Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD)- a Clinical Non-randomised Pilot Trial in Brunei Darussalam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change of HbA1c after 16 weeks intervention
研究概览
简要总结
The study is conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled Type 2 Diabetes Mellitus (T2DM), to explore the intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.
详细描述
The study is a single-arm, non-randomized clinical trial conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled T2DM, to explore the 16 weeks intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.
Primary objective is to study the proportion of participants with decrease in Hba1c by 0.6% by providing digital based lifestyle modifications. Secondary objectives include to 1) estimate the change in Hba1c, body mass index (BMI) and improvement in lipid profile components at week 16 compared with baseline readings; 2) to evaluate of the use of the Ramadan Risk Score (IDF-DAR Risk Stratification Scoring Tool); 3) to evaluate the rate of fasting and diabetes complications (hyperglycaemia / hypoglycaemia) amongst Muslims with T2DM during Ramadan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants diagnosed with T2DM;
- •HbA1c 7% and above in the latest blood test valid up to 12months prior to recruitment;
- •age range between 20-70 years old;
- •BMI between 23-50kg/m2
排除标准
- •Pregnant / Breast feeding participants
- •Participants on insulin therapy or non-insulin injectable medication
- •History of diabetes crisis (hyper or hypoglycaemia) in the past 6 months
- •Blood pressure ≥ 160/100 mmHg
- •Recurrent history of acute pancreatitis
- •Decompensated liver cirrhosis
- •eGFR <60ml/min/1.73m2
- •History of acute myocardial infarction/acute coronary syndrome(within the past 1 year), arrhythmias, heart failure (NY Class II -IV)
- •Proliferative diabetic retinopathy-Foot ulcer, gangrene
- •Deep vein thrombosis of lower limbs(within the past 12 months)
- •Intermittent claudication -History of cerebral haemorrhage or acute cerebral infarction (within the past 12 months)
- •History of active cancer
- •Post-transplant/perioperative participants(defined as planned for operation for the next 6 months)
- •History of hypo or hyperthyroidism, including subclinical states
- •Musculoskeletal injuries resulting in difficulty to perform physical activities
- •Failure to provide consent
- •Unable to perform activities of daily livings (ADLs)
- •Unable to use WhatsApp and YouTube via mobile devices, e.g. phone or tablet.
结局指标
主要结局
Change of HbA1c after 16 weeks intervention
时间窗: 16 weeks
proportion of participants with decrease in Hba1c by 0.6% through digital intervention for lifestyle modifications after 16 weeks.
次要结局
- Change in body mass index (BMI)(16 weeks)
- Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan)(Fasting period over the 16 weeks intervention period)
- Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool(Baseline)
- Change in EQ-5D-5L score(16 weeks)
- Change in lipid profile(16 weeks)