RecruitingNCT06837103

Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Not Using Insulin (REAL isCGM T2D)

Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Using Non-insulin Antihyperglycemic Agents


Sponsor

LMC Diabetes & Endocrinology Ltd.

Enrollment

250 participants

Start Date

Apr 9, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (isCGM) plus one pharmacist consultation session compared with capillary blood glucose (CBG) monitoring among insulin-naïve adults with type 2 diabetes (T2D) in a specialist endocrinology clinical setting in Canada. Primary Outcome - To evaluate change in HbA1c at 3-6 months follow-up after initiating isCGM plus one pharmacist consultation (isCGM cohort) compared with CBG monitoring (CBG cohort) among insulin-naïve adults with T2D. Secondary Outcomes - To determine the change in metabolic outcomes and patient reported outcomes (PROs) and number of non-insulin antihyperglycemic agents (AHAs) prescribed from baseline to 3-6 months (± 6 weeks) in the isCGM cohort compared to the CBG cohort. Another secondary outcome is to assess isCGM metrics and number of isCGM discontinuations in the isCGM cohort at 3-6 months (± 6 weeks) compared to baseline. Additionally the study will describe and/or evaluate glycemic and metabolic outcomes, and PROs in participants who initiate an isCGM device and opt to enroll in a diabetes coaching program (isCGM+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks). Exploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (\< 65 years old vs ≥ 65 years old) and baseline HbA1c (\< 8.5% vs ≥ 8.5%).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study compares three approaches to monitoring blood sugar in people with type 2 diabetes who are not on insulin: a flash glucose monitor (isCGM), isCGM with pharmacist coaching, or traditional fingerstick blood glucose monitoring. It looks at whether using a sensor and pharmacist support improves HbA1c (long-term blood sugar control). **You may be eligible if...** - You are 18 or older with a type 2 diabetes diagnosis for at least 1 year - You take at least one diabetes medication (other than insulin) - Your HbA1c is 7.0% or above at the start - You meet the insurance and pharmacy requirements for your assigned group - You have used a flash glucose monitor for at least 3 months (isCGM cohort) or completed pharmacist consultations (coaching cohort) **You may NOT be eligible if...** - You use insulin currently or have a history of insulin use - You are pregnant or breastfeeding - You have significantly reduced kidney function (eGFR below 30) - You have type 1 diabetes 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

DEVICEIntermittently Scanned Continuous Glucose Monitor

intervention used by the isCGM and isCGM+Coaching groups


Locations(1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, Canada

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NCT06837103


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