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NCT Number: 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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LMC Brampton, Brampton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Diabetes Self Management Education

Behavioral

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

Intermittently scanned continuous glucose monitoring

Device

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

capillary blood glucose monitoring

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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).

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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)

  14. 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)

  15. 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)

  16. 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

  17. 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).

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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.

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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.

  31. 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.

  32. 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)

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Data Science

CONTACT

[email protected]

14166452929

Research Assistant, Data Science

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Collaborators

  • Abbott Diabetes Care

Registry information

Official study 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

Acronym: REMIT2D isCGM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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