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)

NCT06837103 | Recruiting

• 1 other identifier: REAL isCGM T2D
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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%).

Conditions

Type 2 Diabetes

Keywords

continuous glucose monitoring; type 2 diabetes; time in range; HbA1c

Outcome Measures

Primary Outcomes (1)

• 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

  from enrollment to 3-6 month follow up

Secondary Outcomes (22)

• Change in Weight

  from enrollment to 3-6 month follow up

• Change in BMI

  from enrollment to 3-6 month follow up

• Change in Blood Pressure

  from enrollment to 3-6 month follow up

• Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up

  from enrollment to 3-6 month follow up

• Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week

  from enrollment to 3-6 month follow up

Other Outcomes (2)

• Change in HbA1c by Age

  assessed at 3-6 month follow-up

• Change in HbA1c by Baseline HbA1c

  assessed at 3-6 month follow-up

Study Arms (3)

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

Device: Intermittently Scanned Continuous Glucose Monitor

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

Device: Intermittently Scanned Continuous Glucose Monitor

Interventions

Intermittently Scanned Continuous Glucose Monitor DEVICE

intervention used by the isCGM and isCGM+Coaching groups

isCGM Group; isCGM+Coaching Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Sun Life Assurance Company of Canada: collaborator

Study Sites (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 20, 2025
• Study Start: April 9, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)