Patients with highly unstable type 1 diabetes eligible for islet transplantation can be managed with a closed‐loop insulin delivery system: A series of N‐of‐1 randomized controlled trials

Aim To compare the efficacy of the closed‐loop Diabeloop for highly unstable diabetes (DBLHU) system with the open‐loop predictive low glucose suspend (PLGS) system in patients with highly unstable type 1 diabetes (T1D) who experience acute metabolic events. Methods DBLHU‐WP10 was an interventional,...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2021-01, Vol.23 (1), p.186-194
Main Authors: Benhamou, Pierre‐Yves, Lablanche, Sandrine, Vambergue, Anne, Doron, Maeva, Franc, Sylvia, Charpentier, Guillaume
Format: Article
Language:English
Subjects:
artificial pancreas, brittle diabetes, closed‐loop, hypoglycaemia unawareness, problematic hypoglycaemia, severe hypoglycaemia, type 1 diabetes, unstable diabetes
Clinical trials
Diabetes
Diabetes mellitus (insulin dependent)
Glucose
Hypoglycemia
Insulin
Islet cells
Life Sciences
Metabolism
Pancreas transplantation
Pancreatic islet transplantation
Transplants & implants
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Summary:Aim To compare the efficacy of the closed‐loop Diabeloop for highly unstable diabetes (DBLHU) system with the open‐loop predictive low glucose suspend (PLGS) system in patients with highly unstable type 1 diabetes (T1D) who experience acute metabolic events. Methods DBLHU‐WP10 was an interventional, controlled, randomized, open‐label study that comprised two cycles of N‐of‐1 trials (2‐of‐1 trials). Each trial consisted of two crossover 4‐week periods of treatment with either DBLHU or PLGS in randomized order. The primary outcome was the percentage of time spent in the 70‐180 mg/dL glucose range (time in range [TIR]). Results Five out of seven randomized patients completed the aggregated 2‐of‐1 trials. TIR was significantly higher with DBLHU (73.3% ± 1.7%) compared with PLGS (43.5% ± 1.7%; P 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.14214