By

MATTHEW PERRONE AP Health Writer

May 29, 2020, 7:30 PM

2 min read

2 min read

WASHINGTON -- U.S. health regulators are telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory tests found elevated levels of a contaminant linked to cancer.

The Food and Drug Administration said late Thursday that several batches of the drug metformin tested positive for unsafe levels of a chemical called N-Nitrosodimethylamine. The agency has stepped up testing after the chemical was found in dozens of shipments of heartburn drugs last year, triggering recalls of Zantac and other popular over-the-counter and prescription medications.

Metformin tablets are a staple of diabetes care, reducing excess sugar in the blood. People with Type 2 diabetes use metformin alone or with other drugs to help control their blood sugar levels. More than 34 million people in the U.S. have this disease.

Patients should continue taking metformin drugs until their doctor can prescribe a replacement, the FDA said in a statement, noting the risks of discontinuing. Regulators are still assessing whether the recalls will lead to shortages of metformin, but noted that a number of other companies make generic versions of the drugs that don't appear to be affected by the issue.

Drugmaker Apotex Corp. recalled its extended-release metformin distributed in the U.S. earlier this week after the FDA found contamination in one lot. Apotex said in a statement it recalled all supplies of the drug out of an abundance of caution. The company said it stopped selling the drug in the U.S. in February 2019 and that little remains on the market.

The FDA announcement did not name the four other drugmakers who have been requested to recall their products.

The agency noted that no contamination problems have been found in immediate-release metformin.

The FDA is responsible for ensuring that medicines for the U.S. market are made in safe, sanitary conditions that meet federal quality standards. But government inspectors have repeatedly criticized the agency for falling short in reviewing overseas manufacturing plants as the pharmaceutical supply chain has increasingly spread to Asia.

In March, the FDA suspended nearly all U.S. and foreign inspections due to safety concerns and travel restrictions caused by the coronavirus outbreak.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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FDA finds contamination in several brands of diabetes drug - ABC News

New research has found that eating dairy foods appears to be linked to a lower risk of diabetes and high blood pressure. An international team of researchers studied 147,812 participants aged between 35 and 70 from 21 countries: Argentina, Bangladesh, Brazil, Canada, Chile, China, Colombia, India, Iran, Malaysia, Palestine, Pakistan; Philippines, Poland, South Africa, Saudi Arabia, Sweden, Tanzania, Turkey, United Arab Emirates and Zimbabwe.

The participants completed Food Frequency Questionnaires which assessed how they ate over the last 12 months. Dairy products included milk, yogurt, yogurt drinks, cheese and dishes prepared with dairy foods, which were classified as full or low fat (1 to 2%). Butter and cream were analyzed separately because they are not commonly eaten in some of the countries in the study.

Other factors such as the participants medical history, use of prescription medicines, smoking status, measurements of weight, height, waist circumference, blood pressure and fasting blood glucose were also recorded. Participants were followed for an average of nine years.

The results showed that eating at least two servings of dairy each day is linked to an 11 to 12% lower risk of diabetes and high blood pressure, while three servings of total dairy each day are linked to a 13 to 14% lower risk. The associations were stronger for full-fat dairy than they were for low-fat dairy.

Two daily servings of total dairy were also linked to a 24% lower risk of metabolic syndrome, which is a collection of conditions that includes a higher waist circumference, high triglyceride levels, low levels of good cholesterol, hypertension (high blood pressure) and high fasting blood sugar, which together can increase the risk of cardiovascular disease. The relationship also was stronger for full-fat dairy; two servings of full fat were linked with a 28% lower risk of metabolic syndrome, compared with those who ate no dairy foods, and eating low-fat dairy was not associated with a lower prevalence of most of the conditions that make up metabolic syndrome.

The study is observational, so it does not prove a cause and effect relationship. However, if the findings are confirmed in sufficiently large and long-term trials, then eating more dairy foods may be an easy and inexpensive way to reduce metabolic syndrome, hypertension, diabetes and ultimately cardiovascular disease.

The rest is here:
Extension notes: Eating dairy foods may lower the risk of diabetes and high blood pressure - The Herald Journal

FOX 2 - A Taylor woman's life has been changed forever because of COVID-19 and now she is in dire need of help. She will need to be moved to an acute rehab facility but not many are willing to take here because she had the virus.

"It is a lot, it is really overwhelming," said Wanavia Wilson. "Some nights I just cried all night, I didn't know what to do."

A Taylor woman's life has been changed forever because of COVID-19 and now she is in dire need of help.

Wanavia Wilson has been by her daughter's side since mid-May. Shantel Wilson, a 25-year-old mother of two small children, suffers from Type 1 diabetes. On May 12th she went to sleep and her blood sugar dropped to dangerous levels.

"When she is awake she notices the symptoms, the shakiness, the dizziness and she'll go and tested herself and eat something if it is low, because she was sleeping when it happened. She just kept sleeping and never woke up. (She was in a coma) for four days."

Doctors told her mother that Shantel suffered severe brain damage. Although she didn't have any symptoms, a routine test also revealed Shantel had COVID-19, which may have caused her blood to drop. She is now at Beaumont Farmington.

"She needs neurological therapies, speech therapy, physical therapy and occupational therapy," Wanavia said. "Because her sugar was low for an undetermined amount of time, they said they said going that long caused significant damage to both sides of her brain and it affecting her speech and her behaviors. So right now, she is basically a child again."

Shantel will need to be moved to an acute rehab facility, but her mother says because she had coronavirus - no facility has been willing to take her.

"Things were starting to pick up for her," her mother said. "I was so happy and so proud of her when she bought her first house. I was so proud of her when she got her degree, and I was like things are going so well for you and then (this)."

Wanavia has been off work because of the pandemic and has been doing what she can to scrape enough money together to care for Shantel's young son and prepare her home to care for her daughter, who won't be able to do anything for herself.

She has started a GoFundMe page to help offset some of the costs. Wanavia knows so many people are struggling right now, but says anything would be appreciated.

"As a parent you want the best for your kids and it is just hard when you see your kid struggling," she said. "She is very stubborn, very smart, very hard working. I am hoping and praying that thing about her that makes her so stubborn and such a fighter., will help her get past this."

Shantel said her first words today. If you would like to contribute, GO HERE.

Continued here:
Mother of 2 with diabetes gets coronavirus and is left with brain damage - FOX 2 Detroit

By: Lifestyle Desk | New Delhi | Updated: May 29, 2020 11:34:08 am It is the need of the hour to keep the sugar levels in check for the ones with diabetes as the cases of Covid-19 is increasing speedingly. (Source: Getty/Thinkstock/Pixabay images)

If one gets diabetes, not only does their blood sugar level get affected, but the insulin production level also gets compromised. People with high or unmanaged blood sugar levels tend to have less than normal blood flow, because of which the body finds it difficult to harness nutrients and heal. Thus, due to the weakened immune system, people suffering from diabetes are prone to infections, and may take a longer time to get back on track. The condition, however, is manageable, even in the wake of coronavirus.

It is the need of the hour to keep the sugar levels in check for the ones with diabetes as the cases of Covid-19 increase stupendously.

* Stay hydrated, and eat fresh fruits and vegetables to enhance your immunity.

* Exercise on a daily basis. Try to increase activities at home. Do exercises that will not stress you out. Opt for yoga, pranayama, and deep breathing exercises. This will improve your pulmonary function and will not cause any disturbance in breathing. Even light stretches can be done to keep your body supple and fit. You can also do simple household chores such as sweeping, mopping, and cleaning, suggests Dr Anil Boraskar, Diabetologist, ACI Cumballa Hill Hospital, Mumbai.

* Check blood sugar level at home with the help of home glucose monitoring that is reliable machines. You can check your blood sugar levels and keep a target of less than 140 and 180 mg/dl. If your sugar is in this range then monitor the levels, every alternate day. If your sugar levels are not in this range then monitor it thrice a day, and you will have to take insulin instead of medications. Consult your diabetologist over the phone, who will set your insulin doses according to your blood sugar levels.

* If you are diabetic and hypertensive, then monitor your blood pressure levels from time to time and take medications.

* Washing hands is important, and so is washing feet. Clean them regularly. You can take the help of your family members and look for any cuts, ulcers, or wounds on the feet. Get immediate attention if required.

* Maintain good personal hygiene. Upgrade your skin, oral, and intimate hygiene. Practice social distancing.

* The spread of COVID-19 is via asymptomatic patients in whom symptoms are not seen. But if you are a diabetic and have a seasonal cough or cold then pay attention to it. Other symptoms that people with diabetes may have is hypoglycemia (can be described as a condition in which your blood sugar (glucose) level is lower than normal). This can be dangerous so help yourself with sugar if your sugar is less than 70 mg/dL. Make a note of what has caused a drop in your sugar level, says Dr Boraskar, Diabetologist.

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Tips for diabetes patients to manage their blood sugar - The Indian Express

One of the challenges of managing diabetic retinopathy is the numerous intricacies and nuances in its presentation outside of classic textbook.

Case reportA 52-year-old African-American male with type 1 diabetes had been referred 5 years earlier for proliferative diabetic retinopathy (PDR, Figure 1) and had undergone treatment, including multiple intravitreal anti-VEFG (vascular endothelial growth factor) injections in both eyes and panretinal photocoagulation initially in both eyes (Figure 2).

Those procedures were followed by pars plana vitrectomy (PPV) in the right eye as the result of progression of tractional retinal detachment involving his macula (Figure 3).

He did not have direct vitreomacular traction in the left eye as he was demonstrating a progressive increase in his central foveal thickness and enlarging intraretinal cystic spaces (Figure 4) while reporting progressive loss of his vision.

These findings were initially thought to be the result of diabetic macular leakage, but they were not responding to conventional anti-VEGF injections. A fluorescein angiography (FA) was performed to identify the source of this possible leakage. Although the FA showed leakage of active neovascularization elsewhere (NVE) and diffuse macular leakage in the right eye, there was no macular leakage in the left eye and mild leakage of an old patch of neovascularization of the disc (NVD, Figure 5)

This was contrary to the optical coherence tomography (OCT) findings that were showing the presence of epimacular (also called epiretinal) membrane (EMM) in the right eye and the cystic spaced left eye (Figure 6).

An alternative wide-field OCT (55) was performed to assess the vitreoretinal interface and the retinal thickness beyond the conventional central 30 scan. The results were remarkable, showing that tractional forces and tractional retinal detachment (TRD) extending from the disc toward the nasal retina was responsible for the macular appearance (Figure 7).

This pulling force is similar to dragging a rope tangentially to raise a sail. The patient underwent PPV and repair of the TRD. Following this procedure, the resolution of traction resulted in significant reduction of the schisis cavities in extramacular retina (Figure 8). Macular schisis, although improved, will take several months to slowly subside.

DiscussionIt is easy for clinicians to become accustomed to the routine and become complacent in practice methods. However, when unconventional and unexpected presentations arrive, clinicians need to step outside of the box and think of alternatives that help in managing patients and improving their quality of life.

Eyecare practitioners have incredible technology such as ultra widefield fundus imaging and spectral domain OCT at their disposal; however, they dont always use them to their maximum capabilities.

Related: Patient perception of good vision a trap leading to loss

Link:
Know the many facets of diabetic retinopathy - Optometry Times

Two thirds (67 per cent) of people with diabetes attending work do not feel safe, according to a new survey carried out among those with the condition.

More than half of respondents (54 per cent) to the Diabetes UK poll also say their employer is not enabling them to socially distance at work.

Since the lockdown started, the charity has seen unprecedented demand from people with diabetes seeking support on issues relating to employment and coronavirus through its helpline and support services.

The survey of almost 3,000 people with diabetes, revealed that almost half (45 per cent) of the people who are either currently at work, or are soon due to be returning to work outside of the home, reported not feeling confident in raising concerns about social distancing or safety at work with their employer.

The 3.9 million people diagnosed with diabetes in the UK are identified in the Governments list of clinically vulnerable groups, and the current advice is that people with diabetes should follow social distancing measures stringently, stay at home as much as possible, and minimise contact with those they do not live with.

A return to business as usual is not possible for people with diabetes, because of the lack of adequate safeguards from Government to ensure their safety Chris Askew

The new research also revealed that more than half of those working outside of home (57 per cent) do not know where they can get support from to resolve workplace safety issues.

A key element of the Governments recent employment guidance to protect workers, was the need for employers to carry out risk assessments for their employees, and make provisions to mitigate risk where it existed.

However Diabetes UKs survey found that this does not seem to be working in practice, as of those due to return to work, 60 per cent have not been consulted about a risk assessment that had been, or was in the process of being carried out, despite being in a clinically vulnerable group.

Diabetes UK does not believe the Governments employment guidance goes far enough to ensure safety at work for people with diabetes and those in other clinically vulnerable groups who are at increased risk of serious illness or death if they catch Coronavirus.

The charity is urgently calling for additional measures to ensure the safety of clinically vulnerable people at work.

Diabetes UKs Chief Executive Chris Askew said: A return to business as usual is not possible for people with diabetes, because of the lack of adequate safeguards from Government to ensure their safety.

With the new evidence on the increased risk for people with diabetes regarding COVID-19 Government must act now and review all the current guidelines and measures to keep people with diabetes and other clinically vulnerable groups safe. If lockdown continues to ease without specific and enforceable safeguards for people in clinically vulnerable groups in place, this pressure will only intensify further.

People with diabetes deserve to have their individual needs fully considered, with action taken to reduce any risk of coming into contact with the virus. A generic and catch-all assessment of workplace risks by employers does not go far enough and this evidence shows is not working in practice for people with diabetes.

The Government must ensure that employers take all the necessary measures to keep all employees safe, now and going forward if they are expected to attend work outside the home this includes clinically vulnerable people having a right to stay working from home if they do not feel safe.

Diabetes UK has written an open letter to the Secretary of State for Business, Energy and Industrial Strategy, urgently calling for more robust protections for clinically vulnerable workers and greater clarity for both employees and employers. The organisation is specifically calling for:

Photo by Ketut SubiyantofromPexels

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Two thirds of those with diabetes do not feel safe at work - The Diabetes Times

Shalini Sharad, Ascensia Diabetes Care, looks at how harnessing digital health solutions can help combat the rise in type 2 diabetes.

Diabetes affects 425 million people globally and this number continues to grow each year, as shown by figures from the International Diabetes Federation. This increase is largely due to the growing number of people with type 2 diabetes.

As demographic and lifestyle factors put ever more people at risk of developing this condition, the need for personalised, tailored support for those with type diabetes is becoming more important. It is also vital to note that no two cases of type 2 diabetes are the same, and treatment options need to remain varied. However, with restricted healthcare resources and physicians having limited time to spend with each patient, it is increasingly obvious that traditional methods may fall short of offering personalised management.

Opportunities to improve the experiences of people with diabetes (PWDs) and how they manage their diabetes are evolving, thanks to advances in digital technology. Digital monitoring devices and apps are providing more flexibility in how diabetes is managed and can improve access to care by making it easier for PWDs to access management advice. This is good for PWDs, clinicians, healthcare systems and society by helping to manage the rising burden of diabetes more effectively and efficiently.

Data and diabetes

The major advantage of digital solutions in diabetes is their ability to seamlessly capture and interpret data, and digital solutions are now being developed in all aspects of diabetes management. Novo Nordisk is currently working on its first connected insulin pens, NovoPen 6 and NovoPen Echo Plus, which are expected to reach the market later this year. These pens are designed to automate the capture of insulin dosing data by connecting to smartphones. By adding in a connected blood glucose meter or continuous glucose monitor, they can bridge the gap between glucose and insulin data. However, the bigger potential for digital diabetes solutions is in helping to manage type 2 diabetes.

The usage of digital solutions for diabetes management has seen an exponential increase over the years and this is set to continue. A 2018 report forecasted that in 2022 there will be 23.5 million people using diabetes apps worldwide, which contrasts to 6.1 million in 2017. But technology alone is not enough. For the full benefits of digitisation to be harnessed by healthcare systems and PWDs, there needs to be greater collaboration between payers, providers, and Healthcare Professionals (HCPs). A truly joined up approach to diabetes is something that we should all strive for, but only by working together will we be able to deliver the care that PWDs need - and we are not there yet.

In order to positively impact peoples health, digital solutions need to be implemented as part of a comprehensive ecosystem, one that factors in all aspects of life that may affect a persons experience with diabetes, from medication, to diet, to mental health. Adding meters and apps to an already complex landscape of diabetes management can confuse both PWDs and HCPs, and this needs to be managed, along with minimising the effort required from PWDs to integrate digital health solutions into their lives. Diabetes already comes with a long list of diabetes relates tasks and considerations, and additional management tools should seek to simplify and not complicate.

Interconnected diabetes management (IDM) focuses on treatment beyond the pill. By providing people with much-needed guidance alongside a simplified, holistic management tool, it harnesses digital solutions to bring together multiple aspects of diabetes management which are currently managed in silos.

IDM also aims to improve collaboration with healthcare systems and others involved in a persons diabetes care, in order to improve outcomes. Health2Sync is one such solution that captures data and makes it available to those involved in a persons diabetes management. The app enables people to easily log blood glucose, blood pressure, weight and daily activities, and allows them to share this information with family members and HCPs. It also helps to provide customised recommendations and reminders, based on the data collected. And there is growing data to suggest that this holistic digital management approach can improve outcomes in type 2 diabetes.

Ascensia solution

Ascensia Diabetes Care has shown clinically meaningful results from the use of IDM and demonstrated how such a solution has the potential to improve type 2 diabetes management. A study found that using an investigational IDM solution decreased HbA1c levels of 0.43% in people with type 2 diabetes over 12 weeks, independent of any changes to medication. This suggests that IDM solutions could lead to better glycemic control through an improvement in self-care.

The Ascensia solution combines remote behavioural coaching and a mobile application to collect, store, and analyze key data about a persons health from a variety of sources, which in my opinion represents the ideal digital solution for type 2 diabetes. The coaching needs to be based on the data that is gathered by the app to offer tailored guidance, providing PWDs with actionable information in support of their individual self-management.

The use of digital coaching for diabetes is estimated to increase from 240,000 users in 2017 to 3.8 million by 2022, but the type of coaching is also an important consideration. Coaching should be provided by a combination of human-based and machine-based systems, in order to efficiently manage large populations of people with type 2 diabetes. For example, machine-based support can be used to provide simple recommendations based on analysed data, while regular interactions with trained staff, such as diabetes educators, can provide the more specific coaching for people to make positive behavioural changes in areas such as glucose monitoring, food choices, activity levels, stress, and sleep. The contributing factors to diabetes management outcomes are varied. Ascensias study assessed 25 impactful behaviours which could be addressed by the IDM solution it is currently developing.

Behavioural changes, education, more frequent readings, as well as a feeling of being supported leads to PWDs enjoying a healthier and better quality of life, at whatever stage of their diabetes journey they may be. It can help to improve outcomes and studies are starting to show that it can lead to better managed diabetes.

Additionally, the interaction between a patient and a CDE through a digital solution provides access to valuable guidance when visits to HCPs can be infrequent. By educating users remotely and providing tools to track progress, PWDs are still supported whilst payer costs and burden on the healthcare system are reduced. In fact, the total cost of diagnosed diabetes rose by 26% between 2012 and 2017, with costs in the US at $327 billion in 2018.

HCPs, payers, and healthcare systems are increasingly calling for bundled services. Simply offering a patient a drug and glucose monitoring device is no longer enough, with those involved now looking for each aspect of diabetes management to be carefully considered and interconnected in a holistic solution; with a view to improve patient outcomes.

We are just at the start of the digitisation of diabetes management, but we are making progress. Digital solutions are already beginning to demonstrate their benefits, with 52% of those using a health or wellness app to manage their diabetes seeing positive results. Increasing that figure will require more seamless integration of IDM and digital health solutions into every-day diabetes care.

By taking a more holistic approach to digital management in type 2 diabetes, we can reduce the impact of diabetes on society and healthcare systems, and improve the lives of PWDs everywhere.

Link:
Diabetes and the role of digital health - Med-Tech Innovation