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)
NCT ID: NCT06837103
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2025-04-09
2026-05-31
Brief Summary
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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%).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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isCGM Group
Adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation
Intermittently Scanned Continuous Glucose Monitor
intervention used by the isCGM and isCGM+Coaching groups
CBG Group
Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor
No interventions assigned to this group
isCGM+Coaching Group
Adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete 2 or more diabetes coaching program consultations
Intermittently Scanned Continuous Glucose Monitor
intervention used by the isCGM and isCGM+Coaching groups
Interventions
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Intermittently Scanned Continuous Glucose Monitor
intervention used by the isCGM and isCGM+Coaching groups
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sun Life Assurance Company of Canada
UNKNOWN
LMC Diabetes & Endocrinology Ltd.
OTHER
Responsible Party
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Locations
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LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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REAL isCGM T2D
Identifier Type: -
Identifier Source: org_study_id
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