Recruiting

Real-Time CGM

Sponsor:

LMC Diabetes & Endocrinology Ltd.

Code:

NCT06805786

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

real-time continuous glucose monitor

Study Details

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 ID

NCT06805786

Start date

Feb 11, 2025

Status verified date

Apr, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

intermittently scanned continuous glucose monitoring group (isCGM group)

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

Interventions

real-time continuous glucose monitor

Individuals who switched from using isCGM to rtCGM

Primary outcome measure

  • Change in Percent Time in Range (TIR) [ Time Frame: from enrollment to 6 months follow up ]

Central Contacts and Locations

Locations

LMC Diabetes & Endocrinology Ltd.

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Contacts

Manager, Data Science, LMC Healthcare

4166452929lisa.chu@lmc.ca

Research Assistant, Data Science, LMC Healthcare

giovana.romero@lmc.ca

More Information

Sponsor

LMC Diabetes & Endocrinology Ltd.

Last update posted

May 4, 2025

Last verified

Apr, 2025

Keywords

  • type 2 diabetes
  • continuous glucose monitoring
  • HbA1c
  • time in range

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LMC Diabetes & Endocrinology Ltd. on 2025-05-04.