Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD)

EVYD Technology

Status: Completed

Conditions: Diabetes Mellitus, Type II

Treatments: Behavioral: 16 weeks digital intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05364476

MHREC/MOH/2022/4(1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

16 weeks digital intervention with online and offline support

Experimental group

Description:

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.

Treatment:

Behavioral: 16 weeks digital intervention