Kudva Yogish C, Henderson Robert J, Kanapka Lauren G, Weinstock Ruth S, Rickels Michael R, Pratley Richard E, Chaytor Naomi, Janess Kamille, Desjardins Donna, Pattan Vishwanath, Peleckis Amy J, Casu Anna, Rizvi Shafaq Raza, Bzdick Suzan, Whitaker Keri J, Jo Kamimoto Jorge L, Miller Kellee, Kollman Craig, Beck Roy W
Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Jaeb Center for Health Research, Tampa, FL.
NEJM Evid. 2025 Jan;4(1):EVIDoa2400200. doi: 10.1056/EVIDoa2400200. Epub 2024 Dec 23.
Older adults with type 1 diabetes are at risk for serious hypoglycemia. Automated insulin delivery can reduce risk but has not been sufficiently evaluated in this population.
We conducted a multicenter, randomized crossover trial in adults older than or equal to 65 years of age with type 1 diabetes. Participants completed three 12-week periods of using hybrid closed loop, predictive low-glucose suspend, and sensor-augmented pump insulin delivery in a randomized order. The primary outcome was the percentage of time with continuous glucose monitoring glucose values less than 70 mg/dl.
Eighty-two participants between 65 and 86 years of age were randomly assigned: 45% were female; the baseline mean (±SD) glycated hemoglobin level was 7.2±0.9%; and the baseline percentage of time with glucose values less than 70 mg/dl was 2.49±1.78%. In the sensor-augmented pump, hybrid closed-loop, and predictive low-glucose suspend periods, percentages of time with glucose less than 70 mg/dl were 2.57±1.54%, 1.58±0.95%, and 1.67±0.96%, respectively. Compared with the sensor-augmented pump results, the mean difference with the hybrid closed-loop system was -1.05 percentage points (95% confidence interval [CI], -1.48 to -0.73 percentage points; P<0.001) and with the predictive low-glucose suspend system it was -0.93 percentage points (95% CI, -1.27 to -0.66 percentage points; P<0.001). Comparing a hybrid closed-loop system with a sensor-augmented pump, time in the range 70 to 180 mg/dl changed by 8.9 percentage points (95% CI, 7.4 to 10.4 percentage points) and the glycated hemoglobin level changed by 0.2 percentage points (95% CI, -0.3 to -0.1 percentage points). Serious adverse events were uncommon. Severe hypoglycemia occurred in 4% or less of participants; there were two hospitalizations for diabetic ketoacidosis.
In older adults with type 1 diabetes, automated insulin delivery decreased hypoglycemia compared with sensor-augmented pump delivery. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number: NCT04016662.).
1型糖尿病老年患者有发生严重低血糖的风险。自动胰岛素输注可降低风险，但在该人群中尚未得到充分评估。
我们对年龄≥65岁的1型糖尿病成人患者进行了一项多中心随机交叉试验。参与者以随机顺序完成三个为期12周的阶段，分别使用混合闭环、预测性低血糖暂停和传感器增强型泵胰岛素输注。主要结局是持续葡萄糖监测血糖值低于70mg/dl的时间百分比。
82名年龄在65至86岁之间的参与者被随机分配：45%为女性；糖化血红蛋白水平的基线均值（±标准差）为7.2±0.9%；血糖值低于70mg/dl的基线时间百分比为2.49±1.78%。在传感器增强型泵、混合闭环和预测性低血糖暂停阶段，血糖低于70mg/dl的时间百分比分别为2.57±1.54%、1.58±0.95%和1.67±0.96%。与传感器增强型泵的结果相比，混合闭环系统的平均差异为-1.05个百分点（95%置信区间[CI]，-1.48至-0.73个百分点；P<0.001），预测性低血糖暂停系统的平均差异为-0.93个百分点（95%CI，-1.27至-0.66个百分点；P<0.001）。将混合闭环系统与传感器增强型泵进行比较，70至180mg/dl范围内的时间变化了8.9个百分点（95%CI，7.4至10.4个百分点），糖化血红蛋白水平变化了0.2个百分点（95%CI，-0.3至-0.1个百分点）。严重不良事件并不常见。4%或更少的参与者发生了严重低血糖；有2例因糖尿病酮症酸中毒住院。
在1型糖尿病老年患者中，与传感器增强型泵输注相比，自动胰岛素输注降低了低血糖的发生。（由美国国立糖尿病、消化和肾脏疾病研究所等资助；ClinicalTrials.gov编号：NCT04016662。）
