Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
Recruiting · NCT06805786 · Observational (researchers observe without assigning treatment) · Lead sponsor: LMC Diabetes & Endocrinology Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- LMC Diabetes & Endocrinology Ltd. - Toronto, Ontario, Canada