RecruitingNCT06805786

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


Sponsor

LMC Diabetes & Endocrinology Ltd.

Enrollment

150 participants

Start Date

Feb 11, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of continuous glucose monitors (devices that track blood sugar levels) in adults with Type 2 diabetes who use insulin — specifically, one that you scan manually (FreeStyle Libre 2) versus one that reads continuously and sends automatic alerts (Dexcom G7). **You may be eligible if...** - You are 18 or older - You have had Type 2 diabetes for at least 1 year - You have been using insulin for at least 6 months - Your blood sugar control is not well-managed (HbA1c of 7.5% or higher) - You have been using the FreeStyle Libre 2 sensor for at least 3 months - You are interested in switching to the Dexcom G7 real-time sensor **You may NOT be eligible if...** - You have used a real-time continuous glucose monitor in the past 12 months - You recently changed or plan to change your diabetes medications or insulin dose significantly - You are pregnant or planning to become pregnant - You use an insulin pump Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEreal-time continuous glucose monitor

Individuals who switched from using isCGM to rtCGM


Locations(1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, Canada

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NCT06805786


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