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

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

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

Sponsors & Collaborators

• Abbott Diabetes Care

  collaborator INDUSTRY

• LMC Diabetes & Endocrinology Ltd.

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2027-03-31

Completion

2027-06-30

Countries

• Canada

Study Locations