A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial

• Published in: The Lancet. Digital health 2021-11, Vol.3 (11), p.e723-e732
• Main Authors: Tsoukas, Michael A, Majdpour, Dorsa, Yale, Jean-François, Fathi, Anas El, Garfield, Natasha, Rutkowski, Joanna, Rene, Jennifer, Legault, Laurent, Haidar, Ahmad
• Format: Article
• Language: English
• Subjects: Adult; Blood Glucose - metabolism; Canada; Cross-Over Studies; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Drug Combinations; Female; Glycated Hemoglobin A - metabolism; Humans; Hypoglycemia - blood; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Insulin - administration & dosage; Insulin - therapeutic use; Insulin Infusion Systems - adverse effects; Insulin, Long-Acting - administration & dosage; Insulin, Long-Acting - therapeutic use; Islet Amyloid Polypeptide - administration & dosage; Islet Amyloid Polypeptide - therapeutic use; Male; Middle Aged; Pancreas, Artificial; Treatment Outcome; Young Adult
• ISSN: 2589-7500; 2589-7500
• DOI: 10.1016/S2589-7500(21)00139-4

For people with type 1 diabetes, there is currently no automated insulin delivery system that does not require meal input. We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input. In this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas). Adults (≥18 years) who had a clinical diagnosis of type 1 diabetes for at least 12 months, had glycated haemoglobin 12% or lower, and had been on insulin pump therapy for at least 6 months were enrolled at McGill University Health Centre, Montreal, QC, Canada. The Fiasp plus pramlintide fully closed-loop system delivered pramlintide in a basal-bolus manner with a fixed ratio of 10 μg:U relative to insulin. A research staff member counted the carbohydrate content of meals to input in the hybrid closed-loop system. Participants completed the two full-day crossover interventions in a random order allocated by a computer-generated code implementing a blocked randomisation (block size of four). The primary outcome was the percentage of time spent within the glucose target range (3·9–10·0 mmol/L), with a 6% non-inferiority margin, assessed in all participants who completed both interventions. This trial is registered with ClinicalTrials.gov, NCT03800875. Between Feb 8, 2019, and Sept 19, 2020, we enrolled 28 adults, of whom 24 completed both interventions and were included in analyses. The percentage of time spent in the target range was 74·3% (IQR 61·5–82·8) with the fully closed-loop system versus 78·1% (66·3–87·5) with the hybrid Fiasp-alone closed-loop system (paired difference 2·6%, 95% CI −2·4 to 12·2; non-inferiority p=0·28). Eight (33%) participants had at least one hypoglycaemia event (