There have been numerous studies on OpenAPS and open source automated insulin delivery systems over the past several years.

Some are retrospective studies based on real-world data; some are prospective or observational studies; and now, as of today, there is a published RCT (randomized control trial)  assessing safety and efficacy of the OpenAPS algorithm. This article was published in the New England Journal of Medicine (NEJM) in the September 8, 2022 issue.

You can find the article on NEJM here.

Key results:

• The mean time in range was significantly greater with the open source AID system used in the study (a modified version of the AndroidAPS app which uses the OpenAPS algorithm) — participants spent 3 hours 21 minutes more time in range each day than those with sensor-augmented insulin pump therapy (SAPT, meaning a pump and a CGM but no automated insulin delivery). Benefits with AID were seen among both children and adults. No episodes of severe hypoglycemia or DKA occurred in either group.
• The conclusion from the study is that among children and adults with type 1 diabetes, use of an open-source automated insulin delivery system (using the OpenAPS algorithm in a modified version of AndroidAPS) resulted in a significantly higher percentage of time in the target glucose range than use of a sensor-augmented insulin pump, without an increase in adverse events.

Dana Lewis has also written a plain language summary of the key takeaways from the study and provided some commentary on the impact of having an open source, patient-developed/community-developed system studied in an RCT and published in NEJM.