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%).
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)
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
The study population will be 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 (isCGM cohort) or complete 2 or more diabetes coaching program consultations (isCGM+coaching cohort), or use a CBG monitor (CBG cohort)
Cohort
Prospective
Intermittently Scanned Continuous Glucose Monitor
Deviceintervention used by the isCGM and isCGM+Coaching groups
Change in HbA1c
Evaluate the change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D
Change in Weight
Evaluate the change in weight in the isCGM and CBG cohorts
Change in BMI
Evaluate the change in body mass index (BMI) in the isCGM and CBG cohorts
Change in Blood Pressure
Evaluate the change in blood pressure in the isCGM and CBG cohorts
Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up
Evaluate the proportion of participants achieving HbA1c ≤ 7.0% at follow-up in the isCGM and CBG cohort
Change in HbA1c by Age
Evaluate change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D by age \< 65 years old vs ≥ 65 years old subgroups
Change in HbA1c by Baseline HbA1c
Evaluate change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D by baseline HbA1c (\< 8.5% vs ≥ 8.5% subgroups)
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LMC Diabetes & Endocrinology Ltd.
Lead sponsor
Sun Life Assurance Company of Canada
Collaborator
