Night glucose control with MD-Logic artificial pancreas in home setting: A single blind, randomized crossover trial-interim analysis: A single blind, randomized crossover trial-interim analysis

Background: Artificial pancreas (AP) systems have shown an improvement in glucose control and a reduced risk of nocturnal hypoglycemia under controlled conditions but remain to be evaluated under daily-life conditions. Objective: To assess the feasibility, safety, and efficacy of the MD-Logic AP in controlling nocturnal glucose levels in the patient's home. Methods: Two-arm study, each covering four consecutive nights comparing the MD-Logic AP ('closed-loop' arm) with sensor-augmented pump therapy ('control' arm). Fifteen patients (mean age 19±10.4yr, A1c 7.5±0.5% or 58±5.9 mmol/mol, diabetes duration 9.9±8.2yr) were randomly assigned either to 'Group A' (first 'closed-loop', then 'control' arm) or to 'Group B' (vice versa). Investigators were masked to treatment intervention. Primary endpoints were the time spent with glucose levels below 70mg/dL and the percentage of nights in which the mean overnight glucose levels were within 90-140mg/dL. Endpoint analyses were based on unmodified sensor glucose readings of the four study nights. Results: Time of glucose levels spent below 70mg/dL was significantly shorter on the closed-loop nights than on control nights, median and interquartile range 3.8 (0, 11.6) and 48.7 (0.6, 67.9) min, respectively; p=0.0034. The percentage of individual nights in which mean overnight glucose level was within 90-140mg/dL was 67 (33, 88), and 50 (25, 75), under closed-loop and control nights, respectively, with no statistical difference. Secondary endpoint analyses demonstrated significant improvements in hypoglycemia parameters. No serious adverse events were reported. Conclusion: This interim analysis demonstrates the feasibility, safety, and efficiency of the MD-Logic AP system in home use, and demonstrates an improvement over sensor-augmented pump therapy. (ClinicalTrials.gov identifier NCT01726829). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.