在胰岛素需求量高的人群中使用 Control-IQ 技术:多中心更高智商试验的结果。

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Journal of Diabetes Science and Technology Pub Date : 2024-11-01 Epub Date: 2024-03-05 DOI:10.1177/19322968241234072
Anders L Carlson, Timothy E Graham, Halis K Akturk, David R Liljenquist, Richard M Bergenstal, Becky Sulik, Viral N Shah, Mark Sulik, Peter Zhao, Peter Briggs, Ravid Sassan-Katchalski, Jordan E Pinsker
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引用次数: 0

摘要

背景介绍1.5版Control-IQ技术允许在更大范围内输入体重和每日胰岛素总量(TDI),此外还进行了其他改动,以提高高基础率用户的性能。本研究在一项多中心、单臂、前瞻性研究中评估了更新版 Control-IQ 系统对基础率大于 3 单位/小时和高 TDI 用户的安全性和性能:使用连续皮下胰岛素输注(CSII)且至少有一次基础率超过 3 单位/小时的 1 型糖尿病(T1D)成人(34 人,平均年龄 39.9 岁,女性占 41.2%,糖尿病病程 21.8 年)使用带有 Control-IQ 技术 1.5 版的 t:slim X2 胰岛素泵 13 周。主要结果是安全事件(严重低血糖和糖尿病酮症酸中毒(DKA))。中心实验室在系统启动和 13 周时测量血红蛋白 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)抑制剂或其他药物控制血糖和/或减轻体重(如果剂量稳定):所有 34 名参与者都完成了研究。15 名参与者一天 24 小时的基础血糖率均大于 3 单位/小时。九名参与者在研究期间至少有一天使用了大于 300 单位的 TDI。没有发生严重低血糖或 DKA 事件。13 周内,血糖在 70-180 mg/dL 范围内的时间为 64.8%,1.0% 的时间 1c 从基线时的 7.69% 降至 13 周时的 6.87% (-0.82%, P < .001):在这项研究中,Control-IQ 技术 1.5 版的体重和 TDI 输入范围更广,并针对胰岛素需求量大的用户进行了改进,对 T1D 患者是安全的。
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Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial.

Background: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
期刊最新文献
Continuous Glucose Monitoring-Derived Glycemic Phenotyping of Childhood Hypoglycemia due to Hyperinsulinism: A Year-long Prospective Nationwide Observational Study. Diabetes Technology Use in Special Populations: A Narrative Review of Psychosocial Factors. Addressing Inequity in Continuous Glucose Monitoring Access: Leveraging the Hospital in the Continuum of Care. What is the Relationship Between Time in Range, Time in Tight Range, and HbA1c in Youth and Young Adults With Type 1 Diabetes? Results From the German/Austrian/Luxembourgian/Swiss Diabetes Prospective Follow-Up Registry. The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring.
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