DIY Automated Insulin Dosing Stakeholders Issue Statement to FDA Warning Against Such Systems

DIY Automated Insulin Dosing Stakeholders Issue Statement to FDA Warning Against Such Systems

Update: 5/18/2019 – Tidepool community manager Christopher Snider provided comment to this statement: “We support the statement shared by the DIY community, to which we contributed the info we had from the FDA.”

-Craig Idlebrook

Today, the FDA issued a warning against the use of DIY automated insulin dosing systems; the agency released the warning after it has received report of a hospitalization from someone using a DIY automated dosing system.

In response, stakeholders from various branches of the DIY automated insulin dosing movement have released a joint statement on the Looped Facebook group and on Twitter.

Here is the statement in its entirety:

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

As had been posted previously in Looped group discussions about Spike/X-drip and off-label CGM algorithms, there had been a report of hospitalization due to hypoglycemia of a user in MiaoMiao + Libre on a DIY system outside of the USA. We had no further information at the time and further information has not been provided to DIY developers at this time despite efforts to learn more.

Howard Look (Tidepool CEO) has been in contact with the FDA about this announcement. Questions naturally arise as to whether this is the same event, what exactly happened, was this reported? The response has been that this announcement is the result of a report of a single patient outside of the USA using Miao Miao + Libre on OpenAPS algorithm (unspecified system type) and two hypoglycemia events occurred; first event patient self-treated and the second required medical assistance. The patient has since recovered.

As has been stated before, FDA is aware of the DIY community. This announcement brings up something very important we need to address; an opportunity for the DIY community to double down on its commitment to radical transparency and responsibility.More updates to come, but yes…the DIY community of developers across all systems are aware and engaged in this report and announcement. To make this super emphasized:

**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.**

Reports can be submitted to the channels already in place for discussing issues with DIY systems. If you want to maintain privacy, that’s fine too; the maintainers of these systems do want to know if there are problems, and are reachable through private messages on those channels as well. We are looking into systems that can help make submission of adverse events easy for users, transparent, but still respecting of privacy. Nothing like this exists today, but is needed.

If you have any questions, please add them to the comments below.

This post has been collaboratively written and co-signed by the core developers of Loop, OpenAPS, and AndroidAPS. Tagging them here so that Facebook does a better job of notifications for this post; Dana, Scott, Milos, Adrian, Pete.”

This is a developing story and will be updated as new information comes to light.

You can read about the FDA warning here.

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