Evaluating glucose monitoring and pharmacist coaching for managing type 2 diabetes
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
LMC Diabetes & Endocrinology Ltd. · NCT06837103
This study is testing if using a special glucose monitor along with help from a pharmacist can improve diabetes management for adults with type 2 diabetes compared to regular blood sugar checks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMC Diabetes & Endocrinology Ltd. (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06837103 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diabetes management outcomes in insulin-naïve adults with type 2 diabetes by comparing the effects of intermittently scanned continuous glucose monitoring (isCGM) combined with pharmacist-led coaching against traditional capillary blood glucose (CBG) monitoring. Participants will be followed for 3-6 months to evaluate changes in HbA1c levels and other metabolic outcomes. The study will also explore patient-reported outcomes and the number of antihyperglycemic agents prescribed. The research is conducted in a specialist endocrinology setting in Canada.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of type 2 diabetes for at least one year, currently using antihyperglycemic agents, and not on insulin.
Not a fit: Patients who have a history of insulin use or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved diabetes management and better health outcomes for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- LMC Diabetes & Endocrinology Ltd. — Toronto, Ontario, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, continuous glucose monitoring, type 2 diabetes, time in range, HbA1c