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Outpatient 60‐hour day‐and‐night glucose control with dual‐hormone artificial pancreas, single‐hormone artificial pancreas, or sensor‐augmented pump therapy in adults with type 1 diabetes: A n open‐label, randomised, crossover, controlled trial
Author(s) -
Haidar Ahmad,
Messier Virginie,
Legault Laurent,
Ladouceur Martin,
RabasaLhoret Rémi
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12880
Subject(s) - artificial pancreas , hormone , medicine , endocrinology , insulin , diabetes mellitus , glucagon , pancreas , crossover study , type 2 diabetes , hormone therapy , type 1 diabetes , pathology , cancer , placebo , alternative medicine , breast cancer
Aims To assess whether the dual‐hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared to the single‐hormone (insulin alone) artificial pancreas in outpatient settings during the day and night. Material and methods In a randomized, three‐way, crossover trial we compared the dual‐hormone artificial pancreas, the single‐hormone artificial pancreas and sensor‐augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 8 AM Day 1 to 8 PM Day 3 (60 hours) in outpatient free‐living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/ L . A P value of less than .017 was regarded as significant. Results The median difference between the dual‐hormone system and the single‐hormone system was −2.3% ( P = .072) for time spent below 4.0 mmol/ L , −1.3% ( P = .017) for time below 3.5 mmol/ L , and −0.7% ( P = .031) for time below 3.3 mmol/ L . Both systems reduced ( P < .017) hypoglycaemia below 4.0, 3.5 and 3.3 mmol/ L compared to control therapy, but reductions were larger with the dual‐hormone system than with the single‐hormone system (medians −4.0% vs −3.4% for 4.0 mmol/ L ; −2.7% vs −2.2% for 3.5 mmol/ L ; and −2.2% vs −1.2% for 3.3 mmol/ L ). There were 34 hypoglycaemic events (<3.0 mmol/ L for 20 minutes) with control therapy, 14 with the single‐hormone system and 6 with the dual‐hormone system. These differences in hypoglycaemia were observed while mean glucose level was low and comparable in all interventions ( P = NS ). Conclusions The dual‐hormone artificial pancreas had the lowest risk of hypoglycaemia, but the differences were not statistically significant. Larger studies are needed.