Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type II
- Interventions
- Behavioral: 16 weeks digital intervention
- Registration Number
- NCT05364476
- Lead Sponsor
- EVYD Technology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 16 weeks digital intervention with online and offline support 16 weeks digital intervention This study is a single-arm, non-randomized 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.
- Primary Outcome Measures
Name Time Method Change of HbA1c after 16 weeks intervention 16 weeks proportion of participants with decrease in Hba1c by 0.6% through digital intervention for lifestyle modifications after 16 weeks.
- Secondary Outcome Measures
Name Time Method Change in body mass index (BMI) 16 weeks changes of BMI
Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan) Fasting period over the 16 weeks intervention period evaluate the number of Muslim participant experiences with diabetes complications of hypoglycaemia (defined as capillary blood glucose of \< 4mmol/L) and/or hyper-glycaemia (defined as capillary blood glucose of \> 16.6mmo/L).
Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool Baseline Risk of fasting based on calculated risk score by using IDF-DAR Risk Stratification Scoring tool at baseline for Muslim participant who intend to fast
Change in EQ-5D-5L score 16 weeks changes of EQ-5D-5L score of each dimensions i.e. Mobility, Self-care, Usual activities, pain/discomfort and anxiety/ depression, and self-rating of health from a scale 0 to 100 (0 means the worst and 100 means the best health) to assess participants' health related quality of life (QOL)
Change in lipid profile 16 weeks changes of lipid profile
Trial Locations
- Locations (1)
EVYD Technology Limited
🇸🇬Singapore, Singapore