Safety, efficacy and XXXX turnover of reduced prandial boluses during closed-loop therapy in adolescents with @entity1723 : a randomized clinical trial.

@entity2690 @entity4053 @entity1723 @entity413 @entity3363
AIMS: To evaluate safety, efficacy and @entity413 turnover during closed-loop with meal announcement using reduced prandial @entity2690 boluses in adolescents with @entity1723 ( @entity1723 ). METHODS: We conducted a randomized crossover study comparing closed-loop therapy with standard prandial @entity2690 boluses versus closed-loop therapy with prandial boluses reduced by 25%. Eight adolescents with @entity1723 [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 @entity2690 boluses administered with main meals (50-80 g @entity3363 ) but not with snacks (15-30 g @entity3363 ). Stable-label tracer dilution methodology measured total @entity413 appearance (Ra_total) and @entity413 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 @entity413 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 @entity2690 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 @entity2690 concentration [186 (171, 260) vs 252 (198, 336) pmol/l; p = 0.002]. Lower plasma @entity2690 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)   mol/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)   mol/kg/min; p = 0.46]. CONCLUSIONS: A 25% reduction in prandial boluses during closed-loop therapy maintains similar @entity413 control in adolescents with @entity1723 whilst lowering overall plasma @entity2690 levels. It remains unclear whether closed-loop therapy with a 25% reduction in prandial boluses would prevent @entity4053 .
