One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology.

One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology.
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Control-IQ高级混合闭环技术的一年实际使用。

DOI:
10.1089/dia.2021.0097
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发表时间:
2021-09
影响因子:
5.4
通讯作者:
Kovatchev BP
Kovatchev BP
中科院分区:
医学3区
文献类型:
--
作者:
Breton MD;Kovatchev BP

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背景:Tandem糖尿病护理公司的T:SILM X2™胰岛素泵采用Control-IQ®技术,是一种先进的混合闭环系统,于2020年1月在美国首次商业化。与实际使用该系统相关的纵向血糖结果尚未报道。方法:回顾分析截至2021年2月11日,Control-IQ技术用户将数据上传到Tandem的t:Connect®网络应用程序的情况。用户年龄为6岁,在控制智商技术启动前2周和控制智商技术启动后12个月的连续血糖监测(≥)数据包括在分析中。结果:在9451名符合纳入标准的使用者中,83%患有1型糖尿病,其余的患有2型或其他形式的糖尿病。平均年龄42.6 ± 2 0.8岁,女性占5 2%。在整个12个月的观察期间,自动化时间的中位数为94.2%[四分位数范围,IQR:90.1%-96.4%],随着时间的推移没有显著变化。在这些用户中,9010人(96.8%)有75%的CGM数据可用,也就是说,有足够的数据来可靠地计算基于CGM的血糖结果。在基线时,控制智商技术使用12个月的中位百分比时间(70-180 mg/dL)是63.6%(智商:49.9%-75.6%),增加到73.6%(智商:64.4%-81.8%),随着时间的推移没有显著变化。时间和70 mg/dL的中位数百分比保持一致,∼为1%(IQR0.5%-1.9%)。结论:在这一现实世界的使用分析中,Control-IQ技术保留并在一定程度上超过了随机对照试验中获得的结果,显示出不同类型糖尿病患者的广泛年龄范围内的血糖改善。
Background: 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. Methods: 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. Results: 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%). Conclusion: 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.
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