MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial

• Published in: Diabetes care Vol. 37; no. 11; pp. 3025 - 3032
• Main Authors: Nimri, Revital, Muller, Ido, Atlas, Eran, Miller, Shahar, Fogel, Aviel, Bratina, Natasa, Kordonouri, Olga, Battelino, Tadej, Danne, Thomas, Phillip, Moshe
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01.11.2014
• Subjects: Adolescent; Adult; Biosensors; Blood Glucose - drug effects; Child; Clinical trials; Closed loop systems; Cross-Over Studies; Diabetes; Diabetes Mellitus, Type 1 - drug therapy; Female; Glucose; Humans; Hyperglycemia - drug therapy; Hyperglycemia - epidemiology; Hypoglycemia - epidemiology; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Insulin - administration & dosage; Insulin - therapeutic use; Insulin Infusion Systems; Male; Therapy; Young Adult
• ISSN: 0149-5992; 1935-5548; 1935-5548
• DOI: 10.2337/dc14-0835

We evaluated the effect of the MD-Logic system on overnight glycemic control at patients' homes. Twenty-four patients (aged 12-43 years; average A1c 7.5 ± 0.8%, 58.1 ± 8.4 mmol/mol) were randomly assigned to participate in two overnight crossover periods, each including 6 weeks of consecutive nights: one under closed loop and the second under sensor-augmented pump (SAP) therapy at patients' homes in real-life conditions. The primary end point was time spent with sensor glucose levels below 70 mg/dL (3.9 mmol/L) overnight. Closed-loop nights significantly reduced time spent in hypoglycemia (P = 0.02) and increased the percentage of time spent in the target range of 70-140 mg/dL (P = 0.003) compared with nights when the SAP therapy was used. The time spent in substantial hyperglycemia above 240 mg/dL was reduced by a median of 52.2% (interquartile range [IQR] 4.8, 72.9%; P = 0.001) under closed-loop control compared with SAP therapy. Overnight total insulin doses were lower in the closed-loop nights compared with the SAP nights (P = 0.04). The average daytime glucose levels after closed-loop operation were reduced by a median of 10.0 mg/dL (IQR -2.7, 19.2; P = 0.017) while lower total insulin doses were used (P = 0.038). No severe adverse events occurred during closed-loop control; there was a single event of severe hypoglycemia during a control night. The long-term home use of automated overnight insulin delivery by the MD-Logic system was found to be a feasible, safe, and an effective tool to reduce nocturnal hypoglycemia and improve overnight glycemic control in subjects with type 1 diabetes.