MD‐Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial

Aims To evaluate the safety, efficacy and need for remote monitoring of the MD‐Logic closed‐loop system during short‐term overnight use at home. Methods Seventy‐five patients (38 male; aged 10‐54 years; average A1c, 7.8% ± 0.7%, 61.8 ± 7.2 mmol/mol) were enrolled from 3 clinical sites. Patients were randomly assigned to participate in 2 overnight crossover periods, each including 4 consecutive nights, 1 under closed‐loop control and 1 under sensor‐augmented pump (SAP) therapy in the patient's home. Both study arms were supervised using a remote‐monitoring system in a blinded manner. Primary endpoints were time spent with glucose levels below 70 mg/dL and percentage of nights in which mean overnight glucose levels were within 90 to 140 mg/dL. Results The median [interquartile range] percentage of time spent in hypoglycaemia was significantly lower on nights when MD‐Logic was used, compared to SAP therapy (2.07 [0, 4.78] and 2.6 [0, 10.34], respectively; P = .004) and the percentage of individual nights with a mean overnight glucose level in target was significantly greater (75 [42, 75] and 50 [25,75], respectively; P = .008). The time spent in target range was increased by a median of 28% (P = .001), with the same amount of insulin (10.69 [7.28, 13.94] and 10.41[6.9, 14.07], respectively; P = .087). The remote monitoring triggered calls for hypoglycaemia at twice the rate during SAP therapy compared to closed‐loop control (62 and 29, respectively; P = .002). Conclusions The MD‐Logic system demonstrated a safe and efficient profile during overnight use by children, adolescents and adults with type 1 diabetes and, therefore, provides an effective means of mitigating the risk of nocturnal hypoglycaemia.