NCT07157384Not 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
Randomized Controlled Trial Comparing 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: The REMIT2D isCGM Trial
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 initiating low calorie meal replacement plus diabetes self-management education in improving the proportion of patients achieving remission of type 2 diabetes. This is an open-label randomized controlled trial with 2 treatment arms randomized in a 1:1 manner. 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07157384
What you commit to
- Study type: Interventional
- Planned participants: 176
- From 1 Sept 2025 to the primary completion date, 31 Mar 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior use of insulin (except for prior management of gestational diabetes mellitus)
- 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
- Current use of atypical antipsychotic or corticosteroid
Other illness
- Active binge eating disorder or other eating disorder
- Uncontrolled mental health disorder
Lab values
- 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)
Other
- Are pregnant or breastfeeding, or planning to become pregnant in the next 2 years
- Severe or progressive retinopathy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LMC Brampton Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| LMC Etobicoke Coordinator of this site? Confirm its status | Etobicoke | Canada | Unknown status |
| LMC Oakville Coordinator of this site? Confirm its status | Oakville | Canada | Unknown status |
| LMC Ottawa Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| LMC Bayview Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| LMC Vaughan Coordinator of this site? Confirm its status | Vaughan | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.