Tadej Battelino1,2, Revital Nimri3, Klemen Dovc4, Moshe Phillip3,5, Natasa Bratina4. 1. Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia tadej.battelino@mf.uni-lj.si. 2. Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. 3. The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel. 4. Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia. 5. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abstract
OBJECTIVE: To investigate whether predictive low glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with the sensor-augmented insulin pump in children with type 1 diabetes. RESEARCH DESIGN AND METHODS: This randomized, two-arm, parallel, controlled, two-center open-label study included 100 children and adolescents with type 1 diabetes and glycated hemoglobin A1c ≤10% (≤86 mmol/mol) and using continuous subcutaneous insulin infusion. Patients were randomly assigned to either an intervention group with PLGM features enabled (PLGM ON) or a control group (PLGM OFF), in a 1:1 ratio, all using the same type of sensor-augmented insulin pump. The primary end point was the number of hypoglycemic events below 65 mg/dL (3.6 mmol/L), based on sensor glucose readings, during a 14-day study treatment. The analysis was performed by intention to treat for all randomized patients. RESULTS: The number of hypoglycemic events below 65 mg/dL (3.6 mmol/L) was significantly smaller in the PLGM ON compared with the PLGM OFF group (mean ± SD 4.4 ± 4.5 and 7.4 ± 6.3, respectively; P = 0.008). This was also true when calculated separately for night (P = 0.025) and day (P = 0.022). No severe hypoglycemic events occurred; however, there was a significant increase in time spent above 140 mg/dL (7.8 mmol/L) in the PLGM ON group (P = 0.0165). CONCLUSIONS: The PLGM insulin suspension was associated with a significantly reduced number of hypoglycemic events. Although this was achieved at the expense of increased time in moderate hyperglycemia, there were no serious adverse effects in young patients with type 1 diabetes.
RCT Entities:
OBJECTIVE: To investigate whether predictive low glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with the sensor-augmented insulin pump in children with type 1 diabetes. RESEARCH DESIGN AND METHODS: This randomized, two-arm, parallel, controlled, two-center open-label study included 100 children and adolescents with type 1 diabetes and glycated hemoglobin A1c ≤10% (≤86 mmol/mol) and using continuous subcutaneous insulin infusion. Patients were randomly assigned to either an intervention group with PLGM features enabled (PLGM ON) or a control group (PLGM OFF), in a 1:1 ratio, all using the same type of sensor-augmented insulin pump. The primary end point was the number of hypoglycemic events below 65 mg/dL (3.6 mmol/L), based on sensor glucose readings, during a 14-day study treatment. The analysis was performed by intention to treat for all randomized patients. RESULTS: The number of hypoglycemic events below 65 mg/dL (3.6 mmol/L) was significantly smaller in the PLGM ON compared with the PLGM OFF group (mean ± SD 4.4 ± 4.5 and 7.4 ± 6.3, respectively; P = 0.008). This was also true when calculated separately for night (P = 0.025) and day (P = 0.022). No severe hypoglycemic events occurred; however, there was a significant increase in time spent above 140 mg/dL (7.8 mmol/L) in the PLGM ON group (P = 0.0165). CONCLUSIONS: The PLGM insulin suspension was associated with a significantly reduced number of hypoglycemic events. Although this was achieved at the expense of increased time in moderate hyperglycemia, there were no serious adverse effects in young patients with type 1 diabetes.
Authors: Sue A Brown; Boris P Kovatchev; Dan Raghinaru; John W Lum; Bruce A Buckingham; Yogish C Kudva; Lori M Laffel; Carol J Levy; Jordan E Pinsker; R Paul Wadwa; Eyal Dassau; Francis J Doyle; Stacey M Anderson; Mei Mei Church; Vikash Dadlani; Laya Ekhlaspour; Gregory P Forlenza; Elvira Isganaitis; David W Lam; Craig Kollman; Roy W Beck Journal: N Engl J Med Date: 2019-10-16 Impact factor: 91.245
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