Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Reduction in HbA1c from baseline following a 16-week lifestyle intervention
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Digital Therapeutics for Type 2 Diabetes Mellitus
16 weeks digital intervention with online support
This study is a single-arm, non-randomised clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention.
干预措施: 16-week digital intervention (Behavioral)
结局指标
主要结局
Reduction in HbA1c from baseline following a 16-week lifestyle intervention
时间窗: 16 weeks
The proportion of participants who achieve at least 0.6% reduction in HbA1c from baseline following a 16-week lifestyle intervention provided by DM DTx
次要结局
- Overall change in HbA1c(16 weeks)
- Change in fasting lipid profile(16 weeks)
- Change in fasting blood glucose(16 weeks)
- Change in BMI(16 weeks)
- Change in waist circumference(16 weeks)
- Participants' feedback on the use of DM DTx(16 weeks)