Oral Presentation ESA-SRB-APEG-NZSE 2022

Six-month randomised trial of open-source automated insulin delivery in Type 1 Diabetes (#65)

Mercedes J Burnside 1 , Dana M Lewis 2 , Hamish Crocket 3 , Renee Meier 1 , Jonathan Williman 4 , Olivia sanders 1 , Craig Jefferies 5 , Ann Faherty 5 , Ryan Paul 6 , Claire Lever 6 , Sarah Price 6 , Carla Frewen 7 , Shirley Jones 7 , Tim Gunn 8 , Christina Lampey 5 , Ben J Wheeler 7 , Martin de bock 1
  1. University of Otago, Christchurch, Christchurch, CANTERBURY, New Zealand
  2. OpenAPS, Seattle, WA, United States of America
  3. Te Huataki Waiora School of Health, Sport & Human Performance, University of Waikato, Hamilton, New Zealand
  4. Biostatistics and Computation Biology Unit, University of Otago, Christchurch., University of Otago, Christchurch, Christchurch, Please Select, New Zealand
  5. Department of Pediatric Endocrinology, Starship Children’s Health, Auckland District Health Board, Auckland, New Zealand
  6. Waikato Regional Diabetes Service, Waikato District Health Board, Hamilton, New Zealand
  7. Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
  8. Nightscout, Hamilton, New Zealand

Aims: Open-source automated insulin delivery (AID) predated the availability of commercial systems and is used by thousands with type 1 diabetes (T1D) despite no regulatory approval. We examined efficacy and safety of an open-source AID system.

Methods: A 24-week, multi-center randomised (1:1) controlled trial in children (7–15 years) and adults (16–70 years) with T1D, comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS in a smartphone, pre-production DANA-i™ insulin pump, and Dexcom G6® CGM), to sensor augmented pump therapy (SAPT). The primary outcome was percent time in target sensor glucose range (TIR; 3.9–10.0 mmol/L), between AID and SAPT during days 155-168 (final 2 weeks of the study).

Results: Ninety-seven participants (48 children, 49 adults) were randomised (44 to open-source AID and 53 SAPT). The mean adjusted difference in TIR between AID and SAPT at end of study was 14% (95% confidence interval (CI), 9.2 to 18.8; P<0.001), with no treatment effect by age interaction (p=0.56). AID users spent 3 hours 21 minutes (95% CI, 2h 12m to 4h 30m) more in target range per day. In the AID arm, mean TIR (±SD) increased from 61.2±12.3% to 71.2±12.1%, and decreased from 57.7±14.3% to 54±16% in the SAPT arm. More participants achieved TIR >70% using AID (60% vs. 15%). No severe hypoglycemia or diabetic ketoacidosis occurred in either arm. Two participants withdrew from AID due to connectivity issues.

Conclusion: Open-source AID using the OpenAPS algorithm within a modified version of AndroidAPS, a widely used open-source AID solution, is efficacious and safe.