Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monito… (NCT06962735) | Clinical Trial Compass
CompletedNot Applicable
Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)
Canada220 participantsStarted 2024-01-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Change in HbA1c at 6-12-month follow-up compared to baseline
Timeframe: from index date to 6- to-12-month follow-up