1. Safety, efficacy and glucose turnover of reduced prandial boluses during closed-loop therapy in adolescents with type 1 diabetes: a randomized clinical trial.
- Author
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Elleri D, Biagioni M, Allen JM, Kumareswaran K, Leelarathna L, Caldwell K, Nodale M, Wilinska ME, Haidar A, Calhoun P, Kollman C, Jackson NC, Umpleby AM, Acerini CL, Dunger DB, and Hovorka R
- Subjects
- Adolescent, Algorithms, Cross-Over Studies, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 metabolism, Drug Administration Schedule, England epidemiology, Female, Glycemic Load, Humans, Hyperinsulinism chemically induced, Hyperinsulinism epidemiology, Hyperinsulinism prevention & control, Hypoglycemia chemically induced, Hypoglycemia epidemiology, Hypoglycemic Agents adverse effects, Hypoglycemic Agents blood, Hypoglycemic Agents therapeutic use, Injections, Subcutaneous, Insulin adverse effects, Insulin blood, Insulin therapeutic use, Insulin Resistance, Male, Meals, Risk, Blood Glucose analysis, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia prevention & control, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems, Monitoring, Physiologic
- Abstract
Aims: To evaluate safety, efficacy and glucose turnover during closed-loop with meal announcement using reduced prandial insulin boluses in adolescents with type 1 diabetes (T1D)., Methods: We conducted a randomized crossover study comparing closed-loop therapy with standard prandial insulin boluses versus closed-loop therapy with prandial boluses reduced by 25%. Eight adolescents with T1D [3 males; mean (standard deviation) age 15.9 (1.5) years, glycated haemoglobin 74 (17) mmol/mol; median (interquartile range) total daily dose 0.9 (0.7, 1.1) IU/kg/day] were studied on two 36-h-long visits. In random order, subjects received closed-loop therapy with either standard or reduced insulin boluses administered with main meals (50-80 g carbohydrates) but not with snacks (15-30 g carbohydrates). Stable-label tracer dilution methodology measured total glucose appearance (Ra_total) and glucose disposal (Rd)., Results: The median (interquartile range) time spent in target (3.9-10 mmol/l) was similar between the two interventions [74 (66, 84)% vs 80 (65, 96)%; p = 0.87] as was time spent above 10 mmol/l [21.8 (16.3, 33.5)% vs 18.0 (4.1, 34.2)%; p = 0.87] and below 3.9 mmol/l [0 (0, 1.5)% vs 0 (0, 1.8)%; p = 0.88]. Mean plasma glucose was identical during the two interventions [8.4 (0.9) mmol/l; p = 0.98]. Hypoglycaemia occurred once 1.5 h post-meal during closed-loop therapy with standard bolus. Overall insulin delivery was lower with reduced prandial boluses [61.9 (55.2, 75.0) vs 72.5 (63.6, 80.3) IU; p = 0.01] and resulted in lower mean plasma insulin concentration [186 (171, 260) vs 252 (198, 336) pmol/l; p = 0.002]. Lower plasma insulin was also documented overnight [160 (136, 192) vs 191 (133, 252) pmol/l; p = 0.01, pooled nights]. Ra_total was similar [26.3 (21.9, 28.0) vs 25.4 (21.0, 29.2) µmol/kg/min; p = 0.19] during the two interventions as was Rd [25.8 (21.0, 26.9) vs 25.2 (21.2, 28.8) µmol/kg/min; p = 0.46]., Conclusions: A 25% reduction in prandial boluses during closed-loop therapy maintains similar glucose control in adolescents with T1D whilst lowering overall plasma insulin levels. It remains unclear whether closed-loop therapy with a 25% reduction in prandial boluses would prevent postprandial hypoglycaemia., (© 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2015
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