Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.
Diabetes Technol Ther. 2021 Sep;23(9):601-608. doi: 10.1089/dia.2021.0097. Epub 2021 Apr 21.
The t:slim X2™ insulin pump with Control-IQ technology from Tandem Diabetes Care is an advanced hybrid closed-loop system that was first commercialized in the United States in January 2020. Longitudinal glycemic outcomes associated with real-world use of this system have yet to be reported. A retrospective analysis of Control-IQ technology users who uploaded data to Tandem's t:connect web application as of February 11, 2021 was performed. Users age ≥6 years, with >2 weeks of continuous glucose monitoring (CGM) data pre- and >12 months post-Control-IQ technology initiation were included in the analysis. In total 9451 users met the inclusion criteria, 83% had type 1 diabetes, and the rest had type 2 or other forms of diabetes. The mean age was 42.6 ± 20.8 years, and 52% were female. Median percent time in automation was 94.2% [interquartile range, IQR: 90.1%-96.4%] for the entire 12-month duration of observation, with no significant changes over time. Of these users, 9010 (96.8%) had ≥75% of their CGM data available, that is, sufficient data for reliable computation of CGM-based glycemic outcomes. At baseline, median percent time in range (70-180 mg/dL) was 63.6 (IQR: 49.9%-75.6%) and increased to 73.6% (IQR: 64.4%-81.8%) for the 12 months of Control-IQ technology use with no significant changes over time. Median percent time <70 mg/dL remained consistent at ∼1% (IQR: 0.5%-1.9%). In this real-world use analysis, Control-IQ technology retained, and to some extent exceeded, the results obtained in randomized controlled trials, showing glycemic improvements in a broad age range of people with different types of diabetes.
由 Tandem Diabetes Care 生产的 t:slim X2™ 胰岛素泵与 Control-IQ 技术是一种先进的混合闭环系统,于 2020 年 1 月首次在美国商业化。该系统在实际应用中的长期血糖结果尚未报道。对截至 2021 年 2 月 11 日向 Tandem 的 t:connect 网络应用程序上传数据的 Control-IQ 技术用户进行了回顾性分析。该分析纳入了年龄≥6 岁、在启用 Control-IQ 技术前有>2 周的连续血糖监测(CGM)数据、且在启用后有>12 个月 CGM 数据的用户。共有 9451 名用户符合纳入标准,83%患有 1 型糖尿病,其余患者患有 2 型或其他类型的糖尿病。患者的平均年龄为 42.6±20.8 岁,52%为女性。在整个 12 个月的观察期间,自动化的中位百分比为 94.2%[四分位距(IQR):90.1%-96.4%],且随时间无显著变化。在这些患者中,9010 名(96.8%)患者的 CGM 数据有≥75%可用,即有足够的数据可用于可靠计算基于 CGM 的血糖结果。在基线时,范围内(70-180mg/dL)的中位时间百分比为 63.6%(IQR:49.9%-75.6%),在启用 Control-IQ 技术的 12 个月内增加到 73.6%(IQR:64.4%-81.8%),且随时间无显著变化。中位<70mg/dL 的时间百分比保持在约 1%(IQR:0.5%-1.9%)不变。在这项真实世界使用分析中,Control-IQ 技术保持了(并在某种程度上超过了)随机对照试验中的结果,表明该技术在不同类型糖尿病的广泛年龄范围内都能改善血糖。