NCT06962735已完成不适用
Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Diabetes: A Real-world, Canadian Retrospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in HbA1c at 6-12-month follow-up compared to baseline
研究概览
简要总结
The objective of this retrospective, observational study, is to better understand the real-world glycemic effectiveness of switching to real time continuous glucose monitoring (rtCGM) from intermittently scanned continuous glucose monitoring (isCGM) among adults with type 1 diabetes or type 2 diabetes in Canada.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older as of the index date
- •Clinical diagnosis of T1D or T2D ≥ one year
- •Using either MDI or CSII therapy
- •Initiated a FreeStyle Libre® isCGM device between January 1, 2018 and July 31, 2023 (isCGM cohort)
- •Switched from a FreeStyle Libre® 1 or Libre 2® isCGM device to a Dexcom® G5 or G6 CGM device between April 1, 2018 and July 31, 2023 (rtCGM cohort)
- •Baseline HbA1c ≥7.0% for primary objective with rtCGM cohort
- •Baseline HbA1c ≥8.0% for key secondary objective comparing rtCGM cohort to isCGM cohort
- •Known rtCGM/isCGM start date (month and year)
- •Exclusive use of isCGM for ≥ 3 months
- •≥ one HbA1c value up to 6 months (± 6 weeks) prior to index date (HbA1c value must be after isCGM initiation and no more than 6 weeks after the index date)
- •≥ one HbA1c value 6-12 months (± 6 weeks) following the index date
- •Informed consent for their medical record data to be used for research purposes
排除标准
- •Have a prior history of rtCGM within 12 months of the index date
- •Are pregnant at the time of isCGM initiation or time of switch to rtCGM
- •Used the isCGM or rtCGM for < 3 months
结局指标
主要结局
Change in HbA1c at 6-12-month follow-up compared to baseline
时间窗: from index date to 6- to-12-month follow-up
To evaluate change in HbA1c at 6-12-month follow-up compared to baseline after switching from an isCGM system to a rtCGM system in adults with type 1 diabetes
次要结局
- Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort(from index date to 6- to-12-month follow-up)
- Change in percent time in target glucose range (TIR) at 6-12 months follow-up(from index date to 6- to-12-month follow-up)
- Change in percent time below target glucose range (TBR)(from index date to 6- to-12-month follow-up)
- Change in percent time above target glucose range (TAR)(from index date to 6- to-12-month follow-up)
- Change in mean glucose(from index date to 6- to-12-month follow-up)
- Change in standard deviation (SD) of mean glucose(from index date to 6- to-12-month follow-up)
- Change in coefficient of variation (CV) of mean glucose(from index date to 6- to-12-month follow-up)
- Change in weight(from index date to 6- to-12-month follow-up)
- Proportion of patients who achieve HbA1c ≤7.0%(evaluated at 6- to-12-month follow-up)
- Weekly incidence of self-reported hypoglycemia(evaluated at 6- to-12-month follow-up)
- Proportion of patients with ≥ 1 self-reported hypoglycemic event(evaluated at 6- to-12-month follow-up)
- Change in total daily dose (TDD) of insulin(from index date to 6- to-12-month follow-up)
- Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort(from index date to 6- to-12-month follow-up)
研究者
研究点 (1)
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