NCT06805786Recruiting
Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 4 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 11 Feb 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06805786
What you commit to
- Study type: Observational
- Planned participants: 150
- From 11 Feb 2025 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LMC Diabetes & Endocrinology Ltd. Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.