MD‐Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial. Issue 4 (19th January 2017)

• Record Type: Journal Article
• 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
• Is Part Of: Diabetes, obesity & metabolism. Volume 19:Issue 4(2017)
• Page Start: 553
• Page End: 561
• Publication Date: 2017-01-19
• Subjects: closed‐loop -- MD‐Logic -- nocturnal hypoglycaemia -- remote‐monitoring -- type 1; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12852
• Languages: English
• ISSNs: 1462-8902

Abstract

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/dL and percentage of nights in which mean overnight glucose levels were within 90 to 140 mg/dL. 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.