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)

LMC Diabetes & Endocrinology Ltd.

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Device: Intermittently Scanned Continuous Glucose Monitor

Study type: Observational

Funder types: Other

Identifiers

NCT06837103

REAL isCGM T2D

Details and patient eligibility

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%).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 3 patient groups

isCGM Group

Description:

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

Treatment:

Device: Intermittently Scanned Continuous Glucose Monitor

CBG Group

Description:

Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor

isCGM+Coaching Group

Description:

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

Treatment:

Device: Intermittently Scanned Continuous Glucose Monitor