Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D) (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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: real-time continuous glucose monitor

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3E8
      • Recruiting
      • LMC Diabetes & Endocrinology Ltd.
      • Contact: Manager, Data Science, LMC Healthcare; Phone Number: 4166452929; Email: lisa.chu@lmc.ca
      • Contact: Research Assistant, Data Science, LMC Healthcare; Email: giovana.romero@lmc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Real-time continuous glucose monitoring switch group (rtCGM switch group); adults with insulin-treated T2D that are switching from an isCGM to an rtCGM	Device: real-time continuous glucose monitor; Individuals who switched from using isCGM to rtCGM
intermittently scanned continuous glucose monitoring group (isCGM group); adults with insulin-treated T2D that are remaining on an isCGM for the whole study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percent Time in Range (TIR)	evaluate change in percent TIR (3.9 to 10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D. Percent TIR will be reported from the patient's EMR or Clarity® and LibreView® platforms (last 14 days of available data closest to the index date or 6-month follow-up date, where percent sensor capture is ≥ 70%).	from enrollment to 6 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percent Time Below Range (TBR)	Evaluate change in percent TBR (<3.9 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia	Evaluate change in percent TBR in level 2 hypoglycemia (<3.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Percent Time Above Target Glucose Range (TAR)	Evaluate change in percent TAR (>10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Mean Glucose	Evaluate change in mean glucose (mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)	Evaluate change in glycemic variability reported as standard deviation (SD) (mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%)	Evaluate change in glycemic variability reported as CV (%) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Frequency of Hypoglycemia Episodes	Evaluate change in frequency of hypoglycemia episodes (frequency of events <3.9 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Percent Sensor Capture and Change in Percent Capture	Evaluate Percent sensor capture and evaluate the change in percent sensor capture at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in HbA1c	Evaluate change in HbA1c (%) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up	Evaluate portion of participants achieving HbA1c ≤ 7.0% at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Weight	Evaluate change in weight (kg) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Weekly Incidence of Self-Reported Hypoglycemia	Evaluate change in weekly incidence of self-reported hypoglycemia at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Proportion of Participants with ≥1 Self-reported Hypoglycemic Events per Week	Evaluate change in proportion of participants with ≥1 self-reported hypoglycemic events per week at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Number of Non-Insulin Antihyperglycemic Agents (AHA)	Evaluate change in number of non-insulin AHAs at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Change in Total Daily Dose (TDD) of Insulin	Evaluate change in total daily dose of insulin at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.	from enrollment to 6 months follow up
Number of rtCGM Discontinuations	Evaluate the number of rtCGM discontinuations at 3-6 months follow-up only for the cohort switching from a second generation isCGM system to a rtCGM system.	from enrollment to 6 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Monitoring Device Satisfaction Scale (GMSS)	includes questions about device satisfaction, filled out only by the cohort switching from isCGM to rtCGM	from enrollment to 6 months follow up
Diabetes Distress Scale (DDS)	includes questions about psychological distress , filled out only by the cohort switching from isCGM to rtCGM	from enrollment to 6 months follow up
Protocol-Specific Dexcom Care Survey	includes protocol-specific questions about rtCGM device, filled out only by the cohort switching from isCGM to rtCGM	assessed at 3-6 month follow-up

Collaborators and Investigators

• Sponsor: LMC Diabetes & Endocrinology Ltd.
• Collaborators: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HbA1c; type 2 diabetes; continuous glucose monitoring; time in range
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: Switch CGM T2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a real-world study using data retrieved from a national Diabetes Registry. IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No