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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
LMC Diabetes & Endocrinology Ltd.
RECRUITING
Toronto
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2026-05
Participants
Target number of participants: 250
Treatments
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
CBG Group
Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor
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
Related Therapeutic Areas
Sponsors
Leads: LMC Diabetes & Endocrinology Ltd.
Collaborators: Sun Life Assurance Company of Canada

This content was sourced from clinicaltrials.gov