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

NCT06805786 | Recruiting

• 1 other identifier: Switch CGM T2D
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; continuous glucose monitoring; HbA1c; time in range

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in Percent Time Below Range (TBR)

  from enrollment to 6 months follow up

• Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia

  from enrollment to 6 months follow up

• Change in Percent Time Above Target Glucose Range (TAR)

  from enrollment to 6 months follow up

• Change in Mean Glucose

  from enrollment to 6 months follow up

• Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)

  from enrollment to 6 months follow up

Other Outcomes (3)

• Glucose Monitoring Device Satisfaction Scale (GMSS)

  from enrollment to 6 months follow up

• Diabetes Distress Scale (DDS)

  from enrollment to 6 months follow up

• Protocol-Specific Dexcom Care Survey

  assessed at 3-6 month follow-up

Study Arms (2)

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

intermittently scanned continuous glucose monitoring group (isCGM group)

adults with insulin-treated T2D that are remaining on an isCGM for the whole study

Interventions

real-time continuous glucose monitor DEVICE

Individuals who switched from using isCGM to rtCGM

Real-time continuous glucose monitoring switch group (rtCGM switch group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• DexCom, Inc.: collaborator

Study Sites (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 3, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)