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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittently Scanned Continuous Glucose Monitor.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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%).
Interventions
- Device Intermittently Scanned Continuous Glucose Monitor
intervention used by the isCGM and isCGM+Coaching groups
Primary outcome measures
- Change in HbA1c [Time frame: from enrollment to 3-6 month follow up]
Secondary outcome measures (12)
- Change in Weight [Time frame: from enrollment to 3-6 month follow up]
- Change in BMI [Time frame: from enrollment to 3-6 month follow up]
- Change in Blood Pressure [Time frame: from enrollment to 3-6 month follow up]
- Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up [Time frame: from enrollment to 3-6 month follow up]
- Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week [Time frame: from enrollment to 3-6 month follow up]
- Percent Time in Range (TIR) [Time frame: from enrollment to 3-6 month follow up]
- Percent Time Below Range (TBR) [Time frame: from enrollment to 3-6 month follow up]
- Percent Time Below Range (TBR) in Level 2 Hypoglycemia [Time frame: from enrollment to 3-6 month follow up]
- Percent Time Above Range (TAR) [Time frame: from enrollment to 3-6 month follow up]
- Estimated Glucose Management Indicator (eGMI) [Time frame: from enrollment to 3-6 month follow up]
- Mean glucose [Time frame: from enrollment to 3-6 month follow up]
- Glycemic variability [Time frame: from enrollment to 3-6 month follow up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- LMC Diabetes & Endocrinology Ltd. — Toronto
Identifiers
NCT: NCT06837103 · REAL isCGM T2D