Status:
COMPLETED
Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
Lead Sponsor:
EVYD Technology
Collaborating Sponsors:
Raja Isteri Pengiran Anak Saleha Hospital
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
20-70 years
Phase:
NA
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 inter...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05364476
Start Date
April 11 2022
End Date
April 28 2023
Last Update
July 28 2023
Active Locations (1)
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1
EVYD Technology Limited
Singapore, Singapore, 078994