Clinical trial NCT06962735: Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2025-05-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes adults, who were active patients with type 1 diabetes or type 2 diabetes at LMC, who switched from intermittently scanned continuous glucose monitoring to real-time continuous glucose monitoring (rtCGM switch cohort) or initiated and maintained intermittently scanned continuous glucose monitoring use (isCGM cohort).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c at 6-12-month follow-up compared to baseline
timeFrame: from index date to 6- to-12-month follow-up
Secondary outcomes:
measure: Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in percent time in target glucose range (TIR) at 6-12 months follow-up
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in percent time below target glucose range (TBR)
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in percent time above target glucose range (TAR)
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in mean glucose
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in standard deviation (SD) of mean glucose
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in coefficient of variation (CV) of mean glucose
timeFrame: from index date to 6- to-12-month follow-up
measure: Change in weight
timeFrame: from index date to 6- to-12-month follow-up
measure: Proportion of patients who achieve HbA1c ≤7.0%
timeFrame: evaluated at 6- to-12-month follow-up
measure: Weekly incidence of self-reported hypoglycemia
timeFrame: evaluated at 6- to-12-month follow-up
measure: Proportion of patients with ≥ 1 self-reported hypoglycemic event
timeFrame: evaluated at 6- to-12-month follow-up
measure: Change in total daily dose (TDD) of insulin
timeFrame: from index date to 6- to-12-month follow-up
measure: Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort
timeFrame: from index date to 6- to-12-month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Endocrinology Ltd.
state: Ontario
Study officials:
References: