MD-logic overnight control for 6 weeks of home use in patients with type 1 diabetes: Randomized crossover trial

Revital Nimri, Ido Muller, Eran Atlas, Shahar Miller, Aviel Fogel, Natasa Bratina, Olga Kordonouri, Tadej Battelino, Thomas Danne, Moshe Phillip

Research output: Contribution to journalArticlepeer-review

154 Scopus citations

Abstract

OBJECTIVE: We evaluated the effect of the MD-Logic system on overnight glycemic control at patients' homes. RESEARCH DESIGN AND METHODS: Twenty-four patients (aged 12-43 years; averageA1c 7.5±0.8%, 58.1±8.4mmol/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. RESULTS: 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 closedloop 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. CONCLUSIONS: 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.

Original languageEnglish
Pages (from-to)3025-3032
Number of pages8
JournalDiabetes Care
Volume37
Issue number11
DOIs
StatePublished - 1 Nov 2014
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2014 by the American Diabetes Association.

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