Clinical trial NCT06805786: Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
continuous glucose monitoring
HbA1c
time in range
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2025-02-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be adults, who are active patients with insulin-treated T2D at LMC, who switch from a FreeStyle Libre® 2 device to a Dexcom® G7 (rtCGM switch cohort) or initiated a FreeStyle Libre® 2 and maintain isCGM use (isCGM cohort) after December 2024

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.


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

Primary outcomes:
measure: Change in Percent Time in Range (TIR)
timeFrame: from enrollment to 6 months follow up
Secondary outcomes:
measure: Change in Percent Time Below Range (TBR)
timeFrame: from enrollment to 6 months follow up
measure: Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia
timeFrame: from enrollment to 6 months follow up
measure: Change in Percent Time Above Target Glucose Range (TAR)
timeFrame: from enrollment to 6 months follow up
measure: Change in Mean Glucose
timeFrame: from enrollment to 6 months follow up
measure: Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)
timeFrame: from enrollment to 6 months follow up
measure: Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%)
timeFrame: from enrollment to 6 months follow up
measure: Change in Frequency of Hypoglycemia Episodes
timeFrame: from enrollment to 6 months follow up
measure: Percent Sensor Capture and Change in Percent Capture
timeFrame: from enrollment to 6 months follow up
measure: Change in HbA1c
timeFrame: from enrollment to 6 months follow up
measure: Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up
timeFrame: from enrollment to 6 months follow up
measure: Change in Weight
timeFrame: from enrollment to 6 months follow up
measure: Change in Weekly Incidence of Self-Reported Hypoglycemia
timeFrame: from enrollment to 6 months follow up
measure: Change in Proportion of Participants with ≥1 Self-reported Hypoglycemic Events per Week
timeFrame: from enrollment to 6 months follow up
measure: Change in Number of Non-Insulin Antihyperglycemic Agents (AHA)
timeFrame: from enrollment to 6 months follow up
measure: Change in Total Daily Dose (TDD) of Insulin
timeFrame: from enrollment to 6 months follow up
measure: Number of rtCGM Discontinuations
timeFrame: from enrollment to 6 months follow up
Other outcomes:
measure: Glucose Monitoring Device Satisfaction Scale (GMSS)
timeFrame: from enrollment to 6 months follow up
measure: Diabetes Distress Scale (DDS)
timeFrame: from enrollment to 6 months follow up
measure: Protocol-Specific Dexcom Care Survey
timeFrame: assessed at 3-6 month follow-up
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Endocrinology Ltd.
state: Ontario
Study officials:
References: