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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetes Mellitus, Type II
- 发起方
- EVYD Technology
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change of HbA1c after 16 weeks intervention
- 状态
- 已完成
- 最后更新
- 2年前
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.
研究者
入排标准
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)
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)