Clinical trial 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)
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitoring
type 2 diabetes
time in range
HbA1c
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: Sun Life Assurance Company of Canada
First posted: 2025-02-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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%).


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: from enrollment to 3-6 month follow up
Secondary outcomes:
measure: Change in Weight
timeFrame: from enrollment to 3-6 month follow up
measure: Change in BMI
timeFrame: from enrollment to 3-6 month follow up
measure: Change in Blood Pressure
timeFrame: from enrollment to 3-6 month follow up
measure: Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up
timeFrame: from enrollment to 3-6 month follow up
measure: Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week
timeFrame: from enrollment to 3-6 month follow up
measure: Percent Time in Range (TIR)
timeFrame: from enrollment to 3-6 month follow up
measure: Percent Time Below Range (TBR)
timeFrame: from enrollment to 3-6 month follow up
measure: Percent Time Below Range (TBR) in Level 2 Hypoglycemia
timeFrame: from enrollment to 3-6 month follow up
measure: Percent Time Above Range (TAR)
timeFrame: from enrollment to 3-6 month follow up
measure: Estimated Glucose Management Indicator (eGMI)
timeFrame: from enrollment to 3-6 month follow up
measure: Mean glucose
timeFrame: from enrollment to 3-6 month follow up
measure: Glycemic variability
timeFrame: from enrollment to 3-6 month follow up
measure: Percent sensor capture
timeFrame: from enrollment to 3-6 month follow up
measure: Number of isCGM discontinuations
timeFrame: assessed at 3-6 month follow-up
measure: Number of diabetes coaching program discontinuations
timeFrame: from enrollment to 3-6 month follow up
measure: Psychological distress
timeFrame: from enrollment to 3-6 month follow up
measure: Glucose monitoring device satisfaction
timeFrame: from enrollment to 3-6 month follow up
measure: Proportion of participants achieving HbA1c ≤ 7.0%
timeFrame: assessed at 3-6 month follow-up
measure: Change in Weight
timeFrame: from enrollment to 3-6 month follow up
measure: Change in Body Mass Index (BMI)
timeFrame: from enrollment to 3-6 month follow up
measure: Change in Blood Pressure
timeFrame: from enrollment to 3-6 month follow up
measure: Proportion of participants with ≥1 self-reported hypoglycemic event per week
timeFrame: from enrollment to 3-6 month follow up
Other outcomes:
measure: Change in HbA1c by Age
timeFrame: assessed at 3-6 month follow-up
measure: Change in HbA1c by Baseline HbA1c
timeFrame: assessed at 3-6 month follow-up
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Endocrinology Ltd.
state: Ontario
Study officials:
References: