Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
LMC Diabetes & Endocrinology Ltd.
RECRUITING
Toronto
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2026-07
Participants
Target number of participants: 150
Treatments
Real-time continuous glucose monitoring switch group (rtCGM switch group)
adults with insulin-treated T2D that are switching from an isCGM to an rtCGM
intermittently scanned continuous glucose monitoring group (isCGM group)
adults with insulin-treated T2D that are remaining on an isCGM for the whole study
Related Therapeutic Areas
Sponsors
Leads: LMC Diabetes & Endocrinology Ltd.
Collaborators: DexCom, Inc.

This content was sourced from clinicaltrials.gov

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