When diabetes advocates first began reporting good results from their own closed-loop insulin delivery systems, optimism was tempered by the lack of clinical validation of the homemade systems. Now, a DIY algorithm is being utilized in a clinical trial that could eventually lead to FDA approval.
On January 17th, researchers with the Jaeb Center for Health Research and Stanford University began recruiting between 300 and 1000 children and adults with type 1 diabetes who use or plan to use Loop, the DIY automated insulin delivery algorithm. Tidepool, a company which has championed Loop, hopes to submit Loop for FDA approval, according to Tidepool CEO Howard Look in a blogpost.
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Loop is already in use in real-world settings, and this will be an observational study. Participants will be asked to report any serious device issues and adverse blood sugar management events, like diabetic ketoacidosis and hypoglycemia. Researchers will gather this data, as well as blood samples for HbA1c measurement.
If Tidepool can bring its version of the Loop algorithm to the FDA, it may be the first to be granted iController approval. The FDA has created a new designation for diabetes tech and algorithms that may be used interoperably with diabetes tech from other companies. The FDA has already approved the Tandem t:slim X2 as an iPump and Dexcom G6 as an iCGM. iController status will be granted to interoperable algorithms that could be used in closed-loop pump systems.
The trial, and the work to bring the Tidepool Loop before the FDA, is being funded by a $6 million grant from The Leona M. and Harry B. Helmsley Charitable Trust and JDRF as part of JDRF’s Open Protocol Initiative. The initiative, launched in 2017, aims to provide better choice and control for those who use diabetes technology.
To learn more about the trial, click here.
4/10/2019 – An earlier version of this story stated that Tidepool was actively recruiting for this study. Tidepool is not actively involved in the recruitment, although it supports this endeavor.