New research supports the safety of automated insulin delivery systems.
Open-source automated insulin delivery (AID) systems are a safe and effective therapy for people with type 1 diabetes, according to research presented at 82nd Scientific Sessions of the American Diabetes Association® (ADA) in New Orleans, LA, June 3-7, 2022.1
Dr. Martin de Bock, pediatric endocrinologist at the University of Otago, Christchurch, New Zealand, and lead investigator of the study, presented findings from the CREATE Trial, the first randomized controlled trial to evaluate the safety and efficacy of the most commonly used open-source AID system, the ADA said in a news release.2
Open-source AID systems were developed to reduce the burden of living with diabetes by combining an insulin pump, continuous glucose monitor (CGM), and an algorithm that automatically adjusts insulin delivery every 5 minutes to keep glucose levels in target range, ADA said.
“The technology was developed by people with diabetes and shared openly, commonly referred to as open-source, so that others could evaluate the system and choose to use it themselves. These open-source systems were available for years before commercial AID systems and are used by people with type 1 diabetes worldwide,” ADA added.
“While open source AID is not yet approved by the FDA, we know people worldwide are using it to manage their diabetes. Our findings demonstrate that this is a safe and effective technology and adds to the body of evidence supporting use of open-source AID for improving glycemic outcomes,” de Bock said.
The researchers compared open-source AID, using the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone with the DANA-i™ insulin pump and Dexcom G6® CGM, to sensor-augmented pump therapy (SAPT).
The researchers recruited a diverse population of patients, many of whom had little or no experience with AID, to a 24-week, multi-center randomized control trial. The trial included children ages 7 to 15 years and adults ages 16 to 70 years.
They found that both children and adults achieved more time in range (TIR), when using the open-source AID system compared to treatment without automation (SAPT). The overall treatment effect resulted in a 14% difference in TIR, favoring the open-source AID treatment group.
No severe hypoglycemic or diabetic ketoacidosis events occurred in either treatment group, and there was no increase in overall hypoglycemia.
“We were encouraged to see the greatest improvements in time in range were in those who had the lowest time in range at the start of the study. This supports the finding that a wide range of people with diabetes who want to use this technology could benefit from it, regardless of their outcomes with previous therapies,” said Dana Lewis, diabetes researcher, a founder of the open-source artificial pancreas movement, OpenAPS, and study investigator.