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 (REMIT2D isCGM)

August 28, 2025 updated by: LMC Diabetes & Endocrinology Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Manager, Data Science
  • Phone Number: 14166452929
  • Email: lisa.chu@lmc.ca

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada
        • LMC Brampton
        • Principal Investigator:
          • Harpreet Bajaj, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Nadeem Aslam, MD
      • Etobicoke, Ontario, Canada
      • Oakville, Ontario, Canada
        • LMC Oakville
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alexander Abitbol, MD
        • Sub-Investigator:
          • David Twum-Barima, MD
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada, M4G 3E8
        • LMC Bayview
        • Principal Investigator:
          • Alexander Abitbol, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ronnie Aronson, MD
      • Vaughan, Ontario, Canada
        • LMC Vaughan
        • Contact:
        • Contact:
        • Sub-Investigator:
          • David Sionit, MD
        • Sub-Investigator:
          • Chris D'Sylva, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: isCGM + LCMR + DSME
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
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
Active Comparator: CBG + LCMR + DSME
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
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: capillary blood glucose monitoring
intervention provided to the control arm only: CBG + LCMR + DSME

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants who achieve remission at the end of phase 2
Time Frame: from enrollment to end of phase 2 (18-30 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving remission at the end of phase 1
Time Frame: from enrollment to end of phase 1 (12-24 weeks)
Evaluating the proportion of participants achieving 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 12-24 weeks follow-up between intervention and control (isCGM vs. CBG monitoring, when combined with LCMR and DSME)
from enrollment to end of phase 1 (12-24 weeks)
Proportion of participants achieving remission to prediabetes at the end of phase 1
Time Frame: from enrollment to end of phase 1 (12-24 weeks)
Evaluating the proportion of participants between intervention and control groups achieving remission to prediabetes (HbA1c 6.0% to 6.4%) using no antihyperglycemic agents for ≥ 3 consecutive months at weeks 12-24 weeks follow-up
from enrollment to end of phase 1 (12-24 weeks)
Proportion of participants achieving remission to normoglycemia at the end of phase 1
Time Frame: from enrollment to end of phase 1 (12-24 weeks)
Evaluating the proportion of participants between the intervention and control group achieving remission to normoglycemia (HbA1c < 6.0%) using no antihyperglycemic agents for ≥ 3 consecutive months at weeks 12-24 weeks follow-up
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
Time Frame: from enrollment to end of Phase 1 (12-24 weeks)
comparing between intervention and control (isCGM vs. CBG monitoring, when combined with LCMR and DSME) the follow-up HbA1c (%) and the change in HbA1c (%) at the end of Phase 1 (12-24 weeks) for participants who did not initiate/reinitiate antihyperglycemic agents
from enrollment to end of Phase 1 (12-24 weeks)
Adherence to low calorie meal replacement at the end of phase 1
Time Frame: from enrollment to end of Phase 1 (12-24 weeks)
Comparing the adherence to low calorie meal replacement (LCMR), defined as a score of 3, 4 or 5 out of 5 for LCMR adherence measured using the adherence questionnaire between the intervention and the control group at the end of phase 1 (12-24 weeks). A higher score on the scale indicates better adherence.
from enrollment to end of Phase 1 (12-24 weeks)
Percentage relapse at the end of Phase 1
Time Frame: from enrollment to end of Phase 1 (12-24 weeks)
comparing the number of participants between intervention and control group that relapse during Phase 1, reported as a percentage. Relapse is defined as weight gain > 2 kg from baseline body weight, HbA1c > 9%, fasting glucose > 11 mmol/L (on consecutive days, after first 4 weeks of LCMR), completely abandoning LCMR, and/or if participant needs to restart medications to lower their blood sugar (based on the doctor's recommendations).
from enrollment to end of Phase 1 (12-24 weeks)
Time spent in Phase 1
Time Frame: from enrollment to end of phase 1 (12-24 weeks)
Comparing the time spent in Phase 1 (12-24 weeks) between intervention and control group. Time spent will be measured in weeks
from enrollment to end of phase 1 (12-24 weeks)
Proportion of participants achieving remission to prediabetes at the end of phase 2
Time Frame: from enrollment to end of phase 2 (18-30 weeks)
Evaluating the proportion of participants between intervention and control groups achieving remission to prediabetes (HbA1c 6.0% to 6.4%) using no antihyperglycemic agents for ≥ 3 consecutive months at 18-30 weeks follow-up
from enrollment to end of phase 2 (18-30 weeks)
Proportion of participants achieving remission to normoglycemia at the end of phase 2
Time Frame: from enrollment to end of phase 2 (18-30 weeks)
Evaluating the proportion of participants between the intervention and control group achieving remission to normoglycemia (HbA1c < 6.0%) using no antihyperglycemic agents for ≥ 3 consecutive months at weeks 18-30 weeks follow-up
from enrollment to end of phase 2 (18-30 weeks)
Follow-up and change of scores for Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) scale at the end of phase 2
Time Frame: from enrollment to end of phase 2 (18-30 weeks)
Evaluating the follow-up and change in scores for the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) scale between the intervention and control group at the end of phase 2 ( 18-30 weeks). The DTSQs scale has 8 questions measured on a Likert scale from 6 (very satisfied) to 0 (very dissatisfied) about the participants satisfaction with their diabetes treatment in the last few weeks.
from enrollment to end of phase 2 (18-30 weeks)
Follow-up and change in scores for the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) scale at the end of phase 2
Time Frame: from enrollment to end of phase 2 (18-30 weeks)
Evaluating the follow-up and change in scores for the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) scale between the intervention and control group at the end of phase 2 (18-30 weeks). The DTSQc scale has 8 questions measured on a Likert scale from 3 (much more satisfied now) to -3 (much less satisfied now) about the participants satisfaction of their diabetes treatment in the past 4-7 months.
from enrollment to end of phase 2 (18-30 weeks)
Follow-up and change of scores in the Diabetes Distress scale (DDS) at the end of phase 2
Time Frame: from enrollment to end of phase 2 (18-30 weeks)
Evaluating the follow-up and change in scores in the Diabetes Distress scale (DDS) at the end of phase 2 (18-30 weeks) between intervention and control group. The DSS includes 17 questions measured on a Likert scale from 1 (not a problem) to 6 (a very serious problem) about the degree that diabetes has caused the participant distress in the past month. A higher score is reflective of more distress.
from enrollment to end of phase 2 (18-30 weeks)
Proportion of participants achieving remission of T2D at the end of phase 3
Time Frame: from enrollment to end of phase 3 (30-44 weeks)
Evaluating the proportion 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 30-44 weeks follow-up between intervention and control ( isCGM vs. CBG monitoring, when combined with LCMR and DSME)
from enrollment to end of phase 3 (30-44 weeks)
Proportion of participants achieving remission to prediabetes at the end of phase 3
Time Frame: from enrollment to end of phase 3 (30-44 weeks)
Evaluating the proportion of participants achieving remission to prediabetes (HbA1c 6.0% to 6.4% using no antihyperglycemic agents for ≥ 3 consecutive months) at 30-44 weeks between intervention and control group (isCGM vs. CBG monitoring, when combined with LCMR and DSME)
from enrollment to end of phase 3 (30-44 weeks)
Proportion of participants achieving remission to normoglycemia at the end of phase 3
Time Frame: from enrollment to end of phase 3 (30-44 weeks)
Evaluating the proportion of participants achieving remission to normoglycemia (HbA1c < 6.0% using no antihyperglycemic agents for ≥ 3 consecutive months) at 30-44 weeks follow-up between intervention and control group ( isCGM vs. CBG monitoring, when combined with LCMR and DSME)
from enrollment to end of phase 3 (30-44 weeks)
Evaluating the change in HbA1c at the end of phase 3
Time Frame: from enrollment to end of phase 3 (30-42 weeks)
Evaluating the change in HbA1c (%) at 30-44 weeks follow-up between intervention and control group
from enrollment to end of phase 3 (30-42 weeks)
Low Calorie Meal Replacement persistence at the end of Phase 3
Time Frame: End of Phase 3 (30-42 weeks)
Comparing the persistence to Low Calorie Meal Replacement (LCMR) in percentage between the intervention and the control group at the end of phase 3 (30-44 weeks).
End of Phase 3 (30-42 weeks)
Proportion of participants initiating/reinitiating antihyperglycemic agents at the end of phase 3
Time Frame: from enrollment to end of phase 3 ( 30-44 weeks)
Evaluating the proportion of participants initiating/reinitiating antihyperglycemic agents at the end of phase 3 (30-44 weeks) between the intervention and control group.
from enrollment to end of phase 3 ( 30-44 weeks)
Follow-up and change in body weight at the end of phase 3
Time Frame: from enrollment to end of phase 3 (30-44 weeks)
Evaluating the follow-up and change in body weight (kg) at the end of phase 3 (30-44 weeks) between the intervention and control group
from enrollment to end of phase 3 (30-44 weeks)
Follow-up and change in BMI at the end of phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the follow-up and change in BMI (kg/m^2) at the end of phase 3 ( 30-44 weeks) between the intervention and control group
from enrollment to end of Phase 3 (30-44 weeks)
Percent weight loss at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the percent weight loss at the end of Phase 3 (30-44 weeks) between the intervention and control group
from enrollment to end of Phase 3 (30-44 weeks)
Follow-up and change in scores for the Diabetes Treatment Satisfaction Questionnaire status version at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 ( 30-44 weeks)
Evaluating the follow-up and change in scores for the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) between the intervention and control group at the end of phase 3 (30-44 weeks). The DTSQs scale has 8 questions measured on a Likert scale from 6 (very satisfied) to 0 (very dissatisfied) about the participants satisfaction with their diabetes treatment in the last few weeks.
from enrollment to end of Phase 3 ( 30-44 weeks)
Follow-up and change in scores in the Diabetes Distress scale (DDS) at the end of phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the follow-up and change in scores in the Diabetes Distress scale (DDS) at the end of phase 3 (30-44 weeks) between intervention and control group. The DSS includes 17 questions measured on a Likert scale from 1 (not a problem) to 6 (a very serious problem) about the degree that diabetes has caused the participant distress in the past month. A higher score is reflective of more distress
from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time in Range (TIR) at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the change in percent TIR (3.9 to 10.0 mmol/L) at the end of phase 3 (30-44 weeks) from baseline between intervention and control group
from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Tight Time in Range (TITR) at the end of Phase 3
Time Frame: enrollment to end of Phase 3 (30-44 weeks)
Evaluating the change in percent TITR (3.9 to 7.8 mmol/L) at the end of phase 3 (30-44 weeks) from baseline between intervention and control group
enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time Below Range (TBR) at the end of Phase 3
Time Frame: from enrollment to end of phase 3 (30-44 weeks)
Evaluating the change in percent TBR (≤ 3.8 mmol/L) at the end of phase 3 (30-44 weeks) from baseline between intervention and control group
from enrollment to end of phase 3 (30-44 weeks)
Change in Percent Time Below Range Level 1 at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the change in percent TBR level 1 hypoglycemia range (3.0 to 3.8 mmol/L) at the end of phase 3 (30-44 weeks) from baseline between intervention and control group
from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time Below Range Level 2 at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the change in percent TBR level 2 hypoglycemia range (< 3.0 mmol/L)at the end of phase 3 (30-44 weeks) from baseline between intervention and control group
from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time Above Range (TAR) at the end of Phase 3
Time Frame: from enrollment to end of Phase 3
Evaluating the change in percent TAR (> 10.0 mmol/L) at the end of phase 3 (30-44 weeks) from baseline between intervention and control group
from enrollment to end of Phase 3
Change in mean glucose at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the change in mean glucose (mmol/L) at the end of phase 3 (30-44 weeks) from baseline between the intervention and control group.
from enrollment to end of Phase 3 (30-44 weeks)
Change in Glycemic Variability at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating change in glycemic variability (standard deviation and % coefficient of variation) from baseline to the end of Phase 3 (30-44 weeks) between the intervention and control group.
from enrollment to end of Phase 3 (30-44 weeks)
Change in Glucose Management Indicator at the end of Phase 3
Time Frame: from enrollment to end of Phase 3 (30-44 weeks)
Evaluating the change in Glucose management indicator, measured in percentage (%) between the intervention and control group from baseline to the end of Phase 3 (30-44 weeks)
from enrollment to end of Phase 3 (30-44 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluating isCGM metrics at the end of phase 3 between isCGM+ LCMR+ DSME and CBG+ LMCR+ DSME
Time Frame: End of Phase 3 (30-44 weeks)
Evaluating isCGM metrics (collected from a blinded isCGM) between isCGM vs. CBG monitoring, when combined with LCMR and DSME at 30-42 weeks follow-up. We will describe the mean (SD) and/or median (IQR) for TIR and TITR among the pooled sample of participants from both randomized arms (isCGM and CBG) achieving remission to prediabetes or remission to normoglycemia.
End of Phase 3 (30-44 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LMC Diabetes & Endocrinology Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REMIT2D isCGM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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