Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT06962735
- Lead Sponsor
- LMC Diabetes & Endocrinology Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c at 6-12-month follow-up compared to baseline 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
- Secondary Outcome Measures
Name Time Method Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort from index date to 6- to-12-month follow-up To evaluate proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort during the study period from baseline to 6-12 months follow-up.
Change in total daily dose (TDD) of insulin from index date to 6- to-12-month follow-up To evaluate change in TDD of insulin at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort from index date to 6- to-12-month follow-up To compare 6-12 month change in HbA1c in the rtCGM switch cohort, who switched from isCGM to rtCGM, compared to a propensity score matched isCGM cohort, who maintained isCGM use, among a subgroup of patients with T1D and HbA1c ≥ 7.5%.
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 To evaluate change in percent TIR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in percent time below target glucose range (TBR) from index date to 6- to-12-month follow-up To evaluate change in percent TBR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in percent time above target glucose range (TAR) from index date to 6- to-12-month follow-up To evaluate change in percent TAR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in mean glucose from index date to 6- to-12-month follow-up To evaluate change in mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in standard deviation (SD) of mean glucose from index date to 6- to-12-month follow-up To evaluate change in SD of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in coefficient of variation (CV) of mean glucose from index date to 6- to-12-month follow-up To evaluate change in CV of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Change in weight from index date to 6- to-12-month follow-up To evaluate change in weight at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Proportion of patients who achieve HbA1c ≤7.0% evaluated at 6- to-12-month follow-up To evaluate the proportion of patients who achieve HbA1c ≤7.0% at 6-12 months follow-up in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% at baseline and propensity score matched isCGM cohort with HbA1c ≥ 7.5% at baseline.
Weekly incidence of self-reported hypoglycemia evaluated at 6- to-12-month follow-up To evaluate weekly incidence of self-reported hypoglycemia at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Proportion of patients with ≥ 1 self-reported hypoglycemic event evaluated at 6- to-12-month follow-up To evaluate proportion of patients with ≥ 1 self-reported hypoglycemic event at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.
Trial Locations
- Locations (1)
LMC Diabetes & Endocrinology Ltd.
🇨🇦Toronto, Ontario, Canada