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

NCT06962735 | Completed

• 1 other identifier: Switch CGM retro
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c at 6-12-month follow-up compared to baseline

  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

  from index date to 6- to-12-month follow-up

Secondary Outcomes (13)

• Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort

  from index date to 6- to-12-month follow-up

• 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

• Change in percent time below target glucose range (TBR)

  from index date to 6- to-12-month follow-up

• Change in percent time above target glucose range (TAR)

  from index date to 6- to-12-month follow-up

• Change in mean glucose

  from index date to 6- to-12-month follow-up

Study Arms (2)

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

adults with diabetes that switched from an isCGM to an rtCGM

Device: real-time continuous glucose monitor

intermittently scanned continuous glucose monitoring group (isCGM group)

adults with diabetes that remained on an isCGM

Interventions

real-time continuous glucose monitor DEVICE

Individuals who switched from using isCGM to rtCGM

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• DexCom, Inc.: collaborator

Study Sites (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: January 25, 2024
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)