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NCT Number: NCT06837103

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)

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%).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G 3E8, Canada

Location status: Recruiting

Location contact

Manager, Data Science

CONTACT

[email protected]

4166452929

Research Assistant, Data Science

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittently Scanned Continuous Glucose Monitor

Device

intervention used by the isCGM and isCGM+Coaching groups

Primary outcomes

  1. Change in HbA1c

    Time frame: 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 outcomes

  1. Change in Weight

    Time frame: from enrollment to 3-6 month follow up

    Evaluate the change in weight in the isCGM and CBG cohorts

  2. Change in BMI

    Time frame: from enrollment to 3-6 month follow up

    Evaluate the change in body mass index (BMI) in the isCGM and CBG cohorts

  3. Change in Blood Pressure

    Time frame: from enrollment to 3-6 month follow up

    Evaluate the change in blood pressure in the isCGM and CBG cohorts

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

    Time frame: 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

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

    Time frame: 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

  6. Percent Time in Range (TIR)

    Time frame: 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

  7. Percent Time Below Range (TBR)

    Time frame: from enrollment to 3-6 month follow up

    Evaluate percent time below range (< 3.9 mmol/L) in the isCGM and isCGM+Coaching cohorts

  8. Percent Time Below Range (TBR) in Level 2 Hypoglycemia

    Time frame: 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

  9. Percent Time Above Range (TAR)

    Time frame: from enrollment to 3-6 month follow up

    Evaluate Percent TAR (> 10.0 mmol/L) in the isCGM and isCGM+Coaching cohorts

  10. Estimated Glucose Management Indicator (eGMI)

    Time frame: from enrollment to 3-6 month follow up

    Evaluate the Estimated Glucose Management Indicator (eGMI) in the isCGM and isCGM+Coaching cohorts

  11. Mean glucose

    Time frame: from enrollment to 3-6 month follow up

    Evaluate mean glucose in the isCGM and isCGM+Coaching cohorts

  12. Glycemic variability

    Time frame: from enrollment to 3-6 month follow up

    Evaluate glycemic variability reported as SD and CV in the isCGM and isCGM+Coaching cohorts

  13. Percent sensor capture

    Time frame: from enrollment to 3-6 month follow up

    Evaluate percent sensor capture in the isCGM and isCGM+Coaching cohorts

  14. Number of isCGM discontinuations

    Time frame: assessed at 3-6 month follow-up

    Evaluate the number of isCGM discontinuations in the isCGM and isCGM+Coaching cohorts only at follow-up

  15. Number of diabetes coaching program discontinuations

    Time frame: 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

  16. Psychological distress

    Time frame: 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

  17. Glucose monitoring device satisfaction

    Time frame: 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

  18. Proportion of participants achieving HbA1c ≤ 7.0%

    Time frame: 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

  19. Change in Weight

    Time frame: from enrollment to 3-6 month follow up

    Evaluate change in weight in only the isCGM+Coaching cohort

  20. Change in Body Mass Index (BMI)

    Time frame: from enrollment to 3-6 month follow up

    Evaluate the change in body mass index in only the isCGM+Coaching cohort

  21. Change in Blood Pressure

    Time frame: from enrollment to 3-6 month follow up

    Evaluate Change in Blood Pressure in only the isCGM+Coaching cohort

  22. Proportion of participants with ≥1 self-reported hypoglycemic event per week

    Time frame: 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

Other outcomes

  1. Change in HbA1c by Age

    Time frame: assessed at 3-6 month follow-up

    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

  2. Change in HbA1c by Baseline HbA1c

    Time frame: assessed at 3-6 month follow-up

    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)

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Collaborators

  • Sun Life Assurance Company of Canada

Registry information

Official study title

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

Acronym: REAL isCGM T2D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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