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. Issue 1 (22nd October 2020)

• Record Type: Journal Article
• Authors: Benhamou, Pierre‐Yves; Lablanche, Sandrine; Vambergue, Anne; Doron, Maeva; Franc, Sylvia; Charpentier, Guillaume
• Is Part Of: Diabetes, obesity & metabolism. Volume 23:Issue 1(2021)
• Page Start: 186
• Page End: 194
• Publication Date: 2020-10-22
• Subjects: artificial pancreas, brittle diabetes, closed‐loop, hypoglycaemia unawareness, problematic hypoglycaemia, severe hypoglycaemia, type 1 diabetes, unstable diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14214
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: 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 < .0001). The percentage of time below 70 mg/dL was significantly lower with DBLHU (0.9% ± 0.4%) versus PLGS (3.7% ± 0.4%; P < .0001). DBLHU was also significantly superior to PLGS in reducing hyperglycaemic excursions and improving almost all other secondary outcomes, including glucose variability and satisfaction score. No adverse event could be related to the experimental treatment. Conclusions: DBLHU was superior to PLGS in improving the metabolic control of patients with highly unstable T1D who require an islet or pancreas transplant but who either have a contraindication or refuse to consent.