Status:
COMPLETED
Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)
Lead Sponsor:
LMC Diabetes & Endocrinology Ltd.
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
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 intermitten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06962735
Start Date
January 25 2024
End Date
August 29 2024
Last Update
May 11 2025
Active Locations (1)
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1
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, Canada, M4G3E8