Status:
NOT_YET_RECRUITING
REMIssion of Type 2 Diabetes Between Intermittently Scanned Continuous Glucose Monitoring and Capillary Blood Glucose Monitoring When Added to Low-calorie Meal Replacement and Diabetes Self-management Education
Lead Sponsor:
LMC Diabetes & Endocrinology Ltd.
Collaborating Sponsors:
Abbott Diabetes Care
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of the study is to evaluate the effectiveness of intermittently scanned continuous glucose monitoring compared to capillary blood glucose monitoring among people with type 2 diabetes initiati...
Eligibility Criteria
Inclusion
- Age 18-75 years old
- T2D treated with ≤ 3 non-insulin antihyperglycemic agents
- A clinical diagnosis of T2D for \> 6 months and ≤ 6 years ago
- HbA1c 6.0-9.0% on 2 or 3 antihyperglycemic agents, HbA1c 6.5-9.0% on 1 antihyperglycemic agent, or HbA1c 7.0-9.0% on 0 antihyperglycemic agents
- BMI 27-44.9 kg/m2
- Not currently using a real-time CGM or isCGM
- Willing to adhere to LCMR and initiate isCGM or CBG monitoring, and capable to do so as judged by investigator
Exclusion
- Current or prior use of insulin (except for prior management of gestational diabetes mellitus)
- Are pregnant or breastfeeding, or planning to become pregnant in the next 2 years
- Severe or progressive retinopathy
- Have a history of cardiovascular disease: coronary artery disease (CAD): prior myocardial infarction, previous unstable angina, documented CAD on angiography with stenosis \>50%, imaging evidence of myocardial ischemia, coronary revascularization), peripheral arterial disease (lower extremity stenosis exceeding 50%, previous limb angioplasty, stenting or bypass surgery; or previous limb or foot amputation due to circulatory insufficiency or ankle brachial index of \< 0.9 in at least one limb.), cerebrovascular disease (history of ischemic or hemorrhagic stroke or \> 50% carotid stenosis), or heart failure
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 or eGFR 60-90 ml/min/1.73 m2 with urine albumin to creatinine ratio (uACR) \> 20 mg/mmol (any previously resolved macroalbuminuria will be considered as a reason for ineligibility, at the investigator's discretion)
- Active binge eating disorder or other eating disorder
- Uncontrolled mental health disorder
- Current use of atypical antipsychotic or corticosteroid
- Use of other implanted medical devices, such as pacemakers
- Participant whose circumstance is deemed by investigator to be unadvisable, unsafe, or unlikely to be capable of adhering to LCMR and/or isCGM/CBG monitoring during the study period
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT07157384
Start Date
September 1 2025
End Date
June 1 2027
Last Update
September 5 2025
Active Locations (6)
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1
LMC Brampton
Brampton, Ontario, Canada
2
LMC Etobicoke
Etobicoke, Ontario, Canada
3
LMC Oakville
Oakville, Ontario, Canada
4
LMC Ottawa
Ottawa, Ontario, Canada