Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Percent Time in Range (TIR)
研究概览
简要总结
The goal of this prospective study is to evaluate diabetes outcomes and patient experience following a switch from second generation intermittently scanned continuous glucose monitor (isCGM) to real-time continuous glucose monitor (rtCGM) compared with participants with continued isCGM use among adults with insulin-treated type 2 diabetes (T2D) in a specialist endocrinology clinic setting in Canada. The study aims include:
Primary outcome - Evaluate change in percent time in range (TIR) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with participants with continued second generation isCGM use.
Secondary outcomes - Compare glycemic and metabolic outcomes (ie. additional CGM metrics, HbA1c, and weight), and outcomes related to diabetes management (ie. self-reported hypoglycemia and change in total daily dose [TDD] of insulin) at 3-6 months follow-up in the rtCGM switch and isCGM cohorts among adults with insulin-treated T2D.
Exploratory outcomes - Evaluate patient-reported outcomes (PROs) in the rtCGM switch cohort only. PROs will include questions about device satisfaction and psychological distress at baseline and 3-6 months follow-up, and protocol-specific questions about Dexcom Care following use of the rtCGM device at 3-6 months follow-up. Additionally this study will compare percent TIR, percent TBR, percent TAR, and HbA1c between rtCGM switch and isCGM cohorts by insulin therapy subgroup (basal vs MDI therapy).
rtCGM switch participants will be enrolled at an LMC location and asked to complete PROs at baseline and 3-6 month follow-up. Continued isCGM participants will not be asked to complete PROs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Clinical diagnosis of T2D ≥ one year
- •Using insulin for ≥ 6 months
- •Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
- •Would like to switch from a FreeStyle Libre® 2 isCGM device to a Dexcom® G7 rtCGM device (rtCGM switch cohort) as of the study start date
- •Baseline HbA1c ≥ 7.5%
- •Known rtCGM/isCGM start date (month and year)
- •Exclusive use of isCGM for ≥ 3 months
- •Data on LibreView platforms have percent sensor capture ≥ 70% for 14 days of available data up to 6 months prior to index date
- •≥ 1 value for TIR (%) up to 6 months (± 6 weeks) prior to index date
- •≥ 1 value for HbA1c (%) up to 6 months (± 6 weeks) prior to index date
- •Data consent
排除标准
- •Have a prior history of rtCGM within 12 months of the index date
- •Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
- •Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
- •Are pregnant at the time of study enrollment or intending to become pregnant during the study
- •Used the isCGM or rtCGM for < 3 months
- •Using continuous subcutaneous insulin infusion
结局指标
主要结局
Change in Percent Time in Range (TIR)
时间窗: from enrollment to 6 months follow up
evaluate change in percent TIR (3.9 to 10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D. Percent TIR will be reported from the patient's EMR or Clarity® and LibreView® platforms (last 14 days of available data closest to the index date or 6-month follow-up date, where percent sensor capture is ≥ 70%).
次要结局
- Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%)(from enrollment to 6 months follow up)
- Percent Sensor Capture and Change in Percent Capture(from enrollment to 6 months follow up)
- Change in Percent Time Below Range (TBR)(from enrollment to 6 months follow up)
- Change in Mean Glucose(from enrollment to 6 months follow up)
- Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)(from enrollment to 6 months follow up)
- Change in Weight(from enrollment to 6 months follow up)
- Change in Proportion of Participants with ≥1 Self-reported Hypoglycemic Events per Week(from enrollment to 6 months follow up)
- Change in Total Daily Dose (TDD) of Insulin(from enrollment to 6 months follow up)
- Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia(from enrollment to 6 months follow up)
- Change in Percent Time Above Target Glucose Range (TAR)(from enrollment to 6 months follow up)
- Change in Frequency of Hypoglycemia Episodes(from enrollment to 6 months follow up)
- Change in HbA1c(from enrollment to 6 months follow up)
- Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up(from enrollment to 6 months follow up)
- Change in Weekly Incidence of Self-Reported Hypoglycemia(from enrollment to 6 months follow up)
- Change in Number of Non-Insulin Antihyperglycemic Agents (AHA)(from enrollment to 6 months follow up)
- Number of rtCGM Discontinuations(from enrollment to 6 months follow up)