Safety, efficacy and glucose turnover of reduced prandial boluses during closed-loop therapy in adolescents with type 1 diabetes: a randomized clinical trial.
Safety, efficacy and glucose turnover of reduced prandial boluses during closed-loop therapy in adolescents with type 1 diabetes: a randomized clinical trial.
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DOI：
10.1111/dom.12549
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发表时间：
2015-12
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影响因子：
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通讯作者：
Hovorka R
中科院分区：
文献类型：
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作者：
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;Hovorka R
目的：评估青少年1型糖尿病(T1D)患者减少餐后胰岛素推注的封闭式饮食通告期间的安全性、有效性和葡萄糖转换。我们进行了一项随机交叉研究，比较了标准餐胰岛素推注的闭环治疗和餐后推注减少25%的闭环治疗。8名患有T1D的青少年[3名男性，平均(标准差)年龄15.9(1.5)岁，糖化血红蛋白74(17)mmol/mol；中位数(四分位数范围)每日总剂量0.9(0.7，1.1)IU/kg/d]在两次长达36小时的访问中进行了研究。按随机顺序，受试者接受标准胰岛素丸或减量胰岛素丸加主餐(50-80克碳水化合物)，但不加零食(15-30克碳水化合物)的闭环治疗。稳定标记示踪稀释法测定总葡萄糖表观(Ra_TOTAL)和葡萄糖处置(Rd)。两组在目标时间(四分位数范围)的中位数(四分位数范围)相似[74(66，84)%vs 80(65，96)%；p=0.87]，高于10 mm ol/L的时间[21.8(16.3，33.5)%vs 18.0(4.1，34.2)%；p=0.87]和低于3.9 mm ol/L的时间[0(0，1.5)%vs 0(0，1.8)%；p=0.88]。两次干预期间平均血糖水平相同[8.4(0.9)mmol/L；p=0.98]。在标准剂量的闭环治疗中，餐后1.5h出现1次低血糖。总体胰岛素释放减少[61.9(55.2，75.0)对72.5(63.6，80.3)IU；p=0.0 1]，并导致平均血浆胰岛素浓度降低[186(171,260)vs252(198,336)pmol/L；p=0.002]。过夜也记录了较低的血胰岛素水平[160(136,192)pmol/L比191(133,252)pmol/L；p=0.01，共住一晚]。RA_TOTAL与RD相似[26.3(21.9，28.0)vs 25.4(21.0，29.2)µmol/kg/min；p=0.19]，RD[25.8(21.0，26.9)vs 25.2(21.2，28.8)µmol/kg/min；p=0.46]。在闭环治疗期间减少25%的膳食推注，在降低总体血浆胰岛素水平的同时，保持了对患有T1D的青少年的相似的血糖控制。目前尚不清楚减少25%餐后剂量的闭环治疗是否能预防餐后低血糖。
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). 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). 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]. 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.