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

NCT07157384 | Not Yet Recruiting

• 1 other identifier: REMIT2D isCGM
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 6

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.

Conditions

Type 2 Diabetes

Keywords

low-calorie meal replacement; remission; intermittently scanned continuous glucose monitoring; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who achieve remission at the end of phase 2

  The primary objective is to compare the percentage of participants who achieve remission of T2D (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 isCGM vs. CBG monitoring, when combined with LCMR and DSME

  from enrollment to end of phase 2 (18-30 weeks)

Secondary Outcomes (32)

• Proportion of participants achieving remission at the end of phase 1

  from enrollment to end of phase 1 (12-24 weeks)

• Proportion of participants achieving remission to prediabetes at the end of phase 1

  from enrollment to end of phase 1 (12-24 weeks)

• Proportion of participants achieving remission to normoglycemia at the end of phase 1

  from enrollment to end of phase 1 (12-24 weeks)

• Follow-up and change in HbA1c for the participants who did not initiate/reinitiate antihyperglycemic agents at the end of Phase 1

  from enrollment to end of Phase 1 (12-24 weeks)

• Adherence to low calorie meal replacement at the end of phase 1

  from enrollment to end of Phase 1 (12-24 weeks)

Other Outcomes (1)

• Evaluating isCGM metrics at the end of phase 3 between isCGM+ LCMR+ DSME and CBG+ LMCR+ DSME

  End of Phase 3 (30-44 weeks)

Study Arms (2)

isCGM + LCMR + DSME

EXPERIMENTAL

Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education

Dietary Supplement: Low calorie meal replacement plan; Behavioral: Diabetes self management education; Device: Intermittently scanned continuous glucose monitoring

CBG + LCMR + DSME

ACTIVE COMPARATOR

Group using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education

Dietary Supplement: Low calorie meal replacement plan; Behavioral: Diabetes self management education; Device: capillary blood glucose monitoring

Interventions

Low calorie meal replacement plan DIETARY_SUPPLEMENT

intervention provided to both arms in 2 out of the 3 study phases: Phase 1 (total dietary replacement) and Phase 2 (food re-introduction)

CBG + LCMR + DSME; isCGM + LCMR + DSME

Diabetes self management education BEHAVIORAL

intervention provided to both arms throughout study conducted as in-person session and telephone sessions

CBG + LCMR + DSME; isCGM + LCMR + DSME

Intermittently scanned continuous glucose monitoring DEVICE

intervention provided to the intervention arm only: isCGM + LCMR + DSME

isCGM + LCMR + DSME

capillary blood glucose monitoring DEVICE

intervention provided to the control arm only: CBG + LCMR + DSME

CBG + LCMR + DSME

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Abbott Diabetes Care: collaborator

Study Sites (6)

LMC Brampton

Brampton, Ontario, Canada

Location

LMC Etobicoke

Etobicoke, Ontario, Canada

Location

LMC Oakville

Oakville, Ontario, Canada

Location

LMC Ottawa

Ottawa, Ontario, Canada

Location

LMC Bayview

Toronto, Ontario, M4G 3E8, Canada

Location

LMC Vaughan

Vaughan, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Manager, Data Science

CONTACT

14166452929; lisa.chu@lmc.ca

Research Assistant, Data Science

CONTACT

giovana.romero@lmc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)