• Commercial airline pilots flying with insulin-controlled diabetes had no incidents of medical incapacitation in more than 18 months of study, researchers reported by the European Association for the Study of Diabetes, 12 September 2016 via MedPageToday.com.

uk-caaThe study was conducted by the medical staff at Royal Surrey County Hospital and the U.K. Civil Aviation Authority (CAA), based at London’s Gatwick Airport.

The researchers found that at the analysis date, 26 insulin-treated pilots had been issued with Class 1 medical certificates. All were men, with an average age of 41. The majority (85%) had type 1 diabetes, with an average diabetes duration of 8 years.

Of the 26 insulin-treated pilots flying planes under the U.K. flag, a total of 8,897 blood glucose monitoring values had been recorded during 4,900 flight hours with more than 96% of the cockpit glucose monitoring readings indicating pilots with diabetes were in the “Green Zone” for safety, reported Julia Hine, MD, of the Royal Surrey County Hospital in Guildford, England. That aviation agency defines the “green zone” as glucose levels between 90 to 270 mg/dL

U.S. pilots with a diagnosis of diabetes are not permitted to pilot commercial airlines.

Read more: U.K. Airline Pilots Fit to Fly With Diabetes

 

  • Do You Need More T Cells to Stop Type 1 Diabetes? The FDA fast-tracks a treatment that would, in theory, use T cells to stop Type 1 diabetes in its tracks, as reported by Kathleen Doughty of Insulin Nation, 9 September 2016.

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A novel treatmen t meant to stop Type 1 diabetes by increasing the number of T cells in the body is being given special attention by the FDA. The treatment, called CLBS03, has recently been granted Fast Track status by federal regulators, a designation which speeds up the approval process.

The CLBS03 treatment clones T cells from the patient to combat Type 1 diabetes. This may at first seem counterintuitive, as T cell attack is what destroys insulin-producing beta cells in the first place. However, the T cells in this treatment (T regs) regulate T effector cells, which are the cells that attack the body in autoimmune diseases. Essentially, the T regs would manage malfunctioning T effectors and, in theory, stop beta cell destruction. T regs have been used to effectively treat other autoimmune conditions.

The treatment is being developed by Sanford Health, in collaboration with Caladrius Biosciences, Inc.

Previously, Phase I studies with the drug showed that treatment preserved pancreatic beta cell function and reduced insulin requirements. Currently, this drug is being tested in a Phase II trial that involves 111 teens with Type 1 who still have residual beta cell function. To learn more about enrollment for this trial, go to http://www.sanfordhealth.org/promo/the-sanford-project.

 

  • Glooko and Diasend Merge to Deliver the World’s Premier Diabetes Management Platform, as reported in VentureBeat.com, 13 September 2016.

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For people either living with or caring for people with diabetes, Glooko and Diasend are well-known for making diabetes management easier by offering best-in-class diabetes management and analytics platforms that facilitate data driven care for patients and clinicians. In a move that will accelerate the overarching mission to make diabetes management easier worldwide, Glooko and Diasend today announced they have merged into a unified company.

“This is a big day for us – we are thrilled to come together to be able to deliver products and services that will offer even more value to patients and healthcare providers around the world,” says Rick Altinger, CEO of Glooko, Inc.

“This is without a doubt the best possible scenario for our two companies, as well as for patients and the care teams that serve them. From our standpoint, this means adding even more functionality to an already very strong technical platform,” says Anders Sonesson, CEO of Diasend AB.

As a combined entity, the new company now serves 4,000 diabetes clinics in 23 countries across 15 languages, impacting tens of millions of people with diabetes. The joint platform downloads data from more than 160 different devices – including glucose meters, insulin pumps, continuous glucose monitors (CGMs) and activity trackers, in total covering over 95% of diabetes devices used worldwide.

The two companies, which have chosen to unite under the Glooko name

Read more:  Glooko and Diasend Merge       

 

  • The Hype and The Hope: The Journey from Consumer to Medical-Grade Wearables is the first white paper in a 2-part series about the current environment for health wearables and some of the challenges involved, as reported in Pharmaphorum.com, September 2016.

pharmaphorum-logoThe survey was also completed by related businesses such as IT-solutions providers and medical-communications agencies, and other stakeholders in health wearables including healthcare providers and researchers. The results were supplemented with in-depth interviews involving a pharmaceutical and healthcare consultant, a general practitioner active in digital health, and a diabetes patient with extensive personal experience of mobile-health technology

It concludes: If health wearables are to realize the considerable potential they hold to facilitate cost-effective treatment and prevention of high-burden diseases, as well as helping to steer R&D processes and therapeutic interventions towards truly personalized medicine, they will have to negotiate a range of barriers, be they legal, regulatory, technical, practical, or cultural.

This speaks to the need for a broadly collaborative approach to integrating wearables into the mainstream of healthcare provision, one that involves trust, understanding, and innovative thinking on all sides.

Stay tuned for Part Two, which will examine more closely industry’s current and potential role in health wearables, including the associated regulatory and legal challenges, the applications of real-world data from wearables, and how life sciences companies can add value to the technology. Industry experts will provide recommendations on taking the sector forward.

Read more: The Hype and The Hope

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