Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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 A1c (HbA1c) 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.
UNASSIGNED: 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 A1c decreased from 7.69% at baseline to 6.87% at 13 weeks (-0.82%, P < .001).
UNASSIGNED: 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.
UNASSIGNED: 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 A1c (HbA1c) 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.
UNASSIGNED: 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 A1c decreased from 7.69% at baseline to 6.87% at 13 weeks (-0.82%, P < .001).
UNASSIGNED: 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.
摘要：
■Control-IQ技术版本1.5允许更广泛的体重和每日总胰岛素（TDI）输入，此外，还进行了其他更改，以增强具有高基础费率的用户的性能。本研究评估了更新的Control-IQ系统的安全性和性能，适用于多中心基础费率>3单位/小时和高TDI的用户，单臂,前瞻性研究。
■使用连续皮下胰岛素输注（CSII）并在3个单位/小时内至少进行一次基础率的1型糖尿病（T1D）成人（N=34，平均年龄=39.9岁，41.2%女性，糖尿病持续时间=21.8年）使用t：slimX2胰岛素泵和Control-IQ技术1.5版，持续13周。主要结局是安全性事件（严重低血糖和糖尿病酮症酸中毒（DKA））。在系统启动和13周时测量中心实验室血红蛋白A1c（HbA1c）。参与者继续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，或其他用于血糖控制和/或体重减轻的药物，如果在稳定剂量。
■所有34名参与者完成了研究。15名参与者在一天的所有24小时内使用>3单位/小时的基础率。9名参与者在研究期间至少一天使用了>300单位TDI。无严重低血糖或DKA事件发生。在13周内，70-180毫克/分升的时间为64.8%，1.0%时间<70mg/dL。血红蛋白A1c从基线时的7.69%下降到13周时的6.87%(-0.82%,P<.001)。
■Control-IQ技术版本1.5，具有更广泛的重量和TDI输入范围，并为胰岛素要求高的用户提供增强功能，在这项研究中，T1D患者是安全的。
■使用连续皮下胰岛素输注（CSII）并在3个单位/小时内至少进行一次基础率的1型糖尿病（T1D）成人（N=34，平均年龄=39.9岁，41.2%女性，糖尿病持续时间=21.8年）使用t：slimX2胰岛素泵和Control-IQ技术1.5版，持续13周。主要结局是安全性事件（严重低血糖和糖尿病酮症酸中毒（DKA））。在系统启动和13周时测量中心实验室血红蛋白A1c（HbA1c）。参与者继续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，或其他用于血糖控制和/或体重减轻的药物，如果在稳定剂量。
■所有34名参与者完成了研究。15名参与者在一天的所有24小时内使用>3单位/小时的基础率。9名参与者在研究期间至少一天使用了>300单位TDI。无严重低血糖或DKA事件发生。在13周内，70-180毫克/分升的时间为64.8%，1.0%时间<70mg/dL。血红蛋白A1c从基线时的7.69%下降到13周时的6.87%(-0.82%,P<.001)。
■Control-IQ技术版本1.5，具有更广泛的重量和TDI输入范围，并为胰岛素要求高的用户提供增强功能，在这项研究中，T1D患者是安全的。
