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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Low calorie meal replacement plan
  intervention provided to both arms in 2 out of the 3 study phases: Phase 1 (total dietary replacement) and Phase 2 (food re-introduction)
• Поведенческое Diabetes self management education
  intervention provided to both arms throughout study conducted as in-person session and telephone sessions
• Устройство Intermittently scanned continuous glucose monitoring
  intervention provided to the intervention arm only: isCGM + LCMR + DSME
• Устройство capillary blood glucose monitoring
  intervention provided to the control arm only: CBG + LCMR + DSME

Первичные конечные точки

• Percentage of participants who achieve remission at the end of phase 2 [Срок оценки: from enrollment to end of phase 2 (18-30 weeks)]

Вторичные конечные точки (12)

• Proportion of participants achieving remission at the end of phase 1 [Срок оценки: from enrollment to end of phase 1 (12-24 weeks)]
• Proportion of participants achieving remission to prediabetes at the end of phase 1 [Срок оценки: from enrollment to end of phase 1 (12-24 weeks)]
• Proportion of participants achieving remission to normoglycemia at the end of phase 1 [Срок оценки: 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 [Срок оценки: from enrollment to end of Phase 1 (12-24 weeks)]
• Adherence to low calorie meal replacement at the end of phase 1 [Срок оценки: from enrollment to end of Phase 1 (12-24 weeks)]
• Percentage relapse at the end of Phase 1 [Срок оценки: from enrollment to end of Phase 1 (12-24 weeks)]
• Time spent in Phase 1 [Срок оценки: from enrollment to end of phase 1 (12-24 weeks)]
• Proportion of participants achieving remission to prediabetes at the end of phase 2 [Срок оценки: from enrollment to end of phase 2 (18-30 weeks)]
• Proportion of participants achieving remission to normoglycemia at the end of phase 2 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: from enrollment to end of phase 2 (18-30 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 6 центров

• LMC Brampton — Brampton
• LMC Etobicoke — Etobicoke
• LMC Oakville — Oakville
• LMC Ottawa — Ottawa
• LMC Bayview — Toronto
• LMC Vaughan — Vaughan

Идентификаторы

NCT: NCT07157384 · REMIT2D isCGM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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