Clinical trial NCT05364476: Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type II
Keywords: digital intervention
Lead sponsor: EVYD Technology
Sponsor class: INDUSTRY
Collaborators: name: Raja Isteri Pengiran Anak Saleha Hospital
First posted: 2022-05-06
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of HbA1c after 16 weeks intervention
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in body mass index (BMI)
timeFrame: 16 weeks
measure: Change in lipid profile
timeFrame: 16 weeks
measure: Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool
timeFrame: Baseline
measure: Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan)
timeFrame: Fasting period over the 16 weeks intervention period
measure: Change in EQ-5D-5L score
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: EVYD Technology Limited
Study officials:
affiliation: Raja Isteri Pengiran Anak Saleha Hospital (RIPAS) Hospital
name: Alice Moi Ling Yong, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan HN, Lim HS, Chong PL, Yung CK, Abd Mulok M, Wei Y, Yong AML. Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam. JMIR Res Protoc. 2022 Dec 7;11(12):e43208. doi: 10.2196/43208.