Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
BMJ. 2011 Apr 13;342:d1855. doi: 10.1136/bmj.d1855.
To compare the safety and efficacy of overnight closed loop delivery of insulin (artificial pancreas) with conventional insulin pump therapy in adults with type 1 diabetes.
Two sequential, open label, randomised controlled crossover, single centre studies.
Clinical research facility.
24 adults (10 men, 14 women) with type 1 diabetes, aged 18-65, who had used insulin pump therapy for at least three months: 12 were tested after consuming a medium sized meal and the other 12 after consuming a larger meal accompanied by alcohol.
During overnight closed loop delivery, sensor measurements of glucose were fed into a computer algorithm, which advised on insulin pump infusion rates at 15 minute intervals. During control nights, conventional insulin pump settings were applied. One study compared closed loop delivery of insulin with conventional pump therapy after a medium sized evening meal (60 g of carbohydrates) at 1900, depicting the scenario of "eating in." The other study was carried out after a later large evening meal (100 g of carbohydrates) at 2030, accompanied by white wine (0.75 g/kg ethanol) and depicted the scenario of "eating out."
The primary outcome was the time plasma glucose levels were in target (3.91-8.0 mmol/L) during closed loop delivery and a comparable control period. Secondary outcomes included pooled data analysis and time plasma glucose levels were below target (≤ 3.9 mmol/L).
For the eating in scenario, overnight closed loop delivery of insulin increased the time plasma glucose levels were in target by a median 15% (interquartile range 3-35%), P = 0.002. For the eating out scenario, closed loop delivery increased the time plasma glucose levels were in target by a median 28% (2-39%), P = 0.01. Analysis of pooled data showed that the overall time plasma glucose was in target increased by a median 22% (3-37%) with closed loop delivery (P < 0.001). Closed loop delivery reduced overnight time spent hypoglycaemic (plasma glucose ≤ 3.9 mmol/L) by a median 3% (0-20%), P=0.04, and eliminated plasma glucose concentrations below 3.0 mmol/L after midnight.
These two small crossover trials suggest that closed loop delivery of insulin may improve overnight control of glucose levels and reduce the risk of nocturnal hypoglycaemia in adults with type 1 diabetes. Trial registration ClinicalTrials.gov NCT00910767 and NCT00944619.
比较 1 型糖尿病成人患者使用胰岛素夜间闭环输送（人工胰腺）与传统胰岛素泵治疗的安全性和有效性。
两项连续、开放标签、随机对照交叉、单中心研究。
临床研究设施。
24 名年龄在 18-65 岁之间的 1 型糖尿病成人（10 名男性，14 名女性），使用胰岛素泵治疗至少 3 个月：12 名在食用中等大小的餐后进行测试，另 12 名在食用较大的餐后且伴有酒精摄入时进行测试。
在夜间闭环输送期间，葡萄糖的传感器测量值被输入到计算机算法中，该算法每隔 15 分钟就胰岛素泵输注率提出建议。在对照夜间，应用传统的胰岛素泵设置。一项研究比较了在晚上 7 点（60 克碳水化合物）进食中等大小的晚餐后，闭环输送胰岛素与传统泵治疗的情况，描绘了“用餐”的场景。另一项研究是在晚上 8 点 30 分（100 克碳水化合物）进食大餐后进行的，伴有白葡萄酒（0.75 克/公斤乙醇），描绘了“外出就餐”的场景。
主要结果是夜间闭环输送期间和可比对照期间血糖水平在目标范围内（3.91-8.0mmol/L）的时间。次要观察指标包括汇总数据分析和血糖水平低于目标值（≤3.9mmol/L）的时间。
在“用餐”场景中，夜间闭环输送胰岛素使血糖水平达标时间中位数增加 15%（四分位距 3-35%），P=0.002。在“外出就餐”场景中，闭环输送使血糖水平达标时间中位数增加 28%（2-39%），P=0.01。汇总数据分析显示，闭环输送使血糖总体达标时间中位数增加 22%（3-37%）（P<0.001）。闭环输送使夜间低血糖（血糖≤3.9mmol/L）时间中位数减少 3%（0-20%），P=0.04，并消除了午夜后血糖浓度低于 3.0mmol/L 的情况。
这两项小型交叉试验表明，闭环输送胰岛素可能改善 1 型糖尿病成人患者的夜间血糖控制，降低夜间低血糖风险。试验注册ClinicalTrials.gov NCT00910767 和 NCT00944619。
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