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.
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
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
Parallel
Low calorie meal replacement plan
Dietary supplementintervention 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
Behavioralintervention provided to both arms throughout study conducted as in-person session and telephone sessions
Intermittently scanned continuous glucose monitoring
Deviceintervention provided to the intervention arm only: isCGM + LCMR + DSME
capillary blood glucose monitoring
Deviceintervention provided to the control arm only: CBG + LCMR + DSME
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
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)
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
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
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
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.
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LMC Diabetes & Endocrinology Ltd.
Lead sponsor
Abbott Diabetes Care
Collaborator
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