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)

Recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06837103
• Lead Sponsor: LMC Diabetes & Endocrinology Ltd.

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%).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-20
• Status Verified: 2025-04
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	from enrollment to 3-6 month follow up	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

Secondary Outcome Measures

Name	Time	Method
Change in BMI	from enrollment to 3-6 month follow up	Evaluate the change in body mass index (BMI) in the isCGM and CBG cohorts
Change in Blood Pressure	from enrollment to 3-6 month follow up	Evaluate Change in Blood Pressure in only the isCGM+Coaching cohort
Mean glucose	from enrollment to 3-6 month follow up	Evaluate mean glucose in the isCGM and isCGM+Coaching cohorts
Glycemic variability	from enrollment to 3-6 month follow up	Evaluate glycemic variability reported as SD and CV in the isCGM and isCGM+Coaching cohorts
Number of isCGM discontinuations	assessed at 3-6 month follow-up	Evaluate the number of isCGM discontinuations in the isCGM and isCGM+Coaching cohorts only at follow-up
Change in Weight	from enrollment to 3-6 month follow up	Evaluate change in weight in only the isCGM+Coaching cohort
Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up	from enrollment to 3-6 month follow up	Evaluate the proportion of participants achieving HbA1c ≤ 7.0% at follow-up in the isCGM and CBG cohort
Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week	from enrollment to 3-6 month follow up	Evaluate the proportion of participants with ≥1 self-reported hypoglycemic event per week in the isCGM and CBG cohort
Percent Time in Range (TIR)	from enrollment to 3-6 month follow up	Evaluate percent time in range (3.9 to 10.0 mmol/L) in the isCGM and isCGM+Coaching cohorts
Percent Time Below Range (TBR)	from enrollment to 3-6 month follow up	Evaluate percent time below range (\< 3.9 mmol/L) in the isCGM and isCGM+Coaching cohorts
Percent Time Below Range (TBR) in Level 2 Hypoglycemia	from enrollment to 3-6 month follow up	Evaluate Percent TBR in level 2 hypoglycemia (\< 3.0 mmol/L) in the isCGM and isCGM+Coaching cohorts
Percent Time Above Range (TAR)	from enrollment to 3-6 month follow up	Evaluate Percent TAR (\> 10.0 mmol/L) in the isCGM and isCGM+Coaching cohorts
Estimated Glucose Management Indicator (eGMI)	from enrollment to 3-6 month follow up	Evaluate the Estimated Glucose Management Indicator (eGMI) in the isCGM and isCGM+Coaching cohorts
Glucose monitoring device satisfaction	from enrollment to 3-6 month follow up	Evaluate glucose monitoring device satisfaction measured by the Glucose Monitoring System Satisfaction Scale (GMSS) in the isCGM and isCGM+Coaching cohorts
Proportion of participants achieving HbA1c ≤ 7.0%	assessed at 3-6 month follow-up	Evaluate proportion of participants achieving HbA1c ≤ 7.0% in the isCGM and isCGM+Coaching cohorts at follow-up only
Percent sensor capture	from enrollment to 3-6 month follow up	Evaluate percent sensor capture in the isCGM and isCGM+Coaching cohorts
Number of diabetes coaching program discontinuations	from enrollment to 3-6 month follow up	Evaluate the number of diabetes coaching program discontinuations, measured by the Diabetes Coaching Program survey in the isCGM and isCGM+Coaching cohorts
Psychological distress	from enrollment to 3-6 month follow up	Evaluate psychological distress measured by the Diabetes Distress Scale (DDS) in the isCGM and isCGM+Coaching cohorts
Change in Body Mass Index (BMI)	from enrollment to 3-6 month follow up	Evaluate the change in body mass index in only the isCGM+Coaching cohort
Proportion of participants with ≥1 self-reported hypoglycemic event per week	from enrollment to 3-6 month follow up	Evaluate the proportion of participants with ≥1 self-reported hypoglycemic event per week in the isCGM+Coaching cohort only

Trial Locations

Locations (1)

LMC Diabetes & Endocrinology Ltd.; 🇨🇦 Toronto, Ontario, Canada