Open-Source Automated Insulin Delivery in Type 1 Diabetes

Area of Science:

• Endocrinology
• Biomedical Engineering
• Diabetes Technology

Background:

• Open-source automated insulin delivery (AID) systems are increasingly adopted by individuals with type 1 diabetes.
• There is a need for robust data on the efficacy and safety of these open-source AID systems.

Purpose of the Study:

• To evaluate the efficacy and safety of an open-source AID system compared to a sensor-augmented insulin pump in patients with type 1 diabetes.
• To determine the impact of the open-source AID system on time spent within the target glucose range.

Main Methods:

• A multicenter, open-label, randomized controlled trial involving 97 patients (children and adults) with type 1 diabetes.
• Participants were randomized 1:1 to use either an open-source AID system (AndroidAPS 2.8/OpenAPS 0.7.0 algorithm, DANA-i pump, Dexcom G6 CGM) or a sensor-augmented insulin pump.
• The primary outcome was the percentage of time in the 70 to 180 mg/dL glucose range between days 155 and 168.

Main Results:

• The open-source AID group showed a significant increase in time within the target glucose range, from 61.2% to 71.2% over 24 weeks.
• The control group experienced a decrease in time within range, from 57.7% to 54.5%.
• Patients using the AID system spent an additional 3 hours and 21 minutes per day in the target glucose range, with no severe hypoglycemia or diabetic ketoacidosis reported.

Conclusions:

• The open-source AID system significantly improved glycemic control, as measured by time in target glucose range, in both children and adults with type 1 diabetes.
• The findings support the use of open-source AID systems as an effective management strategy for type 1 diabetes.
• No severe adverse events were observed in the AID group, though connectivity issues led to two withdrawals.