Open-Source Automated Insulin Delivery Safe and Effective Option among Type 1 Diabetes patients

Results from the CREATE Trial demonstrated open-source automated insulin delivery (AID) systems are a safe and effective therapy for people with type 1 diabetes. Findings from the randomized controlled trial (RCT) comparing open-source AID to sensoraugmented pump therapy (SAPT) were presented today at the 82 nd Scientific Sessions of the American Diabetes Association® (ADA).

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 five minutes to keep glucose levels in target range. 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.

The CREATE Trial is the first randomized controlled trial to evaluate the safety and efficacy of the most commonly used open-source AID system. The study compared open-source AID, using the Open APS algorithm from a version of AndroidAPS implemented in a smartphone with the DANA-i™ insulin pump and Dexcom G6® CGM, to SAPT. A diverse population of patients, many of whom had little or no experience with AID, were recruited to a 24-week, multi-center RCT, which included children (7–15 years) and adults (16–70 years), to examine efficacy and safety of open-source AID.

Results of the trial included:

1. The primary outcome was the percent of time in target sensor glucose range (TIR; 3.9-10 mmol/L [70-180 mg/dL]) between open-source AID and SAPT during the last two weeks of the RCT.

2. Both children and adults achieved more time in range (TIR), when using the open-source AID system compared to treatment without automation (SAPT). 

3. 97 patients (48 children and 49 adults) were randomized.

4. The overall treatment effect resulted in a 14% difference in TIR, favoring the opensource AID treatment group.

5. Mean TIR (±SD) at study end was 74.5±11.9% using AID (Δ+ 9.6±11.8% from run-in; P<0.001) for adults and 67.5±11.5% (Δ+ 9.9±14.9% from run-in; P<0.001) for children. TIR did not improve in the SAPT group.

6. 60% of participants using open-source AID met the TIR target set by international guidelines of >70%, compared to just 15% in the SAPT arm.

7. Only two participants withdrew from AID due to hardware issues.

8. No severe hypoglycemic or diabetic ketoacidosis events occurred in either treatment group. There was no increase in overall hypoglycemia.

9. The improvement in time in range in both children and adults using open-source AID was immediate and sustained for the study duration. 

"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.

"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," commented Dr. Martin de Bock, pediatric endocrinologist at the University of Otago, Christchurch, New Zealand, and lead investigator of the study.

The authors hope these findings provide both people with diabetes and clinicians with additional information to use when evaluating open-source AID options for people living with diabetes.