Department of Endocrinology and Diabetology, Montpellier University Hospital, Montpellier, France.
Department of Physiology, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, France.
Diabetes Care. 2023 Dec 1;46(12):2180-2187. doi: 10.2337/dc23-0685.
Assess the safety and efficacy of automated insulin delivery (AID) in adults with type 1 diabetes (T1D) at high risk for hypoglycemia.
Participants were 72 adults with T1D who used an insulin pump with Clarke Hypoglycemia Perception Awareness scale score >3 and/or had severe hypoglycemia during the previous 6 months confirmed by time below range (TBR; defined as sensor glucose [SG] reading <70 mg/dL) of at least 5% during 2 weeks of blinded continuous glucose monitoring (CGM). Parallel-arm, randomized trial (2:1) of AID (Tandem t:slim ×2 with Control-IQ technology) versus CGM and pump therapy for 12 weeks. The primary outcome was TBR change from baseline. Secondary outcomes included time in target range (TIR; 70-180 mg/dL), time above range (TAR), mean SG reading, and time with glucose level <54 mg/dL. An optional 12-week extension with AID was offered to all participants.
Compared with the sensor and pump (S&P), AID resulted in significant reduction of TBR by -3.7% (95% CI -4.8, -2.6), P < 0.001; an 8.6% increase in TIR (95% CI 5.2, 12.1), P < 0.001; and a -5.3% decrease in TAR (95% CI -87.7, -1.8), P = 0.004. Mean SG reading remained similar in the AID and S&P groups. During the 12-week extension, the effects of AID were sustained in the AID group and reproduced in the S&P group. Two severe hypoglycemic episodes occurred using AID.
In adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than twofold, as quantified by TBR, while improving TIR and reducing hyperglycemia. Hence, AID is strongly recommended for this specific population.
评估在低血糖风险高的 1 型糖尿病（T1D）成人中使用自动胰岛素输送（AID）的安全性和疗效。
参与者为 72 名 T1D 成人，他们使用胰岛素泵， Clarke 低血糖感知意识量表评分 >3，或在前 6 个月内有严重低血糖史，在 2 周的盲法连续血糖监测（CGM）期间，传感器血糖 [SG] 读数<70mg/dL 的时间至少占 5%，定义为 TBR 低于范围（TBR）。平行臂、随机试验（2:1）的 AID（Tandem t:slim×2 与 Control-IQ 技术）与 CGM 和泵治疗 12 周。主要结局是从基线开始的 TBR 变化。次要结局包括目标范围内时间（TIR；70-180mg/dL）、TAR、平均 SG 读数和血糖水平<54mg/dL 的时间。所有参与者都提供了一个可选的 12 周的 AID 扩展。
与传感器和泵（S&P）相比，AID 可显著降低 TBR（-3.7%，95%CI-4.8，-2.6），P<0.001；TIR 增加 8.6%（95%CI 5.2，12.1），P<0.001；TAR 降低 5.3%（95%CI-87.7，-1.8），P=0.004。AID 和 S&P 组的平均 SG 读数相似。在 12 周的扩展期间，AID 组的效果持续，S&P 组的效果重现。使用 AID 发生了 2 例严重低血糖事件。
在低血糖风险高的 T1D 成人中，AID 可将 TBR 作为衡量标准，将低血糖风险降低两倍以上，同时提高 TIR 并降低高血糖。因此，强烈推荐将 AID 用于该特定人群。
