We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart (‘closed-loop’) with standard insulin therapy and a masked continuous glucose monitor (‘control’) in random order. The primary endpoint was time in target glucose range (5.6–10.0 mmol l −1 ). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0 mmol l −1 ; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0–22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l −1 ; P = 0.003). Time in hypoglycemia (<3.9 mmol l −1 ) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0–0.4%) versus 0.2 (0.0–0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775. A new randomized, crossover clinical trial testing rapid-acting insulin aspart delivered in a closed-loop system compared with standard care demonstrates increased time in range in patients with type 2 diabetes who require dialysis in the outpatient setting.
【저자키워드】 type 2 diabetes, End-stage renal disease, 【초록키워드】 Efficacy, clinical trial, therapy, Trial, Open-label, dialysis, Randomized, Patient, age, women, insulin, hypoglycemia, Glucose, primary endpoint, Insulin therapy, Trial registration, 95% CI, standard care, average, participant, mean difference, random, MONITOR, Cambridge, men, time, event, occurred, proportion, evaluated, reduced, median, faster, was reduced, diabete, adult outpatient, IQR, type 2 diabete, 【제목키워드】 Trial, Open-label, Randomized, automated, Glucose, Insulin therapy, type 2 diabete,