As open-source artificial pancreas systems gain traction, we feature the first multi-centre trial published in New England Journal of Medicine
In diabetes care, open source refers to freely available software code that people in the type 1 diabetes community are using to build their own artificial pancreas systems (OpenAPS). The code allows insulin pumps to alter insulin delivery based on information from a continuous glucose monitor worn by the person.
Open source is also known as do-it-yourself or DIY. The DIY systems have gained traction in response to the slow pace of development and regulation of commercial systems. Our group has written about how people are navigating these challenges here.
More than 2,700 people use DIY systems across the world. While this remarkable user-led movement is driving innovation, concerns about safety and effectiveness have been raised. This is because there have been no randomised controlled trials (RCTs) of this technology. RCTs are the ‘gold standard’ for testing the effect of an intervention.
The CREATE study is the first RCT to compare OpenAPS with a commercial system. CREATE recruited 97 people with type 1 diabetes, aged seven to 70 years. The main outcome was time in target glucose range (TIR). The more time spent with glucose in target range, the less time is spent with glucose levels ‘at risk’ with high or low glucose.
At the end of the 24-week trial, people allocated to the OpenAPS group spent 3 hours and 21 minutes more per day, than those in the commercial group, with glucose in target range. There were no safety concerns for either group.
CREATE provides important new evidence. It shows that OpenAPS is a safe and effective option for both children and adults with type 1 diabetes.
Reference: Burnside MJ, Lewis DM, Crocket HR, Meier RA, Williman JA, Sanders OJ, Jefferies CA, Faherty AM, Paul RG, Lever CS, Price SKJ, Frewen CM, Jones SD, Gunn TC, Lampey C, Wheeler BJ, de Bock MI. Open-Source Automated Insulin Delivery in Type 1 Diabetes. N Engl J Med. 2022; 387(10):869-881.Print This Post