Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial,Diabetes Care

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Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial
Diabetes Care ( IF 16.2 ) Pub Date : 2018-07-01 , DOI: 10.2337/dc17-2534
Zoe A. Stewart _{1,

2} , Malgorzata E. Wilinska ₁ , Sara Hartnell ₂ , Leanne K. O’Neil ₃ , Gerry Rayman ₄ , Eleanor M. Scott ₅ , Katharine Barnard ₆ , Conor Farrington ₇ , Roman Hovorka ₁ , Helen R. Murphy _{1,

2,

3,

8}

Affiliation

OBJECTIVE Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery.

RESEARCH DESIGN AND METHODS We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA_1c 8.0% [1.1], and BMI 26.6 [4.4] kg/m²) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63–140 mg/dL).

RESULTS The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI −4.1 to 8.3]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 [range 1–17] vs. 12.5 [1–53] over 28 days; P = 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%; P = 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%; P = 0.03) and low blood glucose index (1.0 vs. 1.4; P = 0.01) were lower. Less nocturnal hypoglycemia (2300–0700 h) during closed-loop therapy (1.1 vs. 2.7%; P = 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%; P = 0.06) were found.

CONCLUSIONS Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer-duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes.

中文翻译：

广泛的1型糖尿病孕妇的日夜闭环胰岛素输送：随机对照试验

目的尽管技术进步，在1型糖尿病（T1D）妊娠中，最佳的血糖控制仍然难以实现，新生儿并发症仍然普遍存在。我们的目的是检查昼夜闭环胰岛素递送的安全性，有效性和长期可行性。

研究设计与方法我们招募了16名孕妇（平均[SD]：年龄32.8 [5.0]岁，T1D持续时间19.4 [10.2]年，HbA _1c 8.0％[1.1]，BMI 26.6 [4.4] kg / m ²）至开放标签的随机交叉试验。参与者完成了28天的闭环和传感器增强泵（SAP）胰岛素输送，并且需要经过一个冲洗期。之后，参与者可以在产后6周内继续使用闭环系统。主要终点是血糖水平在目标范围内（63–140 mg / dL）的时间比例。

结果在闭环和SAP胰岛素输送过程中，目标时间内葡萄糖水平所占的时间比例相当（62.3对60.1％[95％CI -4.1至8.3]；P = 0.47）。高血糖的平均血糖和花费的时间> 140 mg / dL也没有差异（分别为131.4 vs. 131.4 mg / dL [ P = 0.85]和36.6 vs. 36.1％[ P = 0.86]）。在闭环期间，发生降血糖事件的次数较少（28天中位数8 [范围1–17]比12.5 [1-53]；P = 0.04），<63 mg / dL的时间更少（1.6比2.7％；P = 0.04）。P = 0.02）。低血糖<50 mg / dL（0.24 vs.0.47％; P = 0.03）和低血糖指数（1.0 vs. 1.4; P= 0.01）更低。发现闭环治疗期间的夜间低血糖事件较少（2300-0700小时）（1.1 vs. 2.7％；P = 0.008），并且目标的过夜时间有增加趋势（67.7 vs. 60.6％；P = 0.06）。