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MD‐Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial
Author(s) -
Nimri Revital,
Bratitasa,
Kordonouri Olga,
Avbelj Stefanija Magdalena,
Fath Maryam,
Biester Torben,
Muller Ido,
Atlas Eran,
Miller Shahar,
Fogel Aviel,
Phillip Moshe,
Danne Thomas,
Battelino Tadej
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12852
Subject(s) - interquartile range , medicine , crossover study , randomized controlled trial , continuous glucose monitoring , insulin , type 1 diabetes , diabetes mellitus , zoology , gastroenterology , endocrinology , alternative medicine , pathology , biology , placebo
Aims To evaluate the safety, efficacy and need for remote monitoring of the MD‐L ogic 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/d L and percentage of nights in which mean overnight glucose levels were within 90 to 140 mg/d L . Results The median [interquartile range] percentage of time spent in hypoglycaemia was significantly lower on nights when MD‐L ogic 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‐L ogic 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.