Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)

NCT ID: NCT06805786

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2026-07-31

Brief Summary

The goal of this prospective study is to evaluate diabetes outcomes and patient experience following a switch from second generation intermittently scanned continuous glucose monitor (isCGM) to real-time continuous glucose monitor (rtCGM) compared with participants with continued isCGM use among adults with insulin-treated type 2 diabetes (T2D) in a specialist endocrinology clinic setting in Canada. The study aims include:

Primary outcome - Evaluate change in percent time in range (TIR) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with participants with continued second generation isCGM use.

Secondary outcomes - Compare glycemic and metabolic outcomes (ie. additional CGM metrics, HbA1c, and weight), and outcomes related to diabetes management (ie. self-reported hypoglycemia and change in total daily dose [TDD] of insulin) at 3-6 months follow-up in the rtCGM switch and isCGM cohorts among adults with insulin-treated T2D.

Exploratory outcomes - Evaluate patient-reported outcomes (PROs) in the rtCGM switch cohort only. PROs will include questions about device satisfaction and psychological distress at baseline and 3-6 months follow-up, and protocol-specific questions about Dexcom Care following use of the rtCGM device at 3-6 months follow-up. Additionally this study will compare percent TIR, percent TBR, percent TAR, and HbA1c between rtCGM switch and isCGM cohorts by insulin therapy subgroup (basal vs MDI therapy).

rtCGM switch participants will be enrolled at an LMC location and asked to complete PROs at baseline and 3-6 month follow-up. Continued isCGM participants will not be asked to complete PROs.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

adults with insulin-treated T2D that are switching from an isCGM to an rtCGM

real-time continuous glucose monitor

Intervention Type: DEVICE

Individuals who switched from using isCGM to rtCGM

intermittently scanned continuous glucose monitoring group (isCGM group)

adults with insulin-treated T2D that are remaining on an isCGM for the whole study

No interventions assigned to this group

Interventions

real-time continuous glucose monitor

Individuals who switched from using isCGM to rtCGM

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Clinical diagnosis of T2D ≥ one year
• Using insulin for ≥ 6 months
• Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
• Would like to switch from a FreeStyle Libre® 2 isCGM device to a Dexcom® G7 rtCGM device (rtCGM switch cohort) as of the study start date
• Baseline HbA1c ≥ 7.5%
• Known rtCGM/isCGM start date (month and year)
• Exclusive use of isCGM for ≥ 3 months
• Data on LibreView platforms have percent sensor capture ≥ 70% for 14 days of available data up to 6 months prior to index date
• ≥ 1 value for TIR (%) up to 6 months (± 6 weeks) prior to index date
• ≥ 1 value for HbA1c (%) up to 6 months (± 6 weeks) prior to index date
• Data consent

Exclusion Criteria

• Have a prior history of rtCGM within 12 months of the index date
• Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
• Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
• Are pregnant at the time of study enrollment or intending to become pregnant during the study
• Used the isCGM or rtCGM for < 3 months
• Using continuous subcutaneous insulin infusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

LMC Diabetes & Endocrinology Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Manager, Data Science, LMC Healthcare

Role: primary

lisa.chu@lmc.ca

4166452929

Research Assistant, Data Science, LMC Healthcare

Role: backup

giovana.romero@lmc.ca

Other Identifiers

Switch CGM T2D

Identifier Type: -

Identifier Source: org_study_id