NEW ORLEANS – Open-source automated insulin delivery systems appear to be both effective and safe in adults and children, new research finds.
Automated insulin delivery (AID) system, also known as closed-loop systems or an artificial pancreas, link an insulin pump and a continuous glucose monitor (CGM) with an algorithm that automatically adjusts insulin delivery to optimize glycemic control.
Prior to the availability of commercial AID systems, Dana Lewis, a patient with type 1 diabetes, and her partner codeveloped an algorithm that could link older versions of an insulin pump and CGM.
In 2015, they made the code and all related materials open-source, so that anyone who wanted to create their own AID system could do so. Today thousands of people worldwide with type 1 diabetes are using the systems, which are sometimes called “do-it-yourself (DIY)” AID systems although the approach has been community based.
AID systems are not approved by any regulatory body, and despite several nonrandomized studies demonstrating their effectiveness and safety, there is still concern among some health professionals about their safety. In 2019, the U.S. Food and Drug Administration warned against the use of any nonapproved devices or algorithms. (Now, though, at least one open-source AID system algorithm is under FDA review.)
Aimed at addressing those concerns, CREATE (Community Derived Automated Insulin Delivery) is the first randomized controlled clinical trial to compare an open-source AID system to insulin pump therapy and CGM (without any communication between the two) in patients with type 1 diabetes, most of whom were naive to AID systems.
Doctors uncomfortable with open source; study provides reassurance
The findings were presented at the American Diabetes Association scientific sessions by Martin I. de Bock, PhD, a pediatric endocrinologist and senior lecturer at the University of Otago, Christchurch, New Zealand.
The study compared the most commonly used open-source AID system (using the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone with the DANA-i insulin pump and Dexcom G6 CGM) to any insulin pump plus CGM as a comparator group.
The open-source AID system led to a significant reduction in hemoglobin A1c with no major safety issues.
“The acceptance [among clinicians] of open-source systems is diverse and complicated, [with varying] personal comfort levels of seeing someone using an AID system that has no regulatory approval,” Dr. de Bock told this news organization.
“This is one of the reasons that it was so important to conduct the CREATE trial for the many thousands of open-source AID users. Given that the trial demonstrated safety and efficacy using the most robust scientific methodology available – a long-term randomized controlled trial – it may go some way to provide assurance for providers when they are seeing people using an open-source automated system,” he said.
Asked for comment, session moderator Diana Isaacs, PharmD, CDCES, an endocrine clinical pharmacist at the Cleveland Clinic, told this news organization: “There has been concern that these systems aren’t safe, so showing the safety is important. I think people deserve choice. As long as they’re safe, patients should be able to use what they want to use, and we should support them.”
Dr. Isaacs pointed out that an advantage of open-source systems over current commercial AIDs for patients is the ability to customize glucose targets, but in CREATE, those targets were established in the protocol by the investigators.
“I think it’s nice having the data, although in the trial they had specific requirements. They had a target range and active insulin time that they were recommending. So it’s a little different than true DIY where you don’t really have those guidelines you have to follow. It is exciting, it’s very interesting, but I wouldn’t say it’s a true mirror of the real world.”