OBJECTIVE To determine efficacy and safety of intrapartum and early postpartum advanced hybrid closed-loop (AHCL) therapy compared with standard insulin therapy in pregnant women with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS CRISTAL was a double-arm, open-label, randomized controlled trial performed in Belgium and the Netherlands that assigned 95 pregnant participants with T1D 1:1 to a MiniMed 780G AHCL system (n = 46) or standard insulin therapy (n = 49). This prespecified, secondary observational analysis focused on differences in glycemic control and safety outcomes between participants from the original AHCL group who continued AHCL intrapartum (n = 27) and/or early postpartum (n = 37, until hospital discharge) and those from the original standard insulin therapy group using standard insulin therapy intrapartum (n = 45) and/or early postpartum (n = 34). RESULTS Of the 43 and 46 participants in the AHCL and standard insulin therapy groups, respectively, completing the trial, 27 (62.8%) in the AHCL group continued AHCL and 45 in the standard insulin therapy group (97.8%) continued standard insulin therapy intrapartum. Compared with standard insulin therapy, intrapartum AHCL was associated with more time in range 3.5–7.8 mmol/L (71.5 ± 17.7% vs. 63.1 ± 17.0%, P = 0.030) and numerically lower time above range >7.8 mmol/L (27.3 ± 17.4% vs. 35.3 ± 17.5%, P = 0.054), without increases in time below range <3.5 mmol/L (1.1 ± 2.4% vs. 1.5 ± 2.3%, P = 0.146). Early postpartum, 37 (86.0%) participants randomized to AHCL continued AHCL, with a median increase in insulin-to-carbohydrate ratios of 67% (interquartile range −14 to 126). Similar tight glycemic control (3.9–10.0 mmol/L: 86.8 ± 6.7% vs. 83.8 ± 8.1%, P = 0.124) was observed with AHCL versus standard insulin therapy. No severe hypoglycemia or diabetic ketoacidosis was reported in either group. CONCLUSIONS AHCL is effective in maintaining tight glycemic control intrapartum and early postpartum and can be safely continued during periods of rapidly changing insulin requirements.

中文翻译：

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1 型糖尿病女性产时和产后早期高级混合闭环疗法与标准胰岛素治疗的比较：来自 CRISTAL 随机对照试验的二次观察分析


目的 确定产时和产后早期高级混合闭环 （AHCL） 治疗与标准胰岛素治疗相比对 1 型糖尿病 （T1D） 孕妇的疗效和安全性。研究设计和方法 CRISTAL 是一项在比利时和荷兰进行的双臂、开放标签、随机对照试验，将 95 名 T1D 孕妇以 1：1 的比例分配到 MiniMed 780G AHCL 系统 （n = 46） 或标准胰岛素治疗 （n = 49） 组。这项预先指定的二次观察分析侧重于原始 AHCL 组参与者在产时 （n = 27） 和/或产后早期 （n = 37，直至出院） 与原始标准胰岛素治疗组参与者在血糖控制和安全性结果方面的差异使用标准胰岛素治疗产时 （n = 45） 和/或产后早期 （n = 34）。结果 在 AHCL 和标准胰岛素治疗组的 43 名和 46 名参与者中，分别完成试验，AHCL 组 27 名 （62.8%） 继续 AHCL，标准胰岛素治疗组 45 名 （97.8%） 继续标准胰岛素治疗产期。与标准胰岛素治疗相比，产时 AHCL 与 3.5-7.8 mmol/L 范围内的时间更长相关 （71.5 ± 17.7% vs. 63.1 ± 17.0%，P = 0.030） 和数值上较低的时间 >7.8 mmol/L 范围 （27.3 ± 17.4% vs. 35.3 ± 17.5%，P = 0.054），低于 <3.5 mmol/L 的时间没有增加 （1.1 ± 2.4% vs. 1.5 ± 2.3%，P = 0.146）。产后早期，37 名 （86.0%） 参与者随机分配到 AHCL 组，继续进行 AHCL，胰岛素与碳水化合物比率的中位数增加 67%（四分位距 -14 至 126）。类似的严格血糖控制（3.9-10.0 mmol/L：86.8 ± 6.7% vs. 83.8 ± 8.1%，P = 0。124） 与 AHCL 与标准胰岛素治疗相比观察到。两组均未报告严重低血糖或糖尿病酮症酸中毒。结论 AHCL 可有效维持产时和产后早期的严格血糖控制，并且可以在胰岛素需求快速变化的时期安全地继续进行。