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Open-Source Automated Insulin Delivery in Type 1 Diabetes.
Burnside, Mercedes J; Lewis, Dana M; Crocket, Hamish R; Meier, Renee A; Williman, Jonathan A; Sanders, Olivia J; Jefferies, Craig A; Faherty, Ann M; Paul, Ryan G; Lever, Claire S; Price, Sarah K J; Frewen, Carla M; Jones, Shirley D; Gunn, Tim C; Lampey, Christina; Wheeler, Benjamin J; de Bock, Martin I.
Affiliation
  • Burnside MJ; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Lewis DM; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Crocket HR; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Meier RA; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Williman JA; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Sanders OJ; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Jefferies CA; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Faherty AM; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Paul RG; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Lever CS; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Price SKJ; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Frewen CM; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Jones SD; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Gunn TC; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Lampey C; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • Wheeler BJ; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
  • de Bock MI; From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, Univers
N Engl J Med ; 387(10): 869-881, 2022 09 08.
Article in En | MEDLINE | ID: mdl-36069869
ABSTRACT

BACKGROUND:

Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.

METHODS:

In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 11 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial).

RESULTS:

A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues.

CONCLUSIONS:

In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).
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Full text: 1 Database: MEDLINE Main subject: Blood Glucose / Infusion Pumps / Diabetes Mellitus, Type 1 / Hypoglycemic Agents / Insulin Type of study: Clinical_trials Limits: Adolescent / Adult / Aged / Child / Humans / Middle aged Country/Region as subject: Oceania Language: En Year: 2022 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Blood Glucose / Infusion Pumps / Diabetes Mellitus, Type 1 / Hypoglycemic Agents / Insulin Type of study: Clinical_trials Limits: Adolescent / Adult / Aged / Child / Humans / Middle aged Country/Region as subject: Oceania Language: En Year: 2022 Type: Article