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The FDA (US) issued a stern warning last week about do-it-yourself (DIY) artificial pancreas (AP) systems after a person with diabetes suffered an accidental insulin overdose while using a DIY AP.  Although it isn’t clear how the malfunction occurred, the person who suffered the overdose, required immediate medical attention.  The person has since recovered.

This is the first warning the FDA has issued about DIY systems.

The FDA statement reads, “These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use,” the agency wrote. “Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.”

What is a DIY AP or closed loop system?

DIY systems combine FDA-approved components, including insulin pumps and continuous glucose monitors (CGM), with open source software to deliver continuous doses of insulin. The Open Artificial Pancreas (OpenAPS) movement, led by Dana Lewis, was launched in 2015, and today thousands of people worldwide are using the systems.

The DIY movement, whose objective is to achieve optimal blood glucose results with the DIY technology, build their own glucose management devices, or combine assorted manufacturers’ devices into homemade artificial pancreas. One of the benefits of the DIY AP is a good night’s sleep, which for many with type 1 diabetes is out-of-reach.  The movement’s efforts have  been lauded by health researchers for their achievements, however, the FDA ‘s warning is speaking to both consumers and healthcare professionals about the serious risks that may develop from these untested technologies.

Many people with type 1 diabetes are dissatisfied with current commercial options for FDA approved integrated pumping systems, and for others, diabetes technologies are unaffordable or not covered by insurance.

Why are people turning to DIY artificial pancreas systems?

Many people with type 1 diabetes are dissatisfied with current commercial options for FDA approved integrated pumping systems, and for others, diabetes technologies are unaffordable or not covered by insurance. The Nightscout #Wearenotwaiting  tagline was used by proponents of the DIY movement whose goal is to make diabetes data more accessible, intuitive, and actionable. The objective is to get usable data into a format where it increases “time in (glucose) range”, and helps achieve fewer lows and better HbA1cs. Dexcom, whose CGM technology was a catalyst for the DIY innovation became the first-ever major FDA-approved medical device provider to launch a public application programming interface (API) as opposed to the proprietary, closed data platforms used by most devoice companies.

Members of the Nightscout #WeAreNotWaiting movement summarized their intentions over the years with the following:

#WeAreNotWaiting for competitors to cooperate.

#WeAreNotWaiting for regulators to regulate.

#WeAreNotWaiting for device manufacturers to innovate.

#WeAreNotWaiting for peace of mind that our children with type 1 diabetes are safe.

#WeAreNotWaiting to get some decent sleep for the first time in years.

#WeAreNotWaiting for the cure.

In response to the FDA statement, stakeholders from various branches of the DIY automated insulin dosing movement released a joint statement on the Looped Facebook group and on Twitterwhich stated in part,

“Today the FDA released an announcement regarding a warning about DIY systems within the diabetes community.

We want you to report adverse events on DIY systems, if and when they occur. We do not support any kind of efforts to minimize or avoid discussing/reporting adverse events. Openly sharing – including any potential issues – is an equally important part of the “open” aspects of the DIY community.”

One member of IDF Blue Circle Voices, Renza Scibilia, summed it up on Twitter best, “ALL diabetes is DIY. It is 24/7 and we do it ourselves for day to day. Call it what you want – DIY or off-label diabetes – it’s just diabetes. And we have no choice other than doing it ourselves.”

 

Elizabeth Snouffer is Editor of Diabetes Voice


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1 Comment
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  • Hilary Whitlock

    November 23, 2019 at 3:58 am

    Yes. I have something to say. How dare the FDA !
    What about the for profit companies that are rushing to market flawed devices approved by the FDA that claim to be safe. While their customers receive emails with warnings about “rapid infusion of insulin” due to a product malfunction. They settle out of court over and over again. Passing it off as human error or natural causes over taking responsibility for these imperfect medical devices that are capable of killing an unsuspecting insulin pump user.