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- Title
MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial.
- Authors
Nimri, Revital; Bratina, Natasa; Kordonouri, Olga; Avbelj Stefanija, Magdalena; Fath, Maryam; Biester, Torben; Muller, Ido; Atlas, Eran; Miller, Shahar; Fogel, Aviel; Phillip, Moshe; Danne, Thomas; Battelino, Tadej
- Abstract
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/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-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.
- Subjects
CLOSED loop systems; REMOTE control; HYPOGLYCEMIA in children; TYPE 1 diabetes; AUGMENTED reality; THERAPEUTICS
- Publication
Diabetes, Obesity & Metabolism, 2017, Vol 19, Issue 4, p553
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12852