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ClinicalTrials.gov ID

NCT07157384

Lead Sponsor

LMC Diabetes & Endocrinology Ltd.OTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

176Estimated

Last Update Posted

Sep 5, 2025Actual

Start Date

Sep 2025Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Jun 2027Estimated

Official Title

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

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 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.

• Type 2 Diabetes

• Low calorie meal replacement plan
• Diabetes self management education
• Intermittently scanned continuous glucose monitoring
• capillary blood glucose monitoring

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

LMC Diabetes & Endocrinology Ltd.OTHER

Collaborators

Abbott Diabetes CareINDUSTRY

lisa.chu@lmc.ca

lisa.chu@lmc.ca

lisa.chu@lmc.ca

lisa.chu@lmc.ca14166452929

lisa.chu@lmc.ca