Speed Poster ESA-SRB-APEG-NZSE 2022

Efficacy and safety of an open-source automated insulin delivery system over 48 weeks of use in the CREATE randomised controlled trial (#74)

Mercedes Burnside 1 , Dana M Lewis 2 , Hamish Crocket 3 , Renee Meier 1 , Olivia Sanders 1 , Jonathan Williman 4 , 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 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: To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults with type 1 diabetes (T1D) in a 24-week continuation phase following a 24-week multi-site randomised controlled trial.

Methods: Two arms from a 24-week randomised (1:1) controlled trial (RCT) that compared open-source AID (OpenAPS algorithm within a modified version of AndroidAPS in a smartphone, pre-production DANA-i insulin pump, Dexcom G6 continuous glucose monitor), to sensor augmented pump therapy (SAPT), entered into a 24-week continuation phase where the SAPT arm (SAPT-AID) crossed over to join the open-source AID arm (AID-AID). A hardware switch occurred in the majority of participants in the continuation phase, where the pre-production DANA-i insulin pump was substituted with a pre-production YpsoPump.

Results: In the SAPT-AID group (n=52), mean percentage of time in range (TIR; 3.9-10mmol/L) increased from 54.5±16% using SAPT during the RCT to 67.4±10.6% using AID (Δ+12.9%, 95% confidence interval (CI) 9.6 to 16.2; p<0.001), with 44% achieving TIR >70% compared to 15% using SAPT (p<0.001). In the AID-AID group (n=42), mean TIR increased from 61.2±12.3% pre-randomisation to 71.2±12.1% during the RCT and remained stable at 69.3±12.5% during the final two weeks of the continuation phase (Δ-1.9% from the RCT, 95% CI -5.6 to 1.8; p=0.310). By the end of the continuation phase mean TIR was almost identical between treatment groups (p=0.92). No episodes of diabetic ketoacidosis or severe hypoglycaemia occurred in either group. Four participants in the SAPT-AID group withdrew; 1 due to infusion site skin irritation, 1 due to a hardware issue, 2 preferred SAPT.

Conclusion: Further evaluation of the CREATE trial to 48 weeks (24 weeks post RCT) confirms open-source AID using the OpenAPS algorithm within a modified version of AndroidAPS is efficacious and safe with various hardware, and demonstrates sustained glycaemic improvements without additional safety concerns.