NCT07157384

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: LMC Diabetes & Endocrinology Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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)
BEHAVIORAL	Diabetes self management education	intervention provided to both arms throughout study conducted as in-person session and telephone sessions
DEVICE	Intermittently scanned continuous glucose monitoring	intervention provided to the intervention arm only: isCGM + LCMR + DSME
DEVICE	capillary blood glucose monitoring	intervention provided to the control arm only: CBG + LCMR + DSME

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

6 sites across 1 country: Canada