To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes.

This open-label, randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range (TIR; 3.9–10.0 mmol/L).

There were 30 participants (mean age 67 [SD 5] years), with median type 1 diabetes duration of 38 years (interquartile range [IQR] 20–47), randomized (n = 15 to each sequence); all completed the trial. The mean TIR was 75.2% (SD 6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference of 6.2 percentage points [95% CI 4.4 to 8.0]; P < 0.0001). All prespecified CGM metrics favored closed loop over the sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (95% CI 0.3 to 1.1; P = 0.0005) and overnight by 0.8 percentage points (0.4 to 1.1; P < 0.0001) compared with sensor-augmented pump. There was no significant difference in HbA_1c between closed-loop versus sensor-augmented pump stages (7.3% [IQR, 7.1–7.5] (56 mmol/mol [54–59]) vs. 7.5% [7.1–7.9] (59 mmol/mol [54–62]), respectively; P = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage.

Closed-loop therapy is an effective treatment option for older adults with long-duration type 1 diabetes, and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed loop than during sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight.

评估闭环胰岛素输送与传感器增强泵治疗在老年 1 型糖尿病患者中的疗效和安全性。

这项开放标签、随机 (1:1) 交叉试验比较了 4 个月的闭环与传感器增强泵治疗。符合条件的成人年龄≥60 岁，患有 1 型糖尿病（病程≥10 年），使用胰岛素泵。主要结果是连续血糖监测 (CGM) 时间范围内 (TIR; 3.9–10.0 mmol/L)。

有 30 名参与者（平均年龄 67 [SD 5] 岁），中位 1 型糖尿病病程为 38 年（四分位距 [IQR] 20-47），随机（每个序列n = 15）；都完成了审判。闭环阶段的平均 TIR 为 75.2% (SD 6.3)，传感器增强泵阶段的平均 TIR 为 69.0% (9.1)（差异为 6.2 个百分点 [95% CI 4.4 至 8.0]；P < 0.0001）。所有预先指定的 CGM 指标都倾向于闭环，而不是传感器增强泵；一夜之间受益最大。闭环将 24 小时/天期间的 CGM 时间 <3.9 mmol/L 减少 0.5 个百分点（95% CI 0.3 至 1.1；P = 0.0005），过夜减少 0.8 个百分点（0.4 至 1.1；P< 0.0001) 与传感器增强泵相比。闭环与传感器增强泵级之间的 HbA _1c没有显着差异（7.3% [IQR, 7.1–7.5] (56 mmol/mol [54–59]) vs. 7.5% [7.1–7.9] (59 mmol / mol [54-62]），分别; P = 0.13）。在闭环阶段发生了 3 起严重的低血糖事件，在传感器增强泵阶段发生了 2 起；没有低血糖事件需要住院治疗。在传感器增强泵阶段发生了一次糖尿病酮症酸中毒；闭环阶段未发生严重不良事件。

对于患有长期 1 型糖尿病的老年人来说，闭环治疗是一种有效的治疗选择，并且没有发现安全问题。与传感器增强泵治疗相比，这些老年人在闭环期间具有更高的 TIR，并且低于范围的时间更少。具有特别临床意义的闭环减少了过夜在低血糖范围内的时间。