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) (REAL isCGM T2D)

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

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%).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Intermittently Scanned Continuous Glucose Monitor

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3E8
      • Recruiting
      • LMC Diabetes & Endocrinology Ltd.
      • Contact: Manager, Data Science; Phone Number: 4166452929; Email: lisa.chu@lmc.ca
      • Contact: Research Assistant, Data Science; Email: giovana.romero@lmc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; intervention used by the isCGM and isCGM+Coaching groups
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; intervention used by the isCGM and isCGM+Coaching groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessed at 3-6 month follow-up
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)	assessed at 3-6 month follow-up

Collaborators and Investigators

• Sponsor: LMC Diabetes & Endocrinology Ltd.
• Collaborators: Sun Life Assurance Company of Canada

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HbA1c; type 2 diabetes; continuous glucose monitoring; time in range
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: REAL isCGM T2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a real-world study using data from a national Diabetes Registry. IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No