Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)

Официальное название

Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics

Обзор

This study is conducted to evaluate the effectiveness of Digital therapeutics (DTx) in managing patients with Type 2 Diabetes Mellitus (T2DM) by delivering digital lifestyle interventions through a national health application (BruHealth).

Подробное описание

This study is a single-arm, non-randomised clinical trial designed to evaluate the effectiveness and feasibility of an online management approach to improve glycaemic control in individuals with Type 2 Diabetes Mellitus (T2DM) through a digital lifestyle intervention (named the BALANCE Programme) over a 16-week period. The intervention leverages the Diabetes Mellitus Digital Therapeutics (DM DTx) module within the BruHealth application. Additionally, a Healthcare Professional (HCP) portal is included to facilitate ongoing monitoring and support, ensuring personalized care and real-time interactions between participants and healthcare providers.

In addition, Muslim participants are offered the option of providing information in the DM DTx module about their fasting practices during Ramadan as an opportunistic way of obtaining data on the fasting risk and fasting experience in this cohort.

Primary Objective:

The primary objective is to assess the proportion of participants who experience a reduction in HbA1c levels by at least 0.6% by the end of the 16-week intervention period.

Secondary Objectives:

1. To evaluate the overall changes in HbA1c, fasting blood glucose, Body Mass Index (BMI), waist circumference and improvements in lipid profile components (such as cholesterol and triglycerides) at week 16, compared to baseline measurements; 2. To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage; 3. to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.

Вмешательства

• Поведенческое 16-week digital intervention
  Participants will be enrolled in a 16-week programme with the aim to manage T2DM through lifestyle adjustments. Participants will be given online support by their personal health coach with additional support from a dietitian or clinician in the study if required. Each participant will receive personalised recommendations for blood glucose monitoring schedule, diet and physical activity. Participants are required to log their blood glucose, diet and physical activity in the BruHealth applicatio

Первичные конечные точки

• Reduction in HbA1c from baseline following a 16-week lifestyle intervention [Срок оценки: 16 weeks]

Вторичные конечные точки (6)

• Overall change in HbA1c [Срок оценки: 16 weeks]
• Change in fasting lipid profile [Срок оценки: 16 weeks]
• Change in fasting blood glucose [Срок оценки: 16 weeks]
• Change in BMI [Срок оценки: 16 weeks]
• Change in waist circumference [Срок оценки: 16 weeks]
• Participants' feedback on the use of DM DTx [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• Age 18 to 70 years
• Diagnosed with T2DM who are on any one or more of the following treatments:

• oral glucose lowering medication(s)
• any type of insulin treatment (up to 2 injections a day only)
• on diet control only
• GLP-1 receptor agonist established at least 6 months prior to enrolment

Критерии исключения

• Diagnosed with T2DM on more than 2 insulin injections a day
• Diagnosed with Type 1 Diabetes Mellitus (T1DM)
• Pregnant / Breast-feeding
• Recent Myocardial Infarction (MI) or Stroke / Cerebrovascular Accidents (CVA) in the past 6 months
• Heart failure
• Liver failure
• Active cancer
• Undergoing active treatment for active foot disease
• Undergoing active treatment for active diabetes-related eye disease
• CKD stage 4 and 5 (eGFR < 30ml/min)
• Hospitalisation for any reason in the past 6 months
• Advised by doctor to not participate in intense physical activity
• Physical disability and/or unable to perform Activities of Daily Living (ADL) independently
• Unable to use Youtube on mobile devices
• Unable to use BruHealth independently

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Brunei · 1 центр

• EVYD Technology — Bandar Seri Begawan

Идентификаторы

NCT: NCT06810986 · MHREC/MOH/2024/11 · BALANCE Programme

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗