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
NCT ID: NCT07157384
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
176 participants
INTERVENTIONAL
2025-09-30
2027-06-30
Brief Summary
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The Investigators hypothesize that the use of intermittently scanned continuous glucose monitoring will improve the percentage of participants achieving remission of type 2 diabetes (remission to prediabetes or remission to normoglycemia), among adults with type 2 diabetes starting low calorie meal replacement and diabetes self-management education compared to a control group using capillary blood glucose monitoring at 18-30 weeks follow-up (end of Phase 2).
The primary outcome of the study is to compare the percentage of participants who achieve remission of type 2 diabetes (remission to prediabetes with HbA1c 6.0% to 6.4% or remission to normoglycemia with HbA1c \< 6.0% using no antihyperglycemic agents for ≥ 3 consecutive months) at 18-30 weeks follow-up between intermittently scanned continuous glucose monitoring vs. capillary blood glucose monitoring, when combined with low calorie meal replacement and diabetes self-management education.
Participants in both arms complete 3 phases of the study. Phase 1: total dietary replacement, Phase 2: food re-introduction and Phase 3: remission, while receiving diabetes self-management education sessions over a span of 18 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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isCGM + LCMR + DSME
Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education
Low calorie meal replacement plan
intervention provided to both arms in 2 out of the 3 study phases: Phase 1 (total dietary replacement) and Phase 2 (food re-introduction)
Diabetes self management education
intervention provided to both arms throughout study conducted as in-person session and telephone sessions
Intermittently scanned continuous glucose monitoring
intervention provided to the intervention arm only: isCGM + LCMR + DSME
CBG + LCMR + DSME
Group using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education
Low calorie meal replacement plan
intervention provided to both arms in 2 out of the 3 study phases: Phase 1 (total dietary replacement) and Phase 2 (food re-introduction)
Diabetes self management education
intervention provided to both arms throughout study conducted as in-person session and telephone sessions
capillary blood glucose monitoring
intervention provided to the control arm only: CBG + LCMR + DSME
Interventions
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Low calorie meal replacement plan
intervention provided to both arms in 2 out of the 3 study phases: Phase 1 (total dietary replacement) and Phase 2 (food re-introduction)
Diabetes self management education
intervention provided to both arms throughout study conducted as in-person session and telephone sessions
Intermittently scanned continuous glucose monitoring
intervention provided to the intervention arm only: isCGM + LCMR + DSME
capillary blood glucose monitoring
intervention provided to the control arm only: CBG + LCMR + DSME
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Abbott Diabetes Care
INDUSTRY
LMC Diabetes & Endocrinology Ltd.
OTHER
Responsible Party
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Locations
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LMC Brampton
Brampton, Ontario, Canada
LMC Etobicoke
Etobicoke, Ontario, Canada
LMC Oakville
Oakville, Ontario, Canada
LMC Ottawa
Ottawa, Ontario, Canada
LMC Bayview
Toronto, Ontario, Canada
LMC Vaughan
Vaughan, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REMIT2D isCGM
Identifier Type: -
Identifier Source: org_study_id
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