New Zealand Study on Automated Insulin Delivery Systems

The use of open-source automated insulin delivery (AID) systems versus a sensor-augmented insulin pump in adults and children with type 1 diabetes led to a notably higher percentage of time in the target blood sugar, a recent study has stated. The findings were published in the New England Journal of Medicine.

Automated insulin delivery (AID) systems are automated (or semi-automated) systems designed to assist people with diabetes, primarily those with type 1 diabetes. The system automatically adjusts insulin delivery to control blood sugar levels. The systems are also referred to as artificial pancreas, but the term has no universally accepted or precise definition.

Considering the increased use of open-source AID systems by type 1 diabetes patients, Martin I. de Bock, Department of Pediatrics, University of Otago, Christchurch, New Zealand, and colleagues aimed to determine the safety and efficacy of an open-source automated insulin delivery (AID) system.

For this purpose, type 1 diabetes patients (n=97) were assigned to a multicenter, open-label, randomized, controlled trial in a 1:1 ratio to use an open-source AID system (n=44) or a sensor-augmented insulin pump (control; n=53).

Children (aged 7 to 15 years) and adults (aged 16 to 70) were included in the study. The AID system was a modified form of AndroidAPS 2.8 coupled with a preproduction DANA-i insulin pump and Dexcom G6 CGM which has a user interface of an Android smartphone application. Between days 155 and 168, the percentage of time in the target glucose range of 70 to 180 mg per deciliter (the final two trial weeks).

Study Findings

• In the AID group, there was an increase in the meantime in the target range from 61.2±12.3% to 71.2±12.1% and a decrease from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points), with no treatment effect according to age.
• Three hours and 21 minutes more were spent by patients in the AID group in the target range per day compared to patients in the control group.
• In either group, no severe hypoglycemia or diabetic ketoacidosis was observed.
• Owing to connectivity issues, two patients in the AID group withdrew from the trial.

"Open-source AID system use in children and adults with type 1 diabetes led to a significantly higher percentage of time in the target glucose range over the use of a sensor-augmented insulin pump at 24 weeks," the researchers concluded.

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 Sep 8;387(10):869-881. doi: 10.1056/NEJMoa2203913. PMID: 36069869.