Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: real-time continuous glucose monitor.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Type 2 Diabetes
Overview
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.
Interventions
- Device real-time continuous glucose monitor
Individuals who switched from using isCGM to rtCGM
Primary outcome measures
- Change in Percent Time in Range (TIR) [Time frame: from enrollment to 6 months follow up]
Secondary outcome measures (12)
- Change in Percent Time Below Range (TBR) [Time frame: from enrollment to 6 months follow up]
- Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia [Time frame: from enrollment to 6 months follow up]
- Change in Percent Time Above Target Glucose Range (TAR) [Time frame: from enrollment to 6 months follow up]
- Change in Mean Glucose [Time frame: from enrollment to 6 months follow up]
- Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L) [Time frame: from enrollment to 6 months follow up]
- Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%) [Time frame: from enrollment to 6 months follow up]
- Change in Frequency of Hypoglycemia Episodes [Time frame: from enrollment to 6 months follow up]
- Percent Sensor Capture and Change in Percent Capture [Time frame: from enrollment to 6 months follow up]
- Change in HbA1c [Time frame: from enrollment to 6 months follow up]
- Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up [Time frame: from enrollment to 6 months follow up]
- Change in Weight [Time frame: from enrollment to 6 months follow up]
- Change in Weekly Incidence of Self-Reported Hypoglycemia [Time frame: from enrollment to 6 months follow up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- LMC Diabetes & Endocrinology Ltd. — Toronto
Identifiers
NCT: NCT06805786 · Switch CGM T2D