Klemen Dovc1, Claudia Piona2, Gül Yeşiltepe Mutlu3, Natasa Bratina1, Barbara Jenko Bizjan1, Dusanka Lepej4, Revital Nimri5, Eran Atlas6, Ido Muller6, Olga Kordonouri7, Torben Biester7, Thomas Danne7, Moshe Phillip5,8, Tadej Battelino9,10. 1. Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia. 2. Pediatric Diabetes and Metabolic Disorders Unit, University City Hospital, Verona, Italy. 3. Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey. 4. Department of Pulmonology, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia. 5. The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel. 6. DreaMed Diabetes Ltd., Petah Tikva, Israel. 7. Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany. 8. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 9. Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia tadej.battelino@mf.uni-lj.si. 10. Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Abstract
OBJECTIVE: We evaluated the safety and efficacy of day-and-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: In a double-blind, randomized, crossover trial, 20 participants with type 1 diabetes on insulin pump therapy (11 females, aged 21.3 ± 2.3 years, HbA1c 7.5 ± 0.5% [58.5 ± 5.5 mmol/mol]) underwent two 27-h inpatient periods with unannounced afternoon moderate-vigorous exercise and unannounced/uncovered meals. We compared Faster-CL and Standard-CL in random order. During both interventions, the fuzzy-logic control algorithm DreaMed GlucoSitter was used. Glucose sensor data were analyzed by intention-to-treat principle with the difference (between Faster-CL and Standard-CL) in proportion of time in range 70-180 mg/dL (TIR) over 27 h as the primary end point. RESULTS: The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL (P = 0.170). The proportion of time in hypoglycemia <70 mg/dL was 0.0% for both groups. Baseline-adjusted interstitial prandial glucose increments 1 h after meals were greater in Faster-CL compared with Standard-CL (P = 0.017). The gaps between measured plasma insulin and estimated insulin-on-board levels at the beginning, at the end, and 2 h after the exercise were smaller in the Standard-CL group (P = 0.029, P = 0.003, and P = 0.004, respectively). No severe adverse events occurred. CONCLUSIONS: Fully closed-loop insulin delivery using either faster or standard insulin aspart was safe and efficient in achieving near-normal glucose concentrations outside postprandial periods. The closed-loop algorithm was better adjusted to the standard insulin aspart.
RCT Entities:
OBJECTIVE: We evaluated the safety and efficacy of day-and-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: In a double-blind, randomized, crossover trial, 20 participants with type 1 diabetes on insulin pump therapy (11 females, aged 21.3 ± 2.3 years, HbA1c 7.5 ± 0.5% [58.5 ± 5.5 mmol/mol]) underwent two 27-h inpatient periods with unannounced afternoon moderate-vigorous exercise and unannounced/uncovered meals. We compared Faster-CL and Standard-CL in random order. During both interventions, the fuzzy-logic control algorithm DreaMed GlucoSitter was used. Glucose sensor data were analyzed by intention-to-treat principle with the difference (between Faster-CL and Standard-CL) in proportion of time in range 70-180 mg/dL (TIR) over 27 h as the primary end point. RESULTS: The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL (P = 0.170). The proportion of time in hypoglycemia <70 mg/dL was 0.0% for both groups. Baseline-adjusted interstitial prandial glucose increments 1 h after meals were greater in Faster-CL compared with Standard-CL (P = 0.017). The gaps between measured plasma insulin and estimated insulin-on-board levels at the beginning, at the end, and 2 h after the exercise were smaller in the Standard-CL group (P = 0.029, P = 0.003, and P = 0.004, respectively). No severe adverse events occurred. CONCLUSIONS: Fully closed-loop insulin delivery using either faster or standard insulin aspart was safe and efficient in achieving near-normal glucose concentrations outside postprandial periods. The closed-loop algorithm was better adjusted to the standard insulin aspart.
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