Actively Recruiting
Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
Led by LMC Diabetes & Endocrinology Ltd. · Updated on 2025-05-04
150
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
Sponsors
L
LMC Diabetes & Endocrinology Ltd.
Lead Sponsor
D
DexCom, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Clinical diagnosis of type 2 diabetes for at least one year
- Using insulin for at least 6 months
- Continued use of FreeStyle Libre�ae 2 isCGM device at study start
- Interested in switching to Dexcom�ae G7 rtCGM device at study start
- Baseline HbA1c of 7.5% or higher
- Known rtCGM or isCGM start date (month and year)
- Exclusive use of isCGM for at least 3 months
- Sensor data capture of 70% or more for 14 days within 6 months prior to index date
- At least one value for percent time in range (TIR) within 6 months prior to index date
- At least one HbA1c value within 6 months prior to index date
- Provided data consent
You will not qualify if you...
- Prior use of rtCGM within 12 months before index date
- Recent or expected changes to antihyperglycemic medications or doses within 30 days of index date
- Recent or expected insulin dose changes of 20% or more within 30 days of index date
- Pregnant at enrollment or planning pregnancy during the study
- Used isCGM or rtCGM for less than 3 months
- Using continuous subcutaneous insulin infusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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