Revital Nimri1, Natasa Bratina2, Olga Kordonouri3, Magdalena Avbelj Stefanija2, Maryam Fath3, Torben Biester3, Ido Muller1, Eran Atlas1, Shahar Miller1, Aviel Fogel1, Moshe Phillip1,4, Thomas Danne3, Tadej Battelino2,5. 1. The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. 2. Department of Pediatric Endocrinology, Diabetes and Metabolism, University Children's Hospital, Ljubljana, Slovenia. 3. Diabetes Centre for Children and Adolescents, AUF DER BULT, Kinder- und Jugendkrankenhaus, Hannover, Germany. 4. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 5. Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
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.
RCT Entities:
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.
Authors: Gregory P Forlenza; Faye M Cameron; Trang T Ly; David Lam; Daniel P Howsmon; Nihat Baysal; Georgia Kulina; Laurel Messer; Paula Clinton; Camilla Levister; Stephen D Patek; Carol J Levy; R Paul Wadwa; David M Maahs; B Wayne Bequette; Bruce A Buckingham Journal: Diabetes Technol Ther Date: 2018-04-16 Impact factor: 6.118
Authors: Nakul Aggarwal; Mahnoor Ahmed; Sanjay Basu; John J Curtin; Barbara J Evans; Michael E Matheny; Shantanu Nundy; Mark P Sendak; Carmel Shachar; Rashmee U Shah; Sonoo Thadaney-Israni Journal: NAM Perspect Date: 2020-11-30
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