Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15.
BACKGROUND: The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.).
背景：在不受限制的门诊条件下，多日研究尚未检验自动化血糖管理的安全性和有效性。
方法：在两项随机交叉研究中，设计相似但有区别，我们比较了可穿戴、双激素、自动化“仿生”胰腺（仿生胰腺期）与胰岛素泵（对照期）控制血糖 5 天的情况，共有 20 名成年和 32 名青少年 1 型糖尿病患者参与。仿生胰腺的自动自适应算法从连续血糖监测仪接收数据，以控制皮下胰岛素和胰高血糖素的输送。
结果：在成年人中，仿生胰腺 5 天期间的平均血浆葡萄糖水平为 138mg/分升（7.7mmol/L），低血糖时间（<70mg/分升[3.9mmol/L]）的平均百分比为 4.8%。在仿生胰腺自动适应 1 天后，连续监测的平均（±SD）血糖水平低于对照期间的平均水平（133±13 vs. 159±30mg/分升[7.4±0.7 vs. 8.8±1.7mmol/L]，P<0.001），低血糖读数的时间百分比也较低（4.1% vs. 7.3%，P=0.01）。在青少年中，仿生胰腺期间的平均血浆葡萄糖水平也低于对照期间（138±18 vs. 157±27mg/分升[7.7±1.0 vs. 8.7±1.5mmol/L]，P=0.004），但两个时期的低血糖读数时间百分比相似（分别为 6.1%和 7.6%，P=0.23）。青少年在仿生胰腺期间低血糖干预的平均频率低于对照期间（每 1.6 天一次 vs. 每 0.8 天一次，P<0.001）。
结论：与胰岛素泵相比，可穿戴、自动化、双激素仿生胰腺改善了成年和青少年 1 型糖尿病患者的平均血糖水平，且低血糖发作频率更低。（由美国国立卫生研究院糖尿病、消化和肾脏疾病研究所等资助；临床试验.gov 编号，NCT01762059 和 NCT01833988）。
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