Actively Recruiting
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)
Led by LMC Diabetes & Endocrinology Ltd. · Updated on 2025-05-04
250
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
L
LMC Diabetes & Endocrinology Ltd.
Lead Sponsor
S
Sun Life Assurance Company of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Clinical diagnosis of type 2 diabetes for at least one year
- Using at least one non-insulin antihyperglycemic agent
- Status as a Sun Life group benefits member, initiating isCGM device through Lumino Health Pharmacy with one pharmacist consultation (isCGM cohort) or two or more diabetes coaching consultations (isCGM+coaching cohort); or has private health insurance and uses capillary blood glucose monitoring (CBG cohort)
- Baseline HbA1c of 7.0% or higher
- At least one HbA1c value within 6 months before the study start
- Exclusive use of isCGM device for at least 3 months
- Provided informed consent
You will not qualify if you...
- History of insulin use
- Pregnant or breastfeeding at enrollment or becoming pregnant during the study
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
- Previously used real-time or intermittently scanned continuous glucose monitoring for more than 3 months
- Recent or expected changes to antihyperglycemic medications or doses within 30 days before study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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