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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 12
- 主要终点
- Percentage of participants who achieve remission at the end of phase 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
isCGM + LCMR + DSME
Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education
干预措施: Low calorie meal replacement plan (Dietary Supplement)
isCGM + LCMR + DSME
Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education
干预措施: Diabetes self management education (Behavioral)
isCGM + LCMR + DSME
Group using an intermittently scanned continuous glucose monitor and receiving low calorie meal replacement and diabetes self management education
干预措施: Intermittently scanned continuous glucose monitoring (Device)
CBG + LCMR + DSME
Group using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education
干预措施: Low calorie meal replacement plan (Dietary Supplement)
CBG + LCMR + DSME
Group using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education
干预措施: Diabetes self management education (Behavioral)
CBG + LCMR + DSME
Group using a capillary blood glucose monitor and receiving low calorie meal replacement and diabetes self management education
干预措施: capillary blood glucose monitoring (Device)
结局指标
主要结局
Percentage of participants who achieve remission at the end of phase 2
时间窗: 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
Percentage of participants who achieve remission at the end of phase 2
时间窗: 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
次要结局
- Time spent in Phase 1(from enrollment to end of phase 1 (12-24 weeks))
- Proportion of participants achieving remission at the end of phase 1(from enrollment to end of phase 1 (12-24 weeks))
- Proportion of participants achieving remission to prediabetes at the end of phase 1(from enrollment to end of phase 1 (12-24 weeks))
- Proportion of participants achieving remission to normoglycemia at the end of phase 1(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(from enrollment to end of Phase 1 (12-24 weeks))
- Adherence to low calorie meal replacement at the end of phase 1(from enrollment to end of Phase 1 (12-24 weeks))
- Percentage relapse at the end of Phase 1(from enrollment to end of Phase 1 (12-24 weeks))
- Proportion of participants achieving remission to prediabetes at the end of phase 2(from enrollment to end of phase 2 (18-30 weeks))
- Proportion of participants achieving remission to normoglycemia at the end of phase 2(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(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(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(from enrollment to end of phase 2 (18-30 weeks))
- Proportion of participants achieving remission of T2D at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Proportion of participants achieving remission to prediabetes at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Proportion of participants achieving remission to normoglycemia at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Low Calorie Meal Replacement persistence at the end of Phase 3(End of Phase 3 (30-42 weeks))
- Proportion of participants initiating/reinitiating antihyperglycemic agents at the end of phase 3(from enrollment to end of phase 3 ( 30-44 weeks))
- Follow-up and change in body weight at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Follow-up and change in BMI at the end of phase 3(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(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(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Tight Time in Range (TITR) at the end of Phase 3(enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time Below Range (TBR) at the end of Phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Change in Percent Time Below Range Level 1 at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time Below Range Level 2 at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time Above Range (TAR) at the end of Phase 3(from enrollment to end of Phase 3)
- Change in mean glucose at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Glycemic Variability at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Proportion of participants achieving remission at the end of phase 1(from enrollment to end of phase 1 (12-24 weeks))
- Proportion of participants achieving remission to prediabetes at the end of phase 1(from enrollment to end of phase 1 (12-24 weeks))
- Time spent in Phase 1(from enrollment to end of phase 1 (12-24 weeks))
- Proportion of participants achieving remission to normoglycemia at the end of phase 1(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(from enrollment to end of Phase 1 (12-24 weeks))
- Adherence to low calorie meal replacement at the end of phase 1(from enrollment to end of Phase 1 (12-24 weeks))
- Percentage relapse at the end of Phase 1(from enrollment to end of Phase 1 (12-24 weeks))
- Proportion of participants achieving remission to prediabetes at the end of phase 2(from enrollment to end of phase 2 (18-30 weeks))
- Proportion of participants achieving remission to normoglycemia at the end of phase 2(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(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(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(from enrollment to end of phase 2 (18-30 weeks))
- Proportion of participants achieving remission of T2D at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Proportion of participants achieving remission to prediabetes at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Proportion of participants achieving remission to normoglycemia at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Evaluating the change in HbA1c at the end of phase 3(from enrollment to end of phase 3 (30-42 weeks))
- Low Calorie Meal Replacement persistence at the end of Phase 3(End of Phase 3 (30-42 weeks))
- Proportion of participants initiating/reinitiating antihyperglycemic agents at the end of phase 3(from enrollment to end of phase 3 ( 30-44 weeks))
- Follow-up and change in body weight at the end of phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Follow-up and change in BMI at the end of phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Percent weight loss at the end of Phase 3(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(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(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time in Range (TIR) at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Tight Time in Range (TITR) at the end of Phase 3(enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time Below Range (TBR) at the end of Phase 3(from enrollment to end of phase 3 (30-44 weeks))
- Change in Percent Time Below Range Level 1 at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time Below Range Level 2 at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Percent Time Above Range (TAR) at the end of Phase 3(from enrollment to end of Phase 3)
- Change in mean glucose at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Glycemic Variability at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))
- Change in Glucose Management Indicator at the end of Phase 3(from enrollment to end of Phase 3 (30-44 weeks))