International Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.
Diabetes & Endocrine Treatment Specialists, Sandy, UT, USA.
J Diabetes Sci Technol. 2024 Nov;18(6):1288-1292. doi: 10.1177/19322968241234072. Epub 2024 Mar 5.
Control-IQ technology version 1.5 allows for a wider range of weight and total daily insulin (TDI) entry, in addition to other changes to enhance performance for users with high basal rates. This study evaluated the safety and performance of the updated Control-IQ system for users with basal rates >3 units/h and high TDI in a multicenter, single arm, prospective study.
Adults with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) and at least one basal rate over 3 units/h (N = 34, mean age = 39.9 years, 41.2% female, diabetes duration = 21.8 years) used the t:slim X2 insulin pump with Control-IQ technology version 1.5 for 13 weeks. Primary outcome was safety events (severe hypoglycemia and diabetic ketoacidosis (DKA)). Central laboratory hemoglobin A (HbA) was measured at system initiation and 13 weeks. Participants continued using glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT-2) inhibitors, or other medications for glycemic control and/or weight loss if on a stable dose.
All 34 participants completed the study. Fifteen participants used a basal rate >3 units/h for all 24 hours of the day. Nine participants used >300 units TDI on at least one day during the study. There were no severe hypoglycemia or DKA events. Time in range 70-180 mg/dL was 64.8% over the 13 weeks, with 1.0% time <70 mg/dL. Hemoglobin A decreased from 7.69% at baseline to 6.87% at 13 weeks (-0.82%, < .001).
Control-IQ technology version 1.5, with wider range of weight and TDI input and enhancements for users with high insulin requirements, was safe in individuals with T1D in this study.
Control-IQ 技术版本 1.5 允许更广泛的体重和总日胰岛素（TDI）输入范围，以及其他一些增强功能，以提高高基础率用户的性能。这项研究评估了更新后的 Control-IQ 系统在高基础率（>3 单位/小时）和高 TDI 的多中心、单臂、前瞻性研究中的安全性和性能。
使用持续皮下胰岛素输注（CSII）的 1 型糖尿病（T1D）成人（N=34，平均年龄 39.9 岁，41.2%为女性，糖尿病病程 21.8 年），使用 t:slim X2 胰岛素泵和 Control-IQ 技术版本 1.5，持续 13 周。主要结局是安全事件（严重低血糖和糖尿病酮症酸中毒（DKA））。系统启动时和 13 周时测量中心实验室血红蛋白 A（HbA）。如果参与者正在使用胰高血糖素样肽-1（GLP-1）受体激动剂、钠-葡萄糖转运蛋白 2（SGLT-2）抑制剂或其他药物进行血糖控制和/或体重减轻，则继续使用这些药物，且剂量稳定。
所有 34 名参与者均完成了研究。15 名参与者全天的基础率均>3 单位/小时。9 名参与者在研究期间至少有一天使用了>300 单位的 TDI。无严重低血糖或 DKA 事件。13 周内，血糖在 70-180mg/dL 之间的时间为 64.8%，血糖<70mg/dL 的时间为 1.0%。HbA 从基线时的 7.69%下降到 13 周时的 6.87%（-0.82%，<.001）。
在这项研究中，对于 T1D 患者，Control-IQ 技术版本 1.5 允许更广泛的体重和 TDI 输入范围，以及针对高胰岛素需求用户的增强功能，是安全的。
