Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes
Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes
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DOI：
10.1056/nejmoa2303911
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发表时间：
2023-10-05
影响因子：
158.5
通讯作者：
Murphy, Helen R.
中科院分区：
文献类型：
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作者：
Lee, Tara T. M.;Collett, Corinne;Murphy, Helen R.
背景：混合闭环胰岛素治疗已显示出对妊娠期1型糖尿病管理的前景;方法在这项多中心对照试验中，我们在英国的9个地点随机分配糖化血红蛋白水平至少为6.5%的1型糖尿病孕妇接受标准胰岛素治疗或混合闭环治疗，两组均使用连续葡萄糖监测。主要结果是妊娠特定目标葡萄糖范围（63至140 mg/dl [3.5至7.8 mmol/L]）的时间百分比，通过连续葡萄糖监测从妊娠16周至分娩进行测量。根据意向治疗原则进行分析。关键次要结局是处于高血糖状态的时间百分比（葡萄糖水平> 140 mg/分升），目标范围内的过夜时间，糖化血红蛋白水平，结果共有124名参与者，平均（+/- SD）年龄为31.1 +/- 5.3岁，平均基线糖化血红蛋白水平为7.7 +/- 1.2%。接受随机分组。闭环组母亲血糖水平在目标范围内的平均时间百分比为68.2 +/- 10.5%，标准治疗组为55.6 +/- 12.5%（平均校正差异，10.5个百分点; 95%置信区间[CI]，7.0 - 14.0; P < 0.001）。次要结局的结果与主要结局一致;闭环组的参与者处于高血糖状态的时间少于标准治疗组（差异，-10.2个百分点; 95% CI，-13.8至-6.6）;在目标范围内的过夜时间更多（差异，12.3个百分点; 95% CI，8.3至16.2），糖化血红蛋白水平较低（差异，-0.31个百分点; 95% CI，-0.50至-0.12）。几乎没有时间处于低血糖状态。未发生与妊娠期间使用闭环治疗相关的非预期安全性问题（6例严重低血糖，标准治疗组5例;每组各1例糖尿病酮症酸中毒;闭环组发生12例器械相关不良事件，7例与闭环治疗相关）。袢疗法可显著改善妊娠合并1型糖尿病的孕妇血糖控制。
Background Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear.Methods In this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring. The primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]) as measured by continuous glucose monitoring from 16 weeks gestation until delivery. Analyses were performed according to the intention-to-treat principle. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level > 140 mg per deciliter), overnight time in the target range, the glycated hemoglobin level, and safety events.Results A total of 124 participants with a mean (+/- SD) age of 31.1 +/- 5.3 years and a mean baseline glycated hemoglobin level of 7.7 +/- 1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 68.2 +/- 10.5% in the closed-loop group and 55.6 +/- 12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; P < 0.001). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, -10.2 percentage points; 95% CI, -13.8 to -6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, -0.31 percentage points; 95% CI, -0.50 to -0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy).Conclusions Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes.