Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial.

Autor: Burnside MJ; Department of Pediatrics, University of Otago, Christchurch, Christchurch, New Zealand.; Pediatric Department, Te Whatu Ora Health New Zealand Waitaha Canterbury, Christchurch, New Zealand., Lewis DM; OpenAPS, Seattle, Washington, USA., Crocket HR; Te Huataki Waiora School of Health, Sport & Human Performance, University of Waikato, Hamilton, New Zealand., Meier RA; Department of Pediatrics, University of Otago, Christchurch, Christchurch, New Zealand., Williman JA; Department of Population Health, University of Otago, Christchurch, Christchurch, New Zealand., Sanders OJ; Department of Pediatrics, University of Otago, Christchurch, Christchurch, New Zealand.; Pediatric Department, Te Whatu Ora Health New Zealand Waitaha Canterbury, Christchurch, New Zealand., Jefferies CA; Department of Pediatric Endocrinology, Starship Children's Health, Te Whatu Ora Te Toka Tumai, Auckland, New Zealand.; Liggins Institute and Department of Pediatrics, University of Auckland, Auckland, New Zealand., Faherty AM; Department of Pediatric Endocrinology, Starship Children's Health, Te Whatu Ora Te Toka Tumai, Auckland, New Zealand., Paul RG; Te Huataki Waiora School of Health, Sport & Human Performance, University of Waikato, Hamilton, New Zealand.; Waikato Regional Diabetes Service, Te Whatu Ora Health New Zealand Waikato, Hamilton, New Zealand., Lever CS; Waikato Regional Diabetes Service, Te Whatu Ora Health New Zealand Waikato, Hamilton, New Zealand., Price SKJ; Waikato Regional Diabetes Service, Te Whatu Ora Health New Zealand Waikato, Hamilton, New Zealand., Frewen CM; Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand., Jones SD; Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand., Gunn TC; Nightscout New Zealand, Hamilton, New Zealand., Lampey C; Department of Pediatric Endocrinology, Starship Children's Health, Te Whatu Ora Te Toka Tumai, Auckland, New Zealand., Wheeler BJ; Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.; Pediatric Department, Te Whatu Ora Southern, Dunedin, New Zealand., de Bock MI; Department of Pediatrics, University of Otago, Christchurch, Christchurch, New Zealand.; Pediatric Department, Te Whatu Ora Health New Zealand Waitaha Canterbury, Christchurch, New Zealand.
Jazyk: angličtina
Zdroj: Diabetes technology & therapeutics [Diabetes Technol Ther] 2023 Apr; Vol. 25 (4), pp. 250-259. Date of Electronic Publication: 2023 Feb 28.
DOI: 10.1089/dia.2022.0484
Abstrakt: Aim: To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Methods: Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID). Most participants (69/94) used a preproduction YpsoPump ® insulin pump during the continuation phase. Analyses incorporated all 52 weeks of data, and combined between-group and within-subject differences to calculate an overall "treatment effect" of AID versus SAPT. Results: Mean time in range (TIR; 3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT (95% confidence interval [CI] 10.4 to 14.1; P  < 0.001). TIR was 56.9% (95% CI 54.2 to 59.6) with SAPT and 69.1% (95% CI 67.1 to 71.1) with AID. The treatment effect did not differ by age ( P  = 0.39) or insulin pump type ( P  = 0.37). HbA1c was 5.1 mmol/mol lower [0.5%] with AID (95% CI -6.6 to -3.6; P  < 0.001). There were no episodes of diabetic ketoacidosis or severe hypoglycemia with either treatment over the 48 weeks. Six participants (all in SAPT-AID) withdrew: three with hardware issues, two preferred SAPT, and one with infusion-site skin irritation. Conclusion: Further evaluation of the community derived automated insulin delivery (CREATE) trial to 48 weeks confirms that open-source AID is efficacious and safe with different insulin pumps, and demonstrates sustained glycemic improvements without additional safety concerns.
Databáze: MEDLINE