four time strata: 2001-2004, 2005-2008, 2009-2012, and 2013-2016. They again limited their analysis to NHANES data collected from people 45-79 years old who self-reported categorization as non-Hispanic White, non-Hispanic Black, or Mexican American.

During the period from 2001-2004 to 2013-2016, overall obesity prevalence tallied by NHANES data rose from 34% to 41%. Among people with type 2 diabetes during 2013-2016, obesity prevalence was 65%.

To calculate the population attributable fractionresearchers combined the MESA and NHANES estimates and adjusted for potential confounders and foundthat, overall, in 41% of people with incident diabetes during 2013-2016, the disease was attributable to obesity.

J Am Heart Assoc. 2021;10:e018799. Full text

The study received no commercial funding, and none of the authors had disclosures.

For more diabetes and endocrinology news, follow us on Twitter and Facebook. Follow Medscape on Facebook, Twitter, Instagram, and YouTube.

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Obesity Pegged as Diabetes Cause in Almost Half of US Cases - Medscape

Numerous studies have demonstrated the role of physical activity in improving heart health for patients with Type 2 diabetes. But whether exercising at a certain time of the day promised an added health bonus for this population was still largely unknown.

New research published inDiabetes Care reports a correlation between the timing of moderate-to-vigorous physical activity and cardiovascular fitness and health risks for individuals who have Type 2 diabetes and obesity or overweight.

The research team fromBrigham and Womens Hospitaland Joslin Diabetes Center investigators, along with collaborators found that, in its study of 2,035 people, men who performed physical activity in the morning had the highest risks of developing coronary heart disease (CHD), independent of the amount and intensity of weekly physical activity. Men most active midday had lower cardiorespiratory fitness levels. In women, the investigators did not find an association between specific activity timing and CHD risk or cardiorespiratory fitness.

The general message for our patient population remains that you should exercise whenever you can as regular exercise provides significant benefits for health, said corresponding authorJingyi Qian of theDivision of Sleep and Circadian Disordersat the Brigham and an instructor of medicine at Harvard Medical School. But researchers studying the effects of physical activity should take into account timing as an additional consideration so that we can give better recommendations to the general public about how time of day may affect the relationship between exercise and cardiovascular health.

The researchers analyzed baseline data from the Look AHEAD (Action for Health in Diabetes)study, a multi-site, randomized clinical investigation that began in 2001 and monitored the health of more than 5,000 individuals with Type 2 diabetes and overweight or obesity. Among them, over 2,000 individuals had objectively measured physical activity at baseline.

The study population was very well characterized at baseline, with detailed metabolic and physical activity measurements, which was an advantage of using this dataset for our work, said corresponding author Roeland Middelbeek of the Joslin Diabetes Center, who is a co-investigator of the Look AHEAD study.

For theDiabetes Carearticle, the researchers reviewed data from hip-mounted accelerometers that participants wore for one week at the beginning of the Look AHEAD study. The researchers tracked the clock-time of daily moderate-to-vigorous activity, including labor-intensive work that extends beyond more traditionally defined forms of exercise. To assess the participants risk level of experiencing CHD over the next four years, the researchers used the well-known, sex-specificFramingham risk score algorithm.

Sex-specific physiological differences may help explain the more prominent correlations seen in males, who tend to be at risk of CHD earlier in life. However, the researchers note that other factors could also be at play. It remains unclear why time-specific activity may be associated with different levels of health and fitness.

The researchers also could not account for participants varying circadian rhythms: whereas a jog at 6 p.m. for one participant may be evening exercise, another participant prone to waking later in the day may, biologically, consider it to be afternoon, regardless of how the clock-time of the activity was recorded in the study.

Interest in the interaction between physical activity and the circadian system is still just emerging, Qian said. We formed a methodology for quantifying and characterizing participants based on the clock-time of their physical activity, which allows researchers to carry out other studies on other cohorts.

Beyond further integrating circadian biology with exercise physiology, the researchers are also excited to use longitudinal data to investigate how exercise timing relates to cardiovascular health outcomes, particularly among diabetes patients more vulnerable to cardiovascular events.

Other contributors to the research include Michael P. Walkup, Shyh-Huei Chen, Peter H. Brubaker, Dale S. Bond, Phyllis A. Richey, John M. Jakicic, Kun Hu, Frank A.J.L. Scheer, and the Look AHEAD Research Group.

Funding was provided by the National Institutes of Health. National Heart, Lung, and Blood Institute (K99HL148500). The Look AHEAD trial was supported by the Department of Health and Human Services through the following cooperative agreements from the National Institutes of Health (DK57136, DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135, and DK56992). The Indian Health Service (I.H.S.) provided personnel, medical oversight, and use of facilities.

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Timing of exercise impacts men with Type 2 diabetes - Harvard Gazette

To understand the new findings, one has to take ina bit of basic research.The focus here is on two messenger substances that researchers at Helmholtz Zentrum Mnchen, the German Center for Diabetes Research (DZD), ETH Zurich and Indiana Universityfeel show particular promise. These substances aregastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 (GLP-1).

GIP and GLP-1 are produced in the digestive tract and play vitalroles in regulating body weight and food intake. A study on their effects now published in the journal Cell Metabolism provides pointersfor developing drugs to treat obesity and type 2 diabetes.

GIP acts on receptors of the central nervous system located in the brain, stimulatingthe release of insulin and loweringblood glucose levels. But how exactly this works has not been clear until now.

First author Qian Zhang and her team had two different types of mice at their disposal for their experiment: normal wild-type mice and specially bred mice that lacked the GIP receptors in the brain. The researchers injected both typeswith GIP.

Mice naturally have GIP receptors, but for the trial, scientists used specially bred mice without them

It was found that body weight and food intake decreasedin the wild-type mice, indicatingthat the hormone has an effect on appetite regulation. In contrast, food intake remained the same in the special laboratory mice lacking the GIP receptor. Their body weight decreased only minimally.

The researchers also looked at the mice's brain activity. "After administration of GIP, increased neuronal activity was evidentin the area of the hypothalamus associated with the control of appetite ," says Christian Wolfrum of ETH Zurich.

As far as the treatment of type 2 diabetesgoes, it isGLP-1 that plays an important role. It enhances the glucose-dependent release of insulin from the cells of the pancreas. Diabetics do not produce enough insulin themselves and have to inject it regularly.The problem is that GLP-1 is broken down again very quickly in the body and has to be constantly produced again. A solution to this problem has been available since 2005: a drug called Exenatide from AstraZeneca.

This contains an active ingredient derived from the saliva of the North American Gila monster, a venomous lizard.Itacts in a similar wayto GLP-1but is not broken down as quickly by the body.

The active ingredient is therefore an "agonist." This means that it mimics the action of a hormone at a receptor and stimulates the receptor in the same way.

A similar approach usingGLP-1 and GIP agonists had already been taken by researchers at Helmholtz Zentrum Mnchen together with colleagues from Indiana University. They had combined two hormones in a single molecule that acts on and stimulates both GIP and GLP-1 receptors.

This dual agonist simultaneously lowers weight and improves blood glucose levels. The researcherspublished their research in Science Translational Medicine in 2013.

The compound has now already entered a phase III clinical trial. It has been shown that the combination drug reduces body weight more than just one molecule does when acting at the GLP-1 receptor.

In the more recent mouse trial, it became clear, however,that the drug had no effect in mice lacking the GIP receptor in the brain. "Our work shows for the first time that the GLP-1/GIP dual agonist requires the GIP receptor in the brain to reduce body weight and food intake," saidTimo Mller, last author of the new study and head of the Institute for Diabetes and Obesity (IDO) at Helmholtz Zentrum Mnchen.

His next goal is now to find further active substances to improve GIP receptor signalingbecause these appear to be the central mechanism for treating both conditions.

Sugar is converted to fat in the body about two to five times more quickly than starches. In other words, when we consume sugar, were feeding our fat cells. The fructose in sugar is also metabolized by the liver, which can contribute to fatty liver disease. That can promote insulin resistance and lead to Type 2 diabetes with a lifelong impact on your health.

In small amounts, sugar promotes the release of serotonin, a hormone that boosts mood. But too much sugar can promote depression and anxiety. Sudden shifts in blood sugar levels can also lead to irritability, anxiety and mood swings.

We already know that sugar has a variety of health effects, but it also affects the skin. Thats in part due to glycation, the process whereby sugar molecules bind to collagen fibers. As a result, the collagen fibers lose their natural elasticity. Excess sugar also damages microcirculation, which slows cell turnover. That can promote the development of wrinkles, make you look older than your age.

The microflora of your gut promote digestion and protect your digestive system from harmful bacteria. Consuming too much sugar gets your gut microflora out of whack. Fungi and parasites love sugar. An excess of the Candida albicans yeast can lead to a host of annoying health symptoms. And sugar also contributes to constipation, diarrhea and gas.

In overweight people, the brain responds to sugar by releasing dopamine, in much the same way that it responds to alcohol or other addictive substances. Test it yourself: avoid all sugary foods and beverages for ten days. If you start to get headachy and irritable after a day or two, and start craving sugar, then you could be suffering from sugar withdrawal.

People who consume excess sugar are more likely to engage in aggressive behavior. Children with ADHD are also affected by sugar. For these children, too much sugar affects concentration and promotes hyperactivity. Thats why its a good idea for children to avoid eating sugar during school hours.

Excessive sugar consumption makes it harder for the immune system to ward off disease. After consuming sugar, the immune systems ability to kill germs is reduced by up to 40 percent. Sugar also saps the bodys store of vitamin C, which white blood cells need to fight off viruses and bacteria. Sugar also promotes the inflammatory response, and even minor inflammation can trigger numerous diseases.

Studies have shown that excess sugar consumption increases the risk of developing Alzheimers disease. A 2013 study showed that insulin resistance and high blood sugar values both of which are common in diabetes are associated with a higher risk of neurodegenerative diseases such as Alzheimers.

Cancer cells need sugar to proliferate. An international research team headed by Lewis Cantley of Harvard Medical School is researching how sugar might contribute to the growth of malignant cells. He believes that refined sugar may be what causes cancer cells to develop into tumors. Hes still testing that hypothesis but recommends that even slender people consume as little sugar as possible.

Excess sugar consumption may have a negative impact on memory. According to a study carried out by Berlins Charit University Hospital, people with high blood sugar levels have a smaller hippocampus the part of the brain thats key to long term memory. In the study, people with high blood sugar also performed more poorly on tests of memory than those with low blood sugar levels.

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Obesity and diabetes drug could be on the way - DW (English)

A diabetes education program, offered virtually by the Alabama Cooperative Extension System, will begin next in March, according to an announcement from the Lawrence County Extension Office.

The Diabetes Empowerment Education Program (DEEP) will be offered in six 30-minute to hour-long sessions online, beginning March 24.

"Let's have a DEEP conversation about managing your diabetes," Regional Agent Elaine Softly, who will lead the program, said.

About 610,458 Alabamians live with diabetes, notes Softley. Every year, an estimated 31,000 state residents are diagnosed with diabetes.

She added that diabetes and prediabetes cost an estimated $5.4 billion in Alabama each year, and serious complications from the conditions include heart disease, stroke, amputation, end-stage kidney disease, blindness and even death.

Softley's series will cover topics: Understanding the Human Body, Understanding Risk Factors for Diabetes, Monitoring Your Body, Being Physically Active, Planning Meals, Identifying and Preventing Complications, Learning about Medications & Medical Care, and Living with Diabetes: Mobilizing Your Family and Friends.

For those without access to reliable internet service, other program participation options may be available, according to Extension Coordinator Donna Shanklin.

"The program can be delivered face-to-face to established groups, such as a quilt group, church members, or book clubs, as long as they are following COVID-19 guidelines," Shanklin said. "Just give the office a call to see if Softley can fit you into her schedule. If you do not have access to the internet, we can offer the use of our facilities for a limited number of people following COVID-19 guidelines."

Online sessions will take place at noon on March 24, March 31, April 7, April 14, April 21 and April 28.

Questions may be directed to Elaine Softley by calling 256-324-2851, or by emailing es0021@aces.edu. The Lawrence County Extension Office, located on Alabama 157 in Moulton, may be reached by calling 256-974-2464.

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Extension system to offer diabetes education program this spring - Moulton Advertiser

Two weeks ago, I tore the meniscus of my right inner knee as I got off my stationary exercise bike. The pain of the injury didnt show up until a few mornings later -- getting out of bed, I set my foot onto the floor and immediately raised a yelp of misery.

At the orthopedist office, the doctor drained fluid from the knee and injected cortisone with the largest needle I had ever seen. Thankfully, the injection worked, and after a few days of ice and rest, I was cleared to return to my regular activities.

But I didnt. Instead of returning to my daily exercise routine, I stayed put as my bike and weights gathered dust. I didnt take walks outside; I didnt hit my yoga mat.

It wasnt only exercise I abandoned: I didnt take my blood sugars. I stood in the kitchen and -- ignoring years of "clean eating" -- downed six homemade chocolate chip cookie bars. I pushed the scale into the closet and avoided mirrors.

I had hit the wall when it came to my diabetes care. I was officially burned out.

What is diabetes burnout? Its when the emotional toll of taking care of your disease becomes overwhelming and, for whatever reason, you give up. In my case, my knee injury was the final straw that sent me over the edge; but the truth is, but there had been so much else leading up to it. The long pandemic months that kept us mostly inside, unable to visit family or friends. The death of my sisters mother-in-law earlier that week (a lovely, warm woman who dealt with her own late-in-life diabetes by permitting herself two -- exactly two -- Raisinets a night). The frustrating inability of my husband or myself to schedule a COVID-19 vaccine in our state despite our eligibility. The 21-degree weather with more snow and ice headed our way; the very notion that my beloved Bruce Springsteen had sold out and narrated an ad for the Super Bowl. The masks. The handwashing.

Everything.

There are many, many reasons for diabetes burnout. For some, it arrives when you get a complication even though youve done your best to take care of your disease. Or when despite every effort, the scale refuses to budge. Or high-sugar readings never drop. And it can take many forms: You might refuse to go to your doctor. Or stop monitoring your food. Or "forget" to renew your medications.

Most of us experience diabetes burnout at some point. No matter the cause, the signs and symptoms are the same: Youre sick of being sick, and you cant take it anymore.

For a week, that was me. So how did I deal? I made myself some rules:

1. No beating myself up. I gave myself the right to be sick of my disease.

2. I acknowledged that it couldnt last forever. As delicious as it was to pretend that I didnt have to care for my diabetes, I knew it couldnt last. I decided to call my time away from diabetes a vacation. Since I couldnt take a vacation during the pandemic, I reasoned, a short escape from diabetes might be the best Id get.

3. There were limits. I didnt down sleeves of Oreos or gallons of ice cream, but I did let loose: making spaghetti for dinner one night (white pasta!) and adding a glass of wine or two (or three). I exercised if I felt like it, but I didnt push myself to get a certain number of cardio minutes. If I felt like stopping, I did.

4. Medications were non-negotiable. I continued to take my medications (some habits survive burnout), but I ignored my sugar readings. (I really didnt want to know.)

5. I reached out for support. I talked to a friend about what I was going through and let her remind me of how careful I normally was, and how, maybe, I had needed to take a break to power through.

At the weeks end, I had put on a few pounds. When I got back to testing my sugars, my first reading wasnt great -- but it wasnt horrific either. I dumped the cookie bars and went food shopping for new items that were healthy, low carb, and a little off the beaten track: Japanese eggplant, portobello sliders, low-carb tortillas, a bottle of oyster sauce -- to regain my interest in healthy food.

Lets be clear: Burnout sucks, and it can hurt your health. Diabetes care is best when it's consistent and ongoing. If you find yourself experiencing diabetes burnout, contact your doctor or diabetes educator. They can help you get back on track by reminding you of your earlier progress or setting you up with a regular support group. In these difficult days, we need all the help we can get.

WebMD Blog

Ilene Raymond Rush is an award winning health and science freelance writer. Based on her own experiences with type 2 diabetes, she brings a personal take and a reporters eye to examine the best and newest methods of treating and controlling the disease.

Read the original post:
Diabetes Burnout: What It Is and How to Handle It - WebMD

A billboard in Johnston County suggests North Carolina Gov. Roy Cooper is shortchanging people with type 1 diabetes.

A WRAL viewer emailed a photo of the billboard on U.S. Highway 301 to PolitiFact. It says:

"Gov Roy Cooper does not consider Type 1 diabetes an under lying health issue! Think about that!"

The billboard does not show who paid for it. Warren Stancil, the president of the billboard company, InterState Outdoor Inc., said he doesnt know the buyers identity.

"This was an anonymous person who bought the ad space. All I know is whats in the message," Stancil said in an email. The ad went up around Jan. 22, he said.

Given the timing of the message in the midst of a vaccine rollout, were assuming for the purposes of this check that the messenger is likely referring to where diabetics fall in North Carolinas inoculation schedule.

The billboards message touches on a controversial subject. To date, the U.S. Centers for Disease Control and Prevention does not consider both types of diabetes to carry the same level of risk for COVID-19 complications. In North Carolina, meanwhile, the health department has grouped Type 1 and Type 2 diabetes together and people with either condition qualify for covid vaccines in Group 4, ahead of the general population.

Type 1 diabetes and COVID-19

The CDCs webpage about how the virus affects people with medical conditions says people with Type 2 diabetes are at increased risk, while people with Type 1 diabetes "might" be at increased risk.

Under current CDC recommendations, people with Type 1 diabetes would be vaccinated with the general population.

Advocacy groups such as the American Diabetes Association and JDRF (formerly known as the Juvenile Diabetes Research Foundation) are lobbying the CDC to place higher priority on people with Type 1 diabetes.

A study published in December found that Type 1 diabetes "independently increases the adverse impacts of COVID-19," while another recent study found that Black COVID-19 patients were more likely to develop a serious complication of Type 1 diabetes than white patients.

Still, JDRF spokeswoman Cynthia Rice said that, as a result of the CDCs recommendations, "many states" havent prioritized people with Type 1 diabetes. So the American Diabetes Association has been contacting governors and state agencies across the country, spokeswoman Daisy Diaz told PolitiFact.

Type 1 diabetes and North Carolina

In North Carolina, the health department currently considers both types of diabetes to be "chronic conditions." Where does that put diabetics in North Carolinas vaccine rollout?

Lets say someone has diabetes but isnt over age 65, doesnt work in an essential industry and doesnt meet any other criteria for moving up North Carolinas vaccine priority list.

That person would be in Group 4 of the states five groups:

Group 1: Healthcare workers, long-term care staff and residents

Group 2: Older adults

Group 3: Frontline essential workers

Group 4: Adults at increased risk of severe illness

Group 5: Everyone else

Asked about North Carolinas plan, Rice said: "That is the policy we are seeking around the country, with Type 1 included with other disease that increase risk of severe illness from COVID."

Possible confusion

While people with both types of diabetes are prioritized in North Carolina, old versions of the health departments website may have given people the wrong impression.

Take for example the departments FAQ page about COVID-19 vaccines. Under the "getting vaccinated" section, the department lists chronic conditions that make someone a higher priority for vaccination.

The page currently lists both types of diabetes as chronic conditions.

However, according to an internet archive, the page excluded Type 1 diabetes from its list of chronic conditions as recently as Feb. 12. The webpage quoted CDC guidance, mentioning only Type 2 diabetes as a chronic condition.

That exclusion may be why some media outlets have mentioned only Type 2 diabetes when reporting on North Carolinas rollout.

North Carolina has tried to follow most CDC recommendations, said SarahLewis Peel, a spokeswoman for the health department. However, Peel said, North Carolina has always intended to prioritize all diabetics for vaccines.

People with both types of diabetes have been prioritized together since the state released its guidance for Group 4 on Jan. 25, she said.

Our ruling

The billboard says "Cooper does not consider Type 1 diabetes an (underlying) health issue!"

North Carolinas vaccine rollout prioritizes people with type 1 diabetes ahead of the general population. So its clear that Cooper, to some degree, considers the disease to be an underlying health issue.

We rate this claim False.

See more here:
How are the CDC, North Carolina treating Type 1 diabetes in the vaccine rollout? - PolitiFact

This article was originally published here

Diabetologia. 2021 Feb 17. doi: 10.1007/s00125-020-05351-w. Online ahead of print.

ABSTRACT

AIMS/HYPOTHESIS: This is an update of the results from the previous report of the CORONADO (Coronavirus SARS-CoV-2 and Diabetes Outcomes) study, which aims to describe the outcomes and prognostic factors in patients with diabetes hospitalised for coronavirus disease-2019 (COVID-19).

METHODS: The CORONADO initiative is a French nationwide multicentre study of patients with diabetes hospitalised for COVID-19 with a 28-day follow-up. The patients were screened after hospital admission from 10 March to 10 April 2020. We mainly focused on hospital discharge and death within 28 days.

RESULTS: We included 2796 participants: 63.7% men, mean age 69.7 13.2 years, median BMI (25th-75th percentile) 28.4 (25.0-32.4) kg/m2. Microvascular and macrovascular diabetic complications were found in 44.2% and 38.6% of participants, respectively. Within 28 days, 1404 (50.2%; 95% CI 48.3%, 52.1%) were discharged from hospital with a median duration of hospital stay of 9 (5-14) days, while 577 participants died (20.6%; 95% CI 19.2%, 22.2%). In multivariable models, younger age, routine metformin therapy and longer symptom duration on admission were positively associated with discharge. History of microvascular complications, anticoagulant routine therapy, dyspnoea on admission, and higher aspartate aminotransferase, white cell count and C-reactive protein levels were associated with a reduced chance of discharge. Factors associated with death within 28 days mirrored those associated with discharge, and also included routine treatment by insulin and statin as deleterious factors.

CONCLUSIONS/INTERPRETATION: In patients with diabetes hospitalised for COVID-19, we established prognostic factors for hospital discharge and death that could help clinicians in this pandemic period.

TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04324736.

PMID:33599800 | DOI:10.1007/s00125-020-05351-w

Link:
Predictors of hospital discharge and mortality in patients with diabetes and COVID-19: updated results from the nationwide CORONADO study - DocWire...

Patients' worries about supplies of insulin, as well as other diabetes medications and devices due to Brexit have not, so far, been born out in reality, but the long-term situation remains uncertain as cross-border movement of goods is set to rise, according to experts.

In particular, Northern Ireland puts a fine point on these concerns with difficulties already apparent at border crossings.

Experts also warn patients against stockpiling medicines and related goods, which would in itself create product shortages not directly related to Brexit border issues.

"In some areas the cure is worse than the disease," cautioned Mark Dayan, MSc, Brexit programme lead at the Nuffield Trust.

At only 7 weeks after the end of Brexit transitional arrangements, it is reasonable to assume that the first few weeks are a relatively artificial reflection of the longer-term status quo around the bidirectional trade between the UK and EU.

Concerns around the supply of devices and medicines including insulin are very real to those whose lives depend on it, but in reality, how valid are they?

Back in 2018 when Brexit negotiations were in full-flow, the scene was set when senior officials expressed concerns around insulin supply. Sir Michael Rawlins, who was chair of the Medicines and Healthcare products Regulatory Agency (MHRA) at the time, told the Pharmaceutical Journal that: "We make no insulin in the UK. We import every drop of it. You can't transport insulin around ordinarily because it must be temperature-controlled."

Then a study of tweets posted in 2019 by people with diabetes reflected that these concerns were rife among patients too. At this point the outcome of Brexit 'no deal' or 'deal' negotiations were unknown.

Recently published in JMIR Diabetes on 27 January, the study investigated patients' views around lots of disease-related issues, but of note, the tweets around diabetes product supplies were particularly poignant.

Insulin supply is a key concern for dependent patients because a lack of the replacement hormone can be fatal. The study found that 9% of tweets featured real worries among diabetes patients relating to insulin availability, whatever the outcome of Brexit negotiations.

Tweets emphasised the desperation and fear of some patients. One wrote: "INSULIN - for most of you it is just a medical term, but it is a lifesaver for me and other type 1 diabetics. Do I buy a big fridge to stockpile to make sure I can live while you #brexiters apply for your new blue passport?"

Another wrote: "Diabetics are not sure if their life-saving insulin will run out.So many medications CANNOT BE STOCKPILED!It's a DEATH THREAT from the government and violates our human right to life. #NotoDeathbyBrexit #DyingforBrexit."

Su Golder, PhD, from the University of York led the Twitter study. "UK-based patients with type 1 diabetes were all very worried and scared about supply," she told Medscape UK in an interview. "We don't know if these concerns were real, but the opinion expressed does show how vulnerable these people feel.

"Because insulin is a life-saving drug that needs storing in the fridge, it can't really be stockpiled," she adds.

Nikki Joule, policy manager at Diabetes UK, lends support but also contextualises these concerns. "The worry is understandable, particularly around insulin because people depend upon it for their lives," she said, but added that, "I think much of the concern expressed by people with diabetes is really anxiety and hasn't been borne out by reality, so far at least, and certainly not above and beyond normal short-term shortages that happen, Brexit or not."

Diabetes UK says it has supported Government calls to suppliers of insulin and other diabetes medicines too, asking them to keep 6 weeks of stockin the UK. "Contingency plans comprised alternative routes into the country, extra stock being held on UK soil, and the Department of Health and Social Care (DHSC) ensured those levels of stock with both medications and device companies," said Nikki Joule.

"In fact, we were aware that some companies had threetimes more stock than a 6-week supply, and so far, to our knowledge at Diabetes UK, supply routes seem to be operating well," she added.

The DHSC was always concerned about insulin given how essential it is for people with type 1 diabetes and others who are dependent on insulin, said Ms Joule, and this concern was not only due to the risk of 'no deal' but also for potential disruption due to restrictions or supply issues around COVID-19. "The same actions and contingency plans around supply would need to be taken whether issues were related to Brexit or COVID."

She also noted that stock problems are unlikely for many diabetes medicines such as metformin or gliclazide, because they are made by a large range of companies in the UK.

The default 'no deal' scenario never came to pass, and the EU-UK Trade and Cooperation Agreement was signed on December 24, 2020.

In an interview with Medscape UK, Mr Dayan explained some of the new processes and challenges underpinning the movement of medicines and devices, including those for diabetes, across borders between the European Union (EU) and UK.

Essentially, concerns prevail around customs and regulatory processes, including medicines' safety alert systems.

Since January 1, 2021, customs processes around the logging of import and exports declarations, as well as new permits and details have been required by hauliers to enable movement between countries.

In terms of diabetes-related products moving into the UK from the EU, the border checks and customs declarations required by UK authorities facilitate a smoother flow of goods into the UK than vice versa.

"Right now, things are relatively under control," said Mr Dayan, adding that companies have some concerns, but this does not seem to have led to more shortages than normal. He pointed out that this reflected several years of work by the DHSC and companies in trying to negotiate the best way forward.

To minimise any difficulties associated with Brexit, the UK has provided various grace periods for products entering the UK from the EU, explains Mr Dayan. "For example, deferral on customs forms for 6 months at the UK border, and a 2-year grace period for regulatory issues. Most relevant are the border-to border easement measures, so the UK is accepting batch testing certificates until 2023."

Some arrangements are more mutually beneficial than others and facilitate trade. "The trade and cooperation agreement that came out on Christmas Eve contains mutual recognition for Good Manufacturing Practice (GMP) for medicines, and EU inspection certificates are still accepted here in the UK," Mr Dayan highlights.

"Unfortunately, many of the easements applied by the UK are not reciprocated by the EU," he pointed out.The safety of medicines databases does raise some concerns, Mr Dayan says. When it left the single market, the UK also left behind its right to submit or receive safety alerts and data from the EU systems for pharmacovigilance (EudraVigilance) or devices (EudaMed). "The danger is that we are, as a result, less well informed about emerging or potential problems with drugs and devices on the market," says Mr Dayan.

Alone, the UK has a smaller population to report safety issues than the EU, and safety issues become more visible with higher patient numbers. However, he points out that reporting systems in the EU and US should mean any safety issues or anomalies are visible but the UK will not necessarily have direct access to these databases. "I'm not overly optimistic about this changing. I'd like to have seen more on this in the trade agreement."

The complex situation in Northern Ireland, which is subject to the Northern Ireland protocol (to overcome the need for a border between the Republic of Ireland, which is still part of the EU, and Northern Ireland, which is no longer part of the EU, there is an arrangement whereby there is effectively a border check down the Irish Sea) is challenging and promises to continue to be so.

"The situation around regulatory switch overs in Northern Ireland is making it far more difficult for companies to move medicines from the mainland,"Mr Dayanremarks.

This will remain a live issue, with Cabinet Office Minister, Michael Gove, recently requesting an extension to the existing grace period beyond April.Mr Dayanhighlights that this reflects genuine concerns around the situation there. "For medicines, Northern Ireland has effectively stayed in the EU, and the movement of medicines from the UK [mainland] faces similar hurdles as shipping them anywhere on the continent. This is certainly an area where there is more risk."

The UK is only 7 weeks into Brexit and many companies gave January a wide berth, avoiding the borders for fear of confusion and delays. As a result, cross-border controls have run relatively smoothly to date. The next few months might paint a different picture with volumes of trade at borders picking up.

With all of the UK's insulin imported from the EU, concerns are not without foundation. Supplies are all sourced from EU-based manufacturing and distribution centres, with the main providers being Sanofi (France), Novo Nordisk (Denmark), and Lilly (various EU locations).

But Mr Dayan explained that despite all the UK's insulin supply being imported, insulin supply from the large pharma companies is less risky than medicines made by smaller firms. "These companies might be less capable of dealing with Brexit-related changes around operating across different markets," he said.

On January 1, when the transition period ended, many companies responded to the anticipated pressures and extra administrative needs of Brexit by avoiding the border altogether. "However, at some point this will recover, and as trade volumes increase it might get more difficult. We need to start thinking about the longer-term, for example, around the introduction of new products and long-term cost implications," he cautions.

People building their own personal stockpiles of medicines is the greatest concern stressed by both Mr Dayan and Ms Joule, and more widely. "It isn't a good idea for patients to stockpile because that will create shortages. If people start stockpiling generally then it could apply to other types of medicines and be a greater problem than the effect of Brexit itself," Mr Dayan says.

Most devices, notably continuous glucose monitors (CGM) and goods such as testing strips and sensors, are largely made and supplied by the EU. Exceptionally, the Abbott FreeStyle Libre is made in the UK, and digital interventions likeLow Carb Programare also produced in the UK.

Supply of testing strips or sensors for CGMs might be more challenging than medications, especially ones that need frequent changes such as sensors that require replacement every 7 days.

In early January, people reported a problem obtaining sensors for a Medtronic pump, Ms Joule said, explaining that it actually turned out the delay was with the delivery firm and related to documentation rather than anything to do with the company directly. "This has been resolved now," she says.

Mr Dayan identifies that a key issue for devices is the validity of the manufacturer's CE mark. For UK firms wishing to export their devices to the EU, they would have needed to switch their CE (ConformitEuropenne) mark to an EU regulator prior to January 1, he said. "A UK regulator would not now be able to grant them a CE mark for export to the EU. These firms also have to work through many new customs and border checks for export to the EU that do not reflect the grace period that the UK is applying."

In theory, there is a UK equivalent of the CE mark known as theUKCA(UK Conformity Assessed) marking, which came into effect on January 1, 2021. It is a novel UK product marking that is used for goods being placed on the market in Great Britain (England, Wales, and Scotland). It is not yet widely used in practice. "It covers most goods which previously required theCE marking," says Mr Dayan. However, he adds, there is a grace period until mid-2023 when the UK will still accept EU-granted CE markings.

At the completion of the grace period, new devices made in the EU will need to obtain a UKCA marking as well as an EU CE mark. "This has the potential to increase costs at many steps," Mr Dayan points out.

Costs are predicted to increase once the grace period has passed and new checks, and a higher volume of checks, will need to be implemented.

Various studies have tried to work out the costs of having a free trade agreement versus being in the single market. One studyshowed a significant 5% increase in costs. "Given the NHS spends around 20 billion annually on medicines, that would require an extra one billion pounds," says Mr Dayan.

However, many medicine prices are resistant to price fluctuations due to a set drug price tariff, and a voluntary scheme that caps medicine costs, he explains."Companies are more likely to decide it is unprofitable to supply the UK anymore."

But insulin is unlikely to be affected, he stressed. "Lack of supply due to cost is unlikely to be an issue for insulin, which is a bulk product the UK is very willing to pay for."

However, for higher profit margin items, or at the other extreme, generic medicines where the profit margin is very low, firms might stop supply and this could lead to shortages, he adds. This happens quite regularly despite Brexit, he explained, and has happened more frequently since the EU referendum, probably due to the fall in the value of the Great British pound, which makes some products less profitable."For generic products, we would probably just pay more for them."

But the biggest concern will not be for medicines already on the market, but for new ones, said Mr Dayan. "The UK might be a lower priority market for new products. This tends to happen with smaller markets compared with the EU or US large markets."

Firms might not invest time and resource in a market that has lower returns. However, noted Mr Dayan, size might not be the only consideration. "I suspect the UK will try to use its regulatory system to remain an attractive place to introduce new medicines," he asserts.

"The MHRA granted approval to the COVID-19 vaccines quickly and the UK might be able to offer accelerated routes as an incentive."

More:
Diabetes Product Supply Is This the Calm Before Storm Brexit? - Medscape

Feb 15, 2021

Emily KaplanESPN

When the Chicago Blackhawks publicly admitted to a rebuild this past offseason, there was plenty of speculation about whether Chicago's veteran core would want to see it through.

Perhaps we weren't asking the right questions. One month into the 2021 season, the Blackhawks are far more competitive than expected; at 7-5-4, Chicago is in lockstep with the Columbus Blue Jackets for the fourth Central Division playoff spot. And while the youth movement has been a driving force, we should have been asking: Is the veteran core going to expedite this rebuild?

Captain Jonathan Toews remains away from the team with a medical absence, while Brent Seabrook has not played this season, still recovering from a back injury.

However, the two top performers on the Blackhawks -- besides rookie goaltender Kevin Lankinen -- are Stanley Cup stalwarts Patrick Kane, who is third in the league in points with 22 through 16 games, and Duncan Keith, who leads the team in minutes played by a decent margin while still playing elite-level defense. Neither appears to be slowing down anytime soon.

"I feel like my energy levels have never been better, really," Keith said Sunday evening.

2 Related

A quick reminder that Keith is 37 years old. But across sports, we're starting to recalibrate athletic longevity. Though there is still an obsession with youth, especially in hockey, we've been inundated with more and more examples of athletes defying Father Time.

When the Patriots parted with Tom Brady they might have figured he would decline in his 40s -- because quarterbacks typically have -- but that didn't happen. Brady credits his off-field work, the TB12 method, for a lot of his success. Meanwhile, in a season when many expected LeBron James to take it easy thanks to an unprecedented 71-day offseason, the 36-year-old is top 10 in the NBA in minutes played, building a legitimate MVP case. A few years ago, James' business partner, Maverick Carter, said the Lakers star spends about $1.5 million on his body per year.

A few years ago, Keith said he planned to play until he's 45. The defenseman admits he spoke a little capriciously. "I kind of just said that because I was sick of the media asking," he said. "It started a few years ago when I was 34 or 35. For me, I felt like I was young, I didn't know why I was being asked these questions. At 37 now, I look around and I'm the oldest guy on the team and there's not a whole lot of guys my age [in the league] anymore."

Asked if he could play to 50, Keith laughed. "I don't know if I'll go that far," he said. "But I feel really good right now."

Ask anyone who has played with Keith and they'll tell you he's obsessive about his off-ice regimen. Many young players try to absorb the lessons, while others are just in awe.

"My first year, I was really impressed to learn how much work [Keith] does off the ice, especially when it comes to recovery," Kirby Dach told me last year. "He puts so much work in you don't see behind closed doors."

In 2019, The New York Times wrote an article about Keith's routine in which he called himself a "biohacker and part-time hockey player." Keith said he lies on a mat with electric currents for eight minutes every morning, and routinely spends time in front of Joovv lights, which are designed to help with recovery.

"I've always been diligent about my training," Keith says, now. "But now I feel like I put it all together. I've learned a lot over the years of what my body specifically needs."

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Since Keith debuted in 2005-06, only Ryan Suter has played more minutes than his 28,839. Perhaps most impressive is Keith's consistency. As a rookie he led the Blackhawks in ice time with over 23 minutes per game. Sixteen years later, he's still leading the team, averaging over 24 minutes per contest.

Keith said the aspect of his routine that has changed the most as a pro is his nutrition. "I always thought my eating habits were pretty good," he said. "But now I'm at a point where I'm really dialed in, and I know how to get my energy levels up if they were down through healthy, nutritious foods I put in my body, knowing what my body responds well to."

And for Keith, the answer is not always complicated. "I eat a lot of steak, a lot of meat, and potatoes," he said.

Beyond nutrition, he's constantly thinking about his energy levels.

"I think in general, I've had more awareness to what takes energy away from myself," Keith said. "Whether that's staying up late, staring at my phone, looking at the screen on a TV or computer. I don't think it's necessarily one little gadget that helps me. They've got Normatec boots that help with lymphatic drainage, which is good. There's lots of those types of little things out there you can do and spend money on, but I feel it's always really important to master the basics, which nobody really can -- or anyone that I've met has. That's your sleep, your food, your hydration and your breathing. So I focus on those and it branches out after that."

Of course, we've heard countless athletes talk about sleep, nutrition and hydration, but breathing is discussed far less often.

"It's very underrated," Keith said. "There should be more talk about that. Breathing, and the power of the brain, are two things in hockey or sports, that don't get enough attention. I don't know why that is. The muscles and aesthetics get mentioned -- everyone wants to look good -- and that's important, for sure. There's meditation breathing to bring your nervous system down to more of a parasympathetic state, where you're relaxing, and you're able to recover and rest. But for me, I work on my breathing and the mechanics of it a lot. I actually really started getting into proper breathing eight years ago, and have taken it to the next level in the last year especially. So that's something I'll continue working on."

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Entering the 2021 season, Keith wasn't quite as daunted by the team's approach as some Blackhawks fans might have been. "My mindset didn't really change, because it feels like this has been going on for a while now," Keith said. "As a player, going through the ups and downs of the season each day, wins and losses, the rebuild isn't just starting this season. I just think the organization is trying to be a little more transparent with people. Some of these young guys that come in are excited to play NHL hockey and be in the NHL, and it's invigorating to be part of that type of energy."

This gives Keith an opportunity to be transparent about his own situation. Because he's still contributing at an elite level, and playing on a bargain of a contract for his services -- he's on the tail end of a 13-year contract, which pays him $5,538,462 annually through 2022-23 -- many have assumed Keith might waive his no-trade clause to play for a contender. But Keith emphatically says he has no intention of doing that.

"Why would I go anywhere?" Keith said. "Where is it better than Chicago? It's a great city, I've been fortunate to play here my whole career, great ownership, and I just love it. My goal is to win another Stanley Cup in Chicago. That's what I want."

Jump ahead:Three stars of the weekWhat we liked this weekWhat we didn't likeBest games on tapSocial post of the week

1. A group of 27 student-athletes, coaches and administrators announced the formation of a group called College Hockey for Diversity, Equity & Inclusion this week.

"It's a group of people that wanted to get together and actually make a change in hockey," says University of Alabama Huntsville freshman Ayodele Adeniye, who is part of the coalition. "Our saying is, 'One shift at a time.' Because it might not be the biggest change at a time, but we're just trying to enact change in some way at all times."

Adeniye himself has an interesting story. He was born in 1999 in Ohio, one year before the Blue Jackets debuted, so he grew up amid the area's participation spike, fostered by the Blue Jackets. Adeniye began playing through the NHL's local Hockey Is For Everyone program, the Columbus Ice Hockey Club. "Up until I was around 6 or 7, I was playing with a majority of Black kids," he said. "But as I started going from lower-level hockey and working my way up to higher levels, I started to be the only one."

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College hockey, Adeniye explains, is not extremely diverse. "I have one teammate [Peyton Francis] who is African-Jamaican-Canadian," Adeniye says. "But other than him, I have not seen another Black kid in our league. I saw one other player of color this year, when we played [Robert Morris University]. I'm actually in a group on Instagram of all the Black kids playing in NCAA hockey, and I think there are 15 or 16 of us total."

Adeniye chose UAH in part because his parents moved to Alabama when he was 16. UAH is the only Division I program in a southern state. "My mom hasn't really been able to see me play a lot since I was 16," he said. "So I knew I would be closer to her, and the fam."

When he heard about the formation of the College Hockey for Diversity, Equity & Inclusion group, it piqued his interest. Adeniye reached out to a reporter he knew who had a phone number for Jennifer Flowers, the WCHA women's league commissioner who was organizing the group. "I reached out to her, then told my coach I wanted to be a part of it, and they accepted me," he said.

The group meets on Sundays, via Zoom, and so far is focusing on its "first shift." Members have been sending each other resources they find online focusing on systemic racism. Their first goal is to put together an instructional video that can be played in every college hockey locker room ahead of next season. Adeniye has his own ideas, too.

"There isn't a whole lot of grassroots hockey in Alabama," Adeniye says. "There's not a lot of hockey programs down there, and we definitely don't have any diversity programs or anything like that down here. So once COVID is over, I'm hoping to get into the inner city, and places where there hasn't traditionally been hockey here, and spread the game. I already have a couple teammates that want to support me. I'm going to call it African Floor Hockey Fanatics, and we'll go to Boys & Girls Clubs around here and teach them how to play ball hockey, give them tickets to games, and spread hockey all over Huntsville and the South, which will make it a more inclusive game."

2. It's been a while since the best women's players in the world -- Marie-Philip Poulin, Shannon Szabados, Hilary Knight, Kendall Coyne-Schofield, Brianna Decker -- have had a stage to perform. We'll start to see them showcased in PWHPA games, beginning Feb. 27 at Madison Square Garden, but the event everyone is circling is April's IIHF Women's World Championship in Nova Scotia (which gets a second chance at hosting after the 2020 tournament was canceled).

Players I've talked to are cautiously optimistic the world championships will go on this year -- especially since the IIHF and Hockey Canada were able to stage a world junior championships in December, in a bubble in Edmonton. However, we haven't heard much about the women's senior tournament, at all. I heard that Hockey Canada asked the IIHF to move the tournament back until May, and the sides might push it back as far as August. I asked Hockey Canada for an update last week. In a statement, the organization said it is in constant communication with IIHF as well as the province of Nova Scotia.

"At present time, hosting the 2021 IIHF Women's World Championship in Halifax and Truro, N.S., on behalf of the International Ice Hockey Federation (IIHF) remains a priority for Hockey Canada," the statement said. "All our hockey, venue and event partners remain committed to finding a solution to host a successful world championship."

So, stay tuned ...

1. Cam Atkinson, RW, Columbus Blue Jackets

After a down 2019-20, Atkinson looks to have rediscovered his scoring touch. The Blue Jackets veteran had three goals and four assists in three games this week. Atkinson now has three short-handed goals on the season, and 15 shorties for his career, which is now the most in Columbus franchise history (passing Rick Nash's 14).

2. Mike Smith, G, Edmonton Oilers

He missed the first month of the season on long-term injured reserve, and some fans weren't pleased that the Oilers decided to bring back the 38-year-old (instead of finding an upgrade this offseason). But Smith was a stabilizing force for Edmonton this week, stopping 65 of 66 shots over two appearances (.985 save percentage), including a shutout against Montreal.

3. Marc-Andre Fleury, G, Vegas Golden Knights

The Golden Knights are 8-1-1 at home this season, and Fleury has been a big part of that success. A 30-save shutout on Sunday (the 63rd of his career) meant he stopped 100 of 106 shots over four games this week (.943 save percentage), three of which were wins.

1. Boston Bruins goalie Tuukka Rask is one of the best personalities in the game. He doesn't take himself too seriously. He has human moments, and is happy to talk about them. And that's exactly what happened Wednesday night when Rask left the Bruins' net with one minute remaining in a tied game.

"I honestly thought we were down 2-1," Rask admitted afterward. "That's it. I thought we were down 2-1. I was waiting for [coach Bruce Cassidy] to wave me over there. I'm like why the heck is he not? ... Then I think Chucky [Charlie McAvoy] told me, 'Buddy it's 2-2.' So ..."

Luckily the Bruins made it out of the jam unscathed, and won thanks to Brad Marchand's overtime winner.

"It's an entertainment industry I guess," Rask said. "That's what we're trying to provide, entertainment for the fans. I'm sure people were shocked at first, but hopefully they got a good laugh out of that. I sure did."

2. Speaking of Fleury, here's the best save I've seen this year:

3. The Los Angeles Kings recognized Black History Month on Tuesday with all players wearing warm-up jerseys featuring either Willie O'Ree's or Blake Bolden's name. This is exactly what allyship looks like, and it was cool to see how moving the gesture was for the 29-year-old Bolden, who works for the Kings and is the NHL's first Black female scout.

1. While I know new Pittsburgh president of hockey ops Brian Burke and GM Ron Hextall are well-known hockey men with experience running NHL teams -- something the Pittsburgh Penguins coveted, given their urgency to maximize the end of the Sidney Crosby era -- you have to ask yourself: Are there really only 40 people qualified for these types of jobs, and at what point do we stop cycling through them? Again, not a total slight to the Penguins here, what they did is just emblematic of hockey's hiring practices.

Last year, NHL coaching agent Neil Glasberg -- a champion for diversifying front offices, including the consideration of more European candidates -- called this the NHL's groupthink problem. We've talked about it in relation to coaches, but it's just as bad with management positions.

"The easiest way to frame it is an unwillingness to consider -- let alone listen -- to anybody who isn't widely known by the hiring manager, whether it's the GM, the [assistant] GM, owner, or whoever is running the search," Glasberg said. "Which I think is selling themselves short. Why wouldn't you want to talk to as many qualified people as possible? Instead, most NHL teams have this 'hire-a-friend' mentality. I hear this from my guys all the time: 'It's not the best candidate that gets hired. It's the candidate with the best network or who is the best known.' That's not how you build success. No company would ever be successful if they were just hiring people they knew."

2. Greg Wyshynski and I will have much more on the NHL's plans to finish the season later this week, but it's of note that we're only a month in, and the NHL has already had to adjust its safety protocols twice -- clamping down on player movements each time. In the latest edict, sent to teams this week, it is "strongly recommended" that members of players' households limit their activities as much as possible. Players, meanwhile, will be required to remain at home unless they are attending practices and games, exercising outdoors, performing essential activities (such as going to the doctor), or dealing with family or other emergencies.

There's still optimism that the season can be completed in its current format, and sources on both the NHL and NHLPA sides stressed that they're willing to tweak protocols as many times as needed to adapt. There haven't been any meaningful conversations about returning to a bubble -- and we know how players feel about the bubble, so it would be a hard sell -- but it's alarming that we're in a situation where some teams (like the Vancouver Canucks, who have competed in 18 games) have played double the amount as other teams (the New Jersey Devils have completed just nine games).

That's why everyone you talk to around the NHL stresses one thing: Pay attention to points percentage. All teams might not get to 56 games, but it will be essential for every division to hit approximately the same number of games.

Note: All times Eastern.

Monday, Feb. 15: St. Louis Blues vs Arizona Coyotes, 4 p.m.

It all comes down to this: In an unprecedented seven straight games featuring the same opponents, Monday marks the pivotal Game 7. The Yotes came out strong, but the banged-up Blues won the past two. Aggregate goals are 20-19, St. Louis. Both teams are looking forward to a break from each other after this.

Friday, Feb. 19: Edmonton Oilers at Calgary Flames, 9 p.m. (ESPN+)

Despite this being an entire season built around rivalry games, every contest in the Battle of Alberta feels like appointment viewing. Both teams are still trying to find their stride, with Edmonton putting veteran James Neal on waivers over the weekend (to be put on the taxi squad for cap flexibility).

Saturday, Feb. 20: Vegas Golden Knights at Colorado Avalanche, 3 p.m.

The NHL's first of a two-game set in Lake Tahoe will feature these two Western powers. Get excited for a stunning backdrop -- the rink was built on a golf course next to the lake -- plenty of panoramic views and some playoff-level intensity (it will be the third time these teams play this week). Luckily for Colorado, star Nathan MacKinnon is back after being sidelined three weeks with a lower-body injury.

Chirping doesn't stop once you hang up the skates. Classic troll job from Kevin Bieksa here:

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