Category Archives: Diabetes

LONDON, ONTARIO - TheNewswire - June 18, 2020 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical-stage regenerative medicine therapeutics company, highlights positive results from its submitted abstract entitled "Clinical Validation of the Implanted Pre-Vascularized Cell Pouch(TM) as a Viable, Safe Site for Diabetes Cell Therapy," selected for presentation at the American Diabetes Association's (ADA) 80th Scientific Sessions held virtually June 12-16, 2020.

"Sernova was honored that its abstract was selected under peer review to be presented at the prestigious ADA Scientific Sessions. The findings reported in diabetic patients, demonstrate that human donor islets transplanted into Sernova's Cell Pouch consistently demonstrate islet survival and the ability to produce the array of hormones required to treat diabetes," said Dr. Philip Toleikis, President and CEO of Sernova.

The following provides the background of our scientific presentation:

- Cellular transplantation therapy has the potential to treat severe, chronic diseases such as Type 1 Diabetes (T1D). The transplantation site and device approach are major factors influencing successful clinical outcomes;

- With new cell-based emerging technologies, there continues to be a need to find a safe, retrievable, biologically compatible device for cellular transplantation and we believe Sernova's Cell Pouch System may provide such a solution;

- The transplantation of insulin-producing islets is a cellular replacement therapy for severe T1D in patients who experience life-threatening severe hypoglycemia unawareness events;

- In this clinical indication, Sernova has conducted a physician sponsored first-in-human study in Canada and currently has an ongoing company-sponsored Phase I/II human clinical study at the University of Chicago. In both clinical studies, patients with T1D were implanted with both sentinel (small devices removed to assess cell survival) and larger therapeutic devices, anywhere between 1 to 6 months;

- After being placed on immunosuppression, islets were isolated from donor pancreata and transplanted into patients within the device chambers. When possible, a pre-transplant sample of islets was saved for comparison to post-explant Cell Pouch islets; and

- Cell Pouches were explanted from patients, anywhere between 14-90 days post-transplant. The Cell Pouches were prepared, and sections were stained and imaged, and then reviewed by an independent clinical pathologist to assess the transplanted tissue for micro-vessel formation and vascularization; the presence of islets with insulin, C-peptide, and other endocrine hormones (such as glucagon and somatostatin); and exocrine tissue (such as pancreatic ductal tissue).

The data presented clinically demonstrate that the vascularized Cell Pouch provides a consistently safe and biologically suitable, retrievable environment for the transplantation and survival of functional islets. Specific findings based on a detailed histopathological analysis of nine Sernova Cell Pouches explanted from patients with T1D diabetes include:

- Explanted Cell Pouches show abundant, viable, organized islet cells intimately associated with blood vessels within a natural collagen matrix following transplantation without obvious rejection or infection;

- 100% showed present or abundant blood vessels;

- 89% showed present or abundant insulin;

- 78% showed present or abundant endocrine cells;

- 100% showed present or abundant ductal tissue;

- Islet cells required to control diabetes within the Cell Pouches consistently express insulin and other endocrine hormones, such as glucagon, somatostatin, and C-peptide, when identified histologically;

- Pre-transplant islet samples that show strongly expressed insulin, as well as other endocrine markers, were similarly identified in the explanted Cell Pouches following transplant; and

- The amount of islet/exocrine tissue within pre-transplanted samples was similar to that found in the Cell Pouch following transplantation.

In summary, the transplanted samples, when explanted and examined, demonstrate healthy, surviving islets with multiple cell types within the islets capable of producing the hormones that control blood sugar levels when housed in the vascularized tissue matrix of the Cell Pouch. Exocrine ductal tissue, when transplanted, also survived. The findings demonstrate the pre-transplant samples are consistent with the histology observed upon explantation of the Cell Pouch at different time points. These clinical findings demonstrate that the Cell Pouch is a viable, safe site for diabetes cell therapy.

Dr. Toleikis said, "The positive results reported in patients in this diabetes indication, implanted with Sernova's Cell Pouch and transplanted with islets, continue to validate our Cell Pouch System cell therapy therapeutics approach. Within the emerging cell therapy field, Sernova, with its advancing cell therapies including locally immune protected stem cell-derived cells, continues to position itself as a leader in the development of a 'functional cure' for all patients with diabetes and other chronic diseases."

A recording of Sernova's ADA Scientific Session presentation is available at http://www.sernova.com/updates.

ABOUT SERNOVA'S CLINICAL TRIAL

Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial at the University of Chicago to assess the safety and tolerability of islet transplantation into the company's patented Cell Pouch in diabetic subjects with hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures. Patients enrolled in Sernova's clinical trial are incapable of producing c-peptide, a biomarker for insulin produced by islet cells.

Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, are transplanted into the Cell Pouch.

A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision is made with regard to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients are then further followed for one year to assess longer-term safety and efficacy.

For more information on this clinical trial, please visit http://www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details, please visit http://www.pwitkowski.org/sernova.

ABOUT SERNOVA'S CELL POUCH SYSTEM

The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II study at the University of Chicago.

ABOUT SERNOVA CORP.

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit http://www.sernova.com.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Dominic Gray

Sernova Corp.

Tel: (519) 858-5126

dominic.gray@sernova.com

http://www.sernova.com

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute "forward-looking statements" that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management's beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova's actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company's ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company's Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company's quarterly and annual filings available on http://www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Sernova Highlights Positive Results Presented at the American Diabetes Association's Virtual 80th Scientific Sessions - TheNewswire.ca

The global Millimeter Wave Diabetes Treatment Devices market is segregated on the basis of Type as Under 50 GHz and Above 50 GHz. Based on Application the global Millimeter Wave Diabetes Treatment Devices market is segmented in Type 1 Diabetes and Type 2 Diabetes.

FYI, You will get latest updated report as per the COVID-19 Impact on this industry. Our updated reports will now feature detailed analysis that will help you make critical decisions.

The global Millimeter Wave Diabetes Treatment Devices market report scope includes detailed study covering underlying factors influencing the industry trends.

Browse Full Report: https://www.marketresearchengine.com/millimeter-wave-diabetes-treatment-devices-market

The global Millimeter Wave Diabetes Treatment Devices market report provides geographic analysis covering regions, such as North America, Europe, Asia-Pacific, and Rest of the World. The Millimeter Wave Diabetes Treatment Devices market for each region is further segmented for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.

Competitive Rivalry

Zimmer MedizinSysteme, Smiths Group, Domer Laser, Hubei YJT Technology and others are among the major players in the global Millimeter Wave Diabetes Treatment Devices market. The companies are involved in several growth and expansion strategies to gain a competitive advantage. Industry participants also follow value chain integration with business operations in multiple stages of the value chain.

The Millimeter Wave Diabetes Treatment Devices Market has been segmented as below:

Millimeter Wave Diabetes Treatment Devices Market, By Type

Millimeter Wave Diabetes Treatment Devices Market, By Application

Millimeter Wave Diabetes Treatment Devices Market, By Region

Millimeter Wave Diabetes Treatment Devices Market, By Company

The report covers:

Report Scope:

The report covers analysis on regional and country level market dynamics. The scope also covers competitive overview providing company market shares along with company profiles for major revenue contributing companies.

The report scope includes detailed competitive outlook covering market shares and profiles key participants in the global Millimeter Wave Diabetes Treatment Devices market share. Major industry players with significant revenue share include Zimmer MedizinSysteme, Smiths Group, Domer Laser, Hubei YJT Technology, Application C10, Application B10, Application B8, Application B9, Application B10, Application C10, and others.

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Millimeter Wave Diabetes Treatment Devices Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By...

Bone health among those with diabetes could be under threat as new research shows the condition increases the risk of fractures.

A study, carried out by the University of Sheffield, found that people who have either type 1 or type 2 diabetes are at a greater risk of suffering from a hip fracture, or a similar injury.

The risk is larger among those with type 1 diabetes than people with type 2 diabetes, although this largely depends on how long the person has had the condition, researchers said.

Lead researcher Dr Tatiane Vilaca, from the University of Sheffields Mellanby Centre for Bone Research, said: Diabetes can cause a number of well-known complications including kidney problems, loss of eyesight, problems with your feet and nerve damage. However, until now many people with diabetes and their doctors are unaware that they are also at greater risk of bone fractures.

We need to raise awareness about the greater risk people with diabetes face to help them to prevent fractures. For example, preventing falls can reduce their risk of fracture.

Fractures can be very serious, especially in older people. Hip fractures are the most severe as they cause such high disability. Around 76,000 people in the UK suffer a hip fracture every year and it is thought as many as 20 per cent of people will die within a year of the fracture. Many others dont fully regain mobility, and for many people it can cause a loss of independence.

Read more on this topic:

Professor Richard Eastell, Professor of Bone Metabolism and Director of the University of Sheffields Mellanby Centre for Bone Research, said the findings highlights the urgent need for healthcare professionals to focus more on bone health among those with diabetes.

He added: We hope that by raising awareness about the greater risk people with diabetes face, bone density and bone strength will become something that doctors assess routinely in patients with the condition in the same way they do currently for other well-known complications.

The research was a collaboration with the University of California and has been published in the Bone journal.

Dr Steven Cummings, from Sutter Health, California, said: Patients with diabetes and the doctors who care for them should be aware of the increased risk of fractures. Patients are encouraged to ask their doctors what to do about that risk, and doctors should assess the risk and consider treatment to reduce that risk.

Continued here:
People with diabetes at higher risk of bone fractures - Diabetes.co.uk

By Faye Gaston

Good news for Bullock County senior citizens with diabetes on Medicare was announced on Tuesday, May 26, 2020. This new insulin benefit will be available in all fifty states, Washington D.C. and Puerto Rico.

Those whose Medicare drug plans don't offer this new option for 2021 can switch plans during the open enrollment season that starts October 15, 2020.

The new benefit is voluntary. One out of every three senior citizens on Medicare has diabetes, and more than three million use insulin.

Most Medicare recipients will have access to new prescription plans that limit their copay for insulin to no more than $35 a month, saving 66% of insulin cost.

One thousand seven hundred fifty insurance plans that offer drug coverage for Medicare recipients have agreed to provide insulin for a maximum copay of $35 a month. Thirty-four million Americans have diabetes, and seven million need insulin.

The human body should make adequate insulin, but some must depend on taking insulin to live a long and healthy life.

The cost of insulin is one of the biggest worries, with 25% of people with diabetes rationing insulin or skipping doses, which puts their lives in jeopardy. Millions of people use insulin to keep their blood sugars at normal ranges and stave off complications of diabetes, which are heart disease, blindness, kidney failure, and amputations.

A recently added concern is that people with diabetes do worse with the COVID-19 pandemic. The new Medicare prescription drug benefit offered by private insurers (free market) is added to traditional Medicare ("Part D") or under Medicare Advantage to begin in 2021.

These new "stable copays" for insulin (maximum $35 a month) are the result of a deal "shepherded by the Administration between insulin manufacturers and major insurers." This major accomplishment for senior citizens on Medicare was announced by President Trumps' administration in the Rose Garden on Tuesday, May 26, 2020.

Medicare premiums are deducted from Social Security payments each month to senior citizens, and this administration has promised to protect Medicare and Social Security.

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Protecting seniors with diabetes | News | unionspringsherald.com - Union Springs Herald

STRICTLY FOR EUROPEAN MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY

A new expert-led report has today been launched to help outline key challenges and inequalities in the care of type 2 diabetes mellitus (T2DM) and its associated renal and cardiovascular complications, and highlight some Calls to Action to try and address these gaps for the 53 million Europeans living with T2DM.1 A New Era in Diabetes Care is a non-promotional disease awareness initiative that brings together a European Multidisciplinary Steering Committee of diabetes, nephrology and primary care experts, funded by Mundipharma International Limited. The report, authored by the Steering Committee, explores five main areas within the management of T2DM, chronic kidney disease (CKD) and cardiovascular disease (CVD):

"The complications of type 2 diabetes, such as chronic kidney disease and cardiovascular disease, are a huge burden on patients and healthcare systems and with the increasing prevalence of the disease, the situation is expected to get worse. These two complications are directly linked, so by treating and slowing progression of chronic kidney disease, clinicians may also reduce the risk of cardiovascular disease, which is the leading cause of death in these patients," commented Professor David Wheeler, Chair of the A New Era in Diabetes Care Steering Committee, and Professor of Kidney Medicine at University College London, Honorary Consultant Nephrologist at the Royal Free NHS Foundation Trust, London, UK. "This report highlights how critical it is for physicians to screen early for chronic kidney disease, treat appropriately, and regularly review treatment outcomes in their patients, to prevent the development of serious complications."

The Steering Committee also discussed the management of T2DM and its complications through the lens of COVID-19, and agreed that annual screening for CKD should continue to take place while also protecting people with T2DM, by following the relevant shielding guidelines and using telemedicine where appropriate.

Approximately 59 million people in Europe currently live with diabetes, which is set to rise to 67 million by 2045.1 If left untreated, patients are at greater risk of developing serious health complications, such as renal disease and cardiovascular disease, which are the two most common causes of death for T2DM patients.2,3 It is estimated that more than 40% of people with T2DM will develop CKD,4 and nearly a third will develop CVD.2

As part of the A New Era in Diabetes Care initiative, Mundipharma conducted a general public survey of 9,143 adults in eight countries across Europe, which uncovered several gaps in the awareness of T2DM and its links with other systemic complications such as CKD and CVD.5 Nearly half of survey respondents (42%, n=3,840) were unaware there are two main types of diabetes (type I and type 2) and almost all (94%, n=8,594) were unaware that nine out of 10 people with diabetes have T2DM. When asked what they thought were the most serious complications of T2DM, only a third (32%, n=2,926) of respondents chose CKD, and less than half (46%, n=4,206) chose CVD, despite these being two of the main causes of death in this patient population.2,3

Participants were also unsure when it came to the symptoms of CKD, with just 7% (n=640) correctly recognising that in the early stages of CKD, there are usually no symptoms, making it vital to conduct routine screening to diagnose it before it has progressed. In regard to treating CKD, almost half of respondents (43%, n=3,931) were unaware that although incurable, the worsening of the disease can be controlled by appropriate treatment and by managing blood pressure and blood sugar levels. The impact of CKD was also underestimated with only 29% (n=2,651) of people thinking it can have a major impact on someones mental health and less than half (47%, n=4,297) believing it to have a major impact on quality of life.

"The findings of this expert-led report, in addition to the recent survey results, emphasise that in both healthcare settings and amongst the general public, the kidneys are not top of the agenda when it comes to type 2 diabetes mellitus. This report aims to provide primary and secondary healthcare professionals with a structured care plan for patient-focused prevention, monitoring and treatment of chronic kidney disease in type 2 diabetes," said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma.

Story continues

The report can be downloaded here: https://www.dcvd.org/tl_files/download/Bilder/A%20New%20Era%20in%20Diabetes%20Care%20Report.pdf

-END-

Notes to the editors:

About the A New Era in Diabetes Care initiative

In February 2020, a group of eight European primary and secondary care healthcare professionals (HCPs) with expertise in diabetes and nephrology formed the A New Era in Diabetes Care Steering Committee, with the mission to:

The Chair of the Steering Committee is Professor David Wheeler, Professor of Kidney Medicine at University College London and Honorary Consultant Nephrologist at the Royal Free NHS Foundation Trust, London. Other members include:

The A New Era in Diabetes Care initiative has been made possible by financial support from Mundipharma International Limited, who has provided logistical support, as well as honoraria for the Steering Committee. Mundipharma International Limited has had no input into the content of the report but have checked for factual accuracy. Final editorial control of the report remains with the Steering Committee.

About the Mundipharma network

Mundipharma is a global network of privately-owned independent associated companies whose purpose is To Move Medicine Forward. With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we have successfully transformed and diversified our European portfolio of medicines to create value for patients, healthcare professionals, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Oncology, Biosimilars, Anti-Infectives and Respiratory.

References:

1 IDF Diabetes Atlas Ninth Edition 2019. Available at: https://www.diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf Last accessed May 2020

2 Einarson T, Acs A, Ludwig C. et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007-2017. Cardiovasc Diabetol. 2018 Jun 8;17(1):83.

3 Tuttle K, Bakris G, Bilous R. et al. Diabetic kidney disease: a report from an ADA Consensus Conference. Diabetes Care. 2014; 37(10):2864-83.

4 Alicic R, Rooney M, Tuttle K. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clin J Am Soc Nephrol. 2017; 12(12):2032-45.

5 Mundipharma International Limited General Public Diabetes Awareness Survey. Carried out by Research Without Barriers from 15-27 April 2020. Data on file.

Job code: MINT/DIAB-20009

Date of preparation: June 2020

View source version on businesswire.com: https://www.businesswire.com/news/home/20200603005732/en/

Contacts

Cendrine Banerjee-Quetel Asset Communications Associate, Mundipharma International Ltd Email: Cendrine.Banerjee-Quetel.external@mundipharma.com Tel: +44 (0) 1223 393 009

Abbie Bell Account Director, Havas SO E-mail: HavasSO-Mundipharma@havasso.com Tel: +44 7375 660 515

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European Steering Committee launch A New Era in Diabetes Care report highlighting the need to improve the quality of care for people with type 2...

In early 2020, it seemed like people with diabetes were disproportionately dying with COVID-19, but the data provided more questions than answers. What type of diabetes did people have? Were people dying because the condition itself put them at greater risk, or because those with it tend to be older and have other illnesses? And what should people with diabetes do to protect themselves?

Now, researchers are harnessing data from NHS England to address these questions and some of their findings are unexpected.

It is still unclear whether people with diabetes are more likely to catch the virus. We wont know if this is true until sustained, widespread testing is rolled out. But we do know that a disproportionate number of people with the condition have been hospitalised with COVID-19. In the UK, data spanning February to April shows people with diabetes made up approximately 25% of hospitalised cases; thats almost four times higher than the estimated rate of diabetes in the general population.

Once in hospital with COVID-19, data also shows that people with diabetes have worse outcomes than people without. The increase in risk is striking but isnt necessarily surprising people with diabetes are prone to worse outcomes from infections generally, as data from flu shows.

When it comes to COVID-19, early studies suggest people with diabetes are approximately twice as likely to be categorised as having severe disease and are more likely to be admitted to intensive care units. In England, one in four people who die in hospital with COVID-19 have diabetes.

Previous studies, however, didnt shed light on the details behind these headline statistics, and didnt break down data by diabetes type. We now have this information, and it shows a significant and surprising difference.

Compared to people without diabetes, people with type 1 diabetes are approximately 3.5 times as likely to die in hospital with COVID-19, while people with type 2 are approximately twice as likely. This came as a surprise to some, because, unlike type 1, type 2 diabetes is often accompanied by other diseases, typically comes on in older age, and can be associated with raised body weight. All of these factors are linked to worse outcomes from COVID-19.

There are a number of possible explanations as to why outcomes are worse in type 1 compared to type 2.

First, the length of time someone has had diabetes might impact their vulnerability to COVID-19. Unlike type 2, people are most often diagnosed with type 1 at a young age (I was diagnosed at ten). In people hospitalised with COVID-19, someone with type 1 has likely had diabetes for much longer than someone with type 2. The longer someone has diabetes, the more likely they are to have complications, which include damage to the heart and kidneys.

Second, in type 1, your immune system attacks the cells that make insulin and you eventually stop making insulin altogether. Insulin is the hormone that helps the body process sugar in the blood. Type 2 isnt a disease of the immune system. In type 2, your body makes insulin but is resistant to it. The immune systems of people with type 1 may be different from people with type 2, which could impact how people respond to infection.

Finally, data shows that higher blood sugar levels increase the risk of COVID-19. We know that on average blood sugar levels are higher in people with type 1 than with type 2 diabetes, because of the different nature of the diseases. Blood sugar levels can be even harder to manage when fighting infections.

But these are all just theories. We need more research before we know for sure how the type of diabetes impacts COVID-19 outcomes.

To illustrate this, Im going to use myself as an example and do some crude calculations. Im 36 and have type 1 diabetes. Most people with COVID-19 arent hospitalised. However, if hospitalised with COVID-19, the average 36-year-old has a 0.3% chance of dying. Because I have type 1 diabetes, my chances of dying are 3.5 times higher. That means my current chances of dying with COVID-19 once hospitalised are around 1%.

However, if the average 80-year-old is hospitalised with COVID-19, they have a 15% chance of dying. So, though diabetes does increase my risk, my age still remains the most important factor, by far, in determining my chances of dying with COVID-19. My risk at 80 would still be higher than someone of that age without diabetes, so both would need to be taken into account.

It is really important to note that these figures are not someones overall risk of dying from COVID-19, they are the risk of dying if they contract COVID-19 and if the infection is then severe enough to warrant hospitalisation.

The advice to people with diabetes is to practice social distancing and handwashing like the rest of the population, to maintain a healthy lifestyle, and to try to keep blood sugars in an ideal range where possible.

But aiming for tighter blood sugar control can feel daunting. Now might be a particularly difficult time for people to manage diabetes, with disruptions in care, routines, activity, mental wellbeing and diet known to create challenges. Certain groups will face more challenges than others; both COVID-19 and diabetes disproportionately affect people from non-white ethnic groups and people from less advantaged backgrounds.

Support is available from healthcare providers and from organisations like Diabetes UK. Now more than ever, governments and healthcare systems need to ensure all people with diabetes get the support they need.

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Coronavirus and diabetes: the different risks for people with type 1 and type 2 - The Conversation UK

A research team led by Kobe University Graduate School of Medicine's Professor OGAWA Wataru (the Division of Diabetes and Endocrinology) and Project Associate Professor NOGAMI Munenobu (the Department of Radiology) has discovered that metformin, the most widely prescribed anti-diabetic drug, causes sugar to be excreted in the stool.

Metformin has been used for more than 60 years, and is the most frequently prescribed drug for diabetes in the world. Administration of metformin lowers blood sugar levels, but the mechanism behind this effect was not clear. Metformin's mode of action has thus been actively researched over the world.

Taking advantage of the new bio-imaging apparatus PET-MRI, the research team revealed that metformin promotes the excretion of blood sugar from the large intestine into the stool. This is a completely new discovery that has never previously been predicted.

The current finding may explain metformin's biological actions for which the underlying mechanism is unknown, and contribute to the development of new drugs for diabetes.

These findings were published on June 3, 2020 in the online edition ofDiabetes Care, a medical journal published by the American Diabetes Association.

Main Points

Research Background

Diabetes is characterized by the elevation of blood sugar concentration, which damages the blood vessels and in turn leads to various diseases. More than 400 million people suffer from diabetes around the world, therefore the prevention of diabetes and its related diseases is an important global medical issue.

A number of drugs that reduce blood sugar concentration are available. Among them, metformin is one of the oldest classes of drugs and has been used for more than 60 years. Metformin, recommended as a first-line drug in many countries, is the most frequently prescribed medication for diabetes.

However, the mechanism by which metformin lowers blood sugar concentration is not clear. Elucidation of this mechanism would contribute to the development of new and better drugs for diabetes. Consequently, research has been actively conducted into the action of metformin.

Summary of the DiscoveryFDG-PET (fluorodeoxyglucose-positron emission tomography) is an imaging test to study where and how much FDG (a substance similar to sugar) is accumulated in the body after the administration of this substance through the vessels. Because FDG behaves in a similar way to sugar in the human body, FDG-PET can reveal organs or tissues that consume or accumulate large amounts of sugar (*1).

FDG-PET is generally conduced with a device that integrates both a PET and a CT (computed tomography) device. Obtaining images using FDG-PET and CT allows for the detailed examination of locations where FDG is accumulated. Recently, a device in which PET and MRI (magnetic resonance imaging) are integrated (PET-MRI) has been developed. MRI is used to examine the inside of the body using a strong magnetic field. It can examine bodily structures that cannot be analyzed by CT. PET-MRI is still a rare and valuable device; for example, only 9 units have been installed in Japan.

Professor Ogawa's research team used PET-MRI to investigate the movement of sugar in the bodies of diabetic patients, both those who were taking metformin and those who were not. The team found that sugar (i.e. FDG) is heavily accumulated in the intestine of patients taking metformin (Fig. 1). To understand where in the intestine sugar accumulates, the research team subsequently investigated the "wall of the intestine" and the "inside of the intestine (stool and other contents)" separately using a special technique.

They found that, in patients taking metformin, more sugar was accumulated in the areas inside the intestine that are distal to the ileum (the anal side part of the small intestine) (Fig. 2). On the other hand, there was no difference in sugar accumulation in the "wall of the intestine" between patients who were taking and not taking metformin.

These results indicate that, when a patient takes metformin, sugar in the blood is released from the intestine into the stool. Not only the finding that metformin promotes the excretion of sugar into the stool, but also the revelation that sugar is excreted from the intestine into the stool itself are new discoveries that were not anticipated.

Recently, a new anti-diabetic drug has been launched; the SGLT2 inhibitor, which lowers blood sugar concentrations by excreting sugar in the urine. Its beneficial clinical effects are attracting much attention. Excreting sugar into the stool, as triggered by metformin, may also be related to the SGLT2 inhibitor's sugar lowering effect.

The significance of this research and its future development

Previous studies using PET-CT showed that FDG was accumulated in the intestines of patients taking metformin. It was however assumed that FDG (sugar) was accumulated in the "wall of the intestine" without sufficient evidence because PET-CT cannot separately show the wall and the inside the intestine. In the current study, the new imaging technology PET-MRI allowed the research team to investigate the accumulation in the wall and the inside of the intestine (stool) separately, revealing for the first time that metformin-induced accumulation of sugar occurred exclusively inside the intestine.

Taking a SGLT2 inhibitor results in the excretion of tens of grams of sugar per day in the urine. In this study, it was not possible to quantitatively evaluate how many grams of sugar are excreted in the stool. The significance of this discovery will be further confirmed by using a new imaging method that will enable the excreted sugar in the stool to be quantified.

It is thought that changes in the intestinal flora caused by metformin (*2) are related to its blood sugar lowering effect, but how metformin alters the intestinal flora is completely unknown. Since changes in nutrients such as sugar affect the growth of bacteria, it is possible that metformin's effect of excreting sugar into the intestine may also be related to the changes in the intestinal flora.

Glossary

*1 Since cancers consume more sugar than normal tissue, FDG-PET is generally used to find cancers that are difficult to detect using other tests.

*2 The human intestine is inhabited by 100 to 1000 trillion intestinal bacteria, and these bacteria as a whole are referred to as intestinal flora. It is known that changes in the intestinal flora are related to the pathogenesis of diseases and the effects of drugs.

Reference:Morita, et al. (2020) Enhanced Release of Glucose into the Intraluminal Space of the Intestine Associated with Metformin Treatment as Revealed by [18F]Fluorodeoxyglucose PET-MRI. Diabetes Care. DOI: 10.2337/dc20-0093

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New Insight Into Metformin's Mode of Action As Anti-diabetic Drug - Technology Networks

Fractyl Laboratories is seeking to turn back the clock in Type 2 diabetes progression with its disease-modifying therapy.

FDA granted the Lexington, MA-based company IDE to launch a pivotal trial of the Revita DMR, a which holds the potential to eliminate the need for insulin injections in patients suffering from Type 2 diabetes.

Insulin is a challenging drug for patients with Type 2 diabetes because it can cause weight gain, Harith Rajagopalan M.D. Ph.D., co-founder and CEO of Fractyl told MD+DI. It can cause a risk of your blood sugar to drop too low (hypoglycemia); it can carry a stigma of injecting yourself with insulin, and can add a lot of burden to daily disease management.

He added, Revitas initial pivotal trial indication is to test the ability of the device to get patients off of insulin and back on to oral medications.

The pivotal trial is called Revita T2Di and is a prospective, randomized, double-blind, sham-controlled study enrolling 300 patients at up to 35 sites around the world, with approximately 25 sites in the U.S.

Patients who have inadequately controlled T2D despite taking both oral drugs and insulin injections as well as adopting lifestyle changes will be enrolled in the trial. The primary endpoint of the study will be the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.

Fractyl won CE mark for Revita in 2016.

Earlier this year, we signed a historic contract with the HCA Hospital in the UK to offer Revita Commercially to patients, Rajagopalan said. Just as we were going to launch that service offering in partnership with HCA COVID-19 swept through the world and Europe. Elective procedures were halted. So, we have paused our commercial activities while we wait for the situation to clear.

Because of the impact COVID-19, the company isnt giving guidance on a timetable for its pivotal trial other than to say it could start at the end of this year.

Rajagopalan said, I think its a bit early to prognosticate on how our phased-reopening in the U.S. is going to affect what our situation is going to look like in 3Q20 and 4Q20; what impact a second wave might have; what impact this disease has on hospitals backlog; and the need to catch up on really important procedures that affect health.

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Fractyl Seeks to Turn Diabetes On Its Ear with Revita DMR - Medical Device and Diagnostics Industry

Loss of a pregnancy may increase a womans risk of developing Type 2 diabetes, Danish researchers report.

Their study, in Diabetologia, included 24,774 women who developed diabetes after pregnancy and 247,740 controls who did not.

Compared with women who had been pregnant without losing a baby, those who lost one were at an 18 percent increased risk for diabetes, those who lost two were at a 38 percent higher risk and those who lost three or more had a 71 percent higher risk. The study adjusted for obesity and gestational diabetes, which are known to be associated with the development of Type 2 diabetes.

The reason for the association remains unknown. It may be that the same genetic background increases the risk for both pregnancy loss and diabetes, or that pre-diabetes present before the diagnosis of diabetes could lead to both. In any case, the authors stress that the observational finding does not prove cause and effect.

The lead author, Dr. Pia Egerup, a researcher at the Recurrent Pregnancy Loss Unit of the Rigshospitalet and Hvidovre Hospital in Copenhagen, said that the most important clinical implication is that pregnancy loss is a risk factor for diabetes.

Pregnancy loss is not only due to fetal disease, she said. A large proportion are healthy fetuses lost because of maternal conditions. As clinicians, we want to optimize pregnancy success and minimize the risk for future diabetes.

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Pregnancy Loss Tied to Increased Risk of Type 2 Diabetes - The New York Times

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.

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