Outpatient glycemic control with a bionic pancreas in type 1 diabetes.
Outpatient glycemic control with a bionic pancreas in type 1 diabetes.
复制标题
DOI：
10.1056/nejmoa1314474
复制
发表时间：
2014-07-24
期刊：
影响因子：
--
通讯作者：
Damiano ER
中科院分区：
文献类型：
--
作者：
Russell SJ;El-Khatib FH;Sinha M;Magyar KL;McKeon K;Goergen LG;Balliro C;Hillard MA;Nathan DM;Damiano ER
自动化血糖管理的安全性和有效性还没有在不受限制的门诊条件下的多天研究中进行测试。在两项具有相似但不同设计的随机顺序交叉研究中，我们比较了20名成人和32名青少年1型糖尿病患者5天的血糖控制与可穿戴的、双激素的、自动化的“仿生”胰腺(仿生-胰腺期)和血糖控制与胰岛素泵(控制期)的5天。仿生胰腺的自动自适应算法从连续的血糖监测仪接收数据，以控制胰岛素和胰高血糖素的皮下输送。在成人中，在5天的仿生胰腺期间，平均血糖水平为138毫克/分升(7.7 mmol/升)，低血糖水平的平均时间百分比(<；70 mg/分升[3.9 mmol/升])为4.8%。在由仿生胰腺自动适应1天后，连续监测的平均(±SD)血糖水平低于控制期的平均水平(133±13比159±30 mg/升[7.4±0.7vs.8.8±1.7 mmoL/L]，P<；0.001)，低血糖读数的时间百分比也较低(4.1%比7.3%，P=0.001)。在青少年中，在仿生胰腺期间的平均血糖水平也低于对照组(138±18vs.157±27 mg/升[7.7±1.0vs.8.7±1.5mmol/L]，P=0.004)，但两个时期的低血糖读数的百分比相似(分别为6.1%和7.6%；P=0.23)。在仿生胰腺期间，青少年低血糖干预的平均频率低于对照组(每1.6d一次，而对照组为每0.8d一次，P<；0.001)。与胰岛素泵相比，在成人和青少年1型糖尿病患者中，可穿戴的、自动的、双激素的仿生胰腺改善了平均血糖水平，并减少了低血糖发作的频率。(由国家糖尿病、消化和肾脏疾病研究所等资助；ClinicalTrials.gov编号，NCT01762059和NCT01833988。)
The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions. In two random-order, crossover studies with similar but distinct designs, we compared glycemic control with a wearable, bihormonal, automated, “bionic” pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus. The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon. Among the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (<70 mg per deciliter [3.9 mmol per liter]) was 4.8%. After 1 day of automatic adaptation by the bionic pancreas, the mean (±SD) glucose level on continuous monitoring was lower than the mean level during the control period (133±13 vs. 159±30 mg per deciliter [7.4±0.7 vs. 8.8±1.7 mmol per liter], P<0.001) and the percentage of time with a low glucose reading was lower (4.1% vs. 7.3%, P = 0.01). Among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter [7.7±1.0 vs. 8.7±1.5 mmol per liter], P = 0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P = 0.23). The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P<0.001). As compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01762059 and NCT01833988.)