Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott Diabetes Care | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isCGM + LCMR + DSME | Experimental | Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education |
|
| CBG + LCMR + DSME | Active Comparator | Group using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from enrollment to end of phase 2 (18-30 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating isCGM metrics at the end of phase 3 between isCGM+ LCMR+ DSME and CBG+ LMCR+ DSME | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager, Data Science | Contact | 14166452929 | lisa.chu@lmc.ca | |
| Research Assistant, Data Science | Contact | giovana.romero@lmc.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Brampton | Brampton | Ontario | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 | 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 | 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 | 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. | 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). | 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 | 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 | 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 | 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. | 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. | 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. | 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) | 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) | 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) | 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 | 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). | 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. | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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) | from enrollment to end of Phase 3 (30-44 weeks) |
| End of Phase 3 (30-44 weeks) |
| LMC Etobicoke | Etobicoke | Ontario | Canada |
|
| LMC Oakville | Oakville | Ontario | Canada |
|
| LMC Ottawa | Ottawa | Ontario | Canada |
|
| LMC Bayview | Toronto | Ontario | M4G 3E8 | Canada |
|
| LMC Vaughan | Vaughan | Ontario | Canada |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided