Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)

LMC Diabetes & Endocrinology Ltd.

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: real-time continuous glucose monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06962735

Switch CGM retro

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

220 participants in 2 patient groups

real-time continuous glucose monitoring switch group (rtCGM switch group)

Description:

adults with diabetes that switched from an isCGM to an rtCGM

Treatment:

Device: real-time continuous glucose monitor

intermittently scanned continuous glucose monitoring group (isCGM group)

Description:

adults with diabetes that remained on an isCGM