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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)

Recruitingn/aAges 18 Years - anyAllLMC Diabetes & Endocrinology Ltd.
NCT06837103 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * Clinical diagnosis of T2D ≥ one year * Using at least one AHA * Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort) * Baseline HbA1c ≥ 7.0% * ≥ 1 HbA1c value up to 6 months prior to index date * Exclusive use of isCGM for ≥ 3 months * Informed consent Exclusion Criteria: * Have a history of insulin use * Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study * Have an estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 * Previously used rtCGM or isCGM for \> 3 months * Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
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What it tests

  • Intermittently Scanned Continuous Glucose Monitor
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Where

1 site
LMC Diabetes & Endocrinology Ltd.
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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