Type 2 DiabetesREMIT2D isCGMNCT07157384
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
A study testing Low calorie meal replacement plan, Diabetes self management education and Intermittently scanned continuous glucose monitoring in people with Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Low calorie meal replacement plan, Diabetes self management education and Intermittently scanned continuous glucose monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Research Assistant, Data Science contact
6 sites in 1 country
Canada6 sites
LMC Brampton
Brampton, Ontario
Manager, Data Science, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
LMC Etobicoke
Etobicoke, Ontario
Manager, Data Science, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
LMC Oakville
Oakville, Ontario
Manager, Data Science, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
LMC Ottawa
Ottawa, Ontario
Manager, Data Science, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
LMC Bayview
Toronto, Ontario, M4G 3E8
Manager, Data Science, 14166452929, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
LMC Vaughan
Vaughan, Ontario
Manager, Data Science, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
About this study
Official 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
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).
Read more
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
- Being tested
- Low calorie meal replacement plan, Diabetes self management education, Intermittently scanned continuous glucose monitoring, capillary blood glucose monitoring
- Keywords
- low-calorie meal replacement, remission, intermittently scanned continuous glucose monitoring, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low calorie meal replacement planDietary 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 educationBehavioural
intervention provided to both arms throughout study conducted as in-person session and telephone sessions
Intermittently scanned continuous glucose monitoringDevice
intervention provided to the intervention arm only: isCGM + LCMR + DSME
capillary blood glucose monitoringDevice
intervention provided to the control arm only: CBG + LCMR + DSME
| Study group | Role | What they receive |
|---|---|---|
| isCGM + LCMR + DSME | Experimental | Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education Receives: 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 Receives: Dietary Supplement: Low calorie meal replacement plan; Behavioral: Diabetes self management education; Device: capillary blood glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to end of phase 2 (18-30 weeks)
Secondary outcomes (32)
Proportion of participants achieving remission at the end of phase 1
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)
Measured: from enrollment to end of phase 1 (12-24 weeks)
Proportion of participants achieving remission to prediabetes at the end of phase 1
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
Measured: from enrollment to end of phase 1 (12-24 weeks)
Proportion of participants achieving remission to normoglycemia at the end of phase 1
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
Measured: 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
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
Measured: from enrollment to end of Phase 1 (12-24 weeks)
Adherence to low calorie meal replacement at the end of phase 1
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.
Measured: from enrollment to end of Phase 1 (12-24 weeks)
Percentage relapse at the end of Phase 1
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).
Measured: from enrollment to end of Phase 1 (12-24 weeks)
Time spent in Phase 1
Comparing the time spent in Phase 1 (12-24 weeks) between intervention and control group. Time spent will be measured in weeks
Measured: from enrollment to end of phase 1 (12-24 weeks)
Proportion of participants achieving remission to prediabetes at the end of phase 2
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
Measured: from enrollment to end of phase 2 (18-30 weeks)
Proportion of participants achieving remission to normoglycemia at the end of phase 2
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: from enrollment to end of phase 2 (18-30 weeks)
Proportion of participants achieving remission of T2D at the end of phase 3
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)
Measured: from enrollment to end of phase 3 (30-44 weeks)
Proportion of participants achieving remission to prediabetes at the end of phase 3
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)
Measured: from enrollment to end of phase 3 (30-44 weeks)
Proportion of participants achieving remission to normoglycemia at the end of phase 3
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)
Measured: from enrollment to end of phase 3 (30-44 weeks)
Evaluating the change in HbA1c at the end of phase 3
Evaluating the change in HbA1c (%) at 30-44 weeks follow-up between intervention and control group
Measured: from enrollment to end of phase 3 (30-42 weeks)
Low Calorie Meal Replacement persistence at the end of Phase 3
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).
Measured: End of Phase 3 (30-42 weeks)
Proportion of participants initiating/reinitiating antihyperglycemic agents at the end of phase 3
Evaluating the proportion of participants initiating/reinitiating antihyperglycemic agents at the end of phase 3 (30-44 weeks) between the intervention and control group.
Measured: from enrollment to end of phase 3 ( 30-44 weeks)
Follow-up and change in body weight at the end of phase 3
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
Measured: from enrollment to end of phase 3 (30-44 weeks)
Follow-up and change in BMI at the end of phase 3
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
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Percent weight loss at the end of Phase 3
Evaluating the percent weight loss at the end of Phase 3 (30-44 weeks) between the intervention and control group
Measured: 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
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.
Measured: 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
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
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time in Range (TIR) at the end of Phase 3
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
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Tight Time in Range (TITR) at the end of Phase 3
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
Measured: enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time Below Range (TBR) at the end of Phase 3
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
Measured: from enrollment to end of phase 3 (30-44 weeks)
Change in Percent Time Below Range Level 1 at the end of Phase 3
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
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time Below Range Level 2 at the end of Phase 3
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
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Change in Percent Time Above Range (TAR) at the 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
Measured: from enrollment to end of Phase 3
Change in mean glucose at the end of Phase 3
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.
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Change in Glycemic Variability at the end of Phase 3
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.
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Change in Glucose Management Indicator at the end of Phase 3
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)
Measured: from enrollment to end of Phase 3 (30-44 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157384
- Sponsor's protocol ID
- REMIT2D isCGM
- Acronym
- REMIT2D isCGM
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07157384
- Acronym / sponsor ID
- REMIT2D isCGM / REMIT2D isCGM
- Conditions
- Type 2 Diabetes
- Keywords
- low-calorie meal replacement, remission, intermittently scanned continuous glucose monitoring, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isCGM + LCMR + DSME | Experimental | Dietary Supplement: Low calorie meal replacement plan, Behavioral: Diabetes self management education, Device: Intermittently scanned continuous glucose monitoringGroup using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education |
| CBG + LCMR + DSME | Active comparator | Dietary Supplement: Low calorie meal replacement plan, Behavioral: Diabetes self management education, Device: capillary blood glucose monitoringGroup using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low calorie meal replacement planintervention provided to both arms in 2 out of the 3 study phases: Phase 1 (total dietary replacement) and Phase 2 (food re-introduction) | Dietary supplement | CBG + LCMR + DSME, isCGM + LCMR + DSME |
| Diabetes self management educationintervention provided to both arms throughout study conducted as in-person session and telephone sessions | Behavioural | CBG + LCMR + DSME, isCGM + LCMR + DSME |
| Intermittently scanned continuous glucose monitoringintervention provided to the intervention arm only: isCGM + LCMR + DSME | Device | isCGM + LCMR + DSME |
| capillary blood glucose monitoringintervention provided to the control arm only: CBG + LCMR + DSME | Device | CBG + LCMR + DSME |
Primary outcome
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
32 secondary outcomes
Proportion of participants achieving remission at the end of phase 1
Time frame: 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)
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)
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)
Adherence to low calorie meal replacement at the end of phase 1
Time frame: 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)
Time spent in Phase 1
Time frame: 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)
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)
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)
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)
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)
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)
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)
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 change in HbA1c at the end of phase 3
Time frame: 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)
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)
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)
Follow-up and change in BMI at the end of phase 3
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
Change in Percent Time Above Range (TAR) at the end of Phase 3
Time frame: 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)
Change in Glycemic Variability at the end of Phase 3
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Research Assistant, Data Science contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low calorie meal replacement plan, Diabetes self management education and Intermittently scanned continuous glucose monitoring in people with Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager, Data Science (14166452929, lisa.chu@lmc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who achieve remission at the end of phase 2 (time frame: from enrollment to end of phase 2 (18-30 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.