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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Behavioral: 16 weeks digital intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16 weeks digital intervention with online and offline support<br>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. | Behavioral: 16 weeks digital intervention<br>* Participants will be enrolled into a 16-week program which consist of an online and offline support from health coaches and dietitian. Participants will be given diet and exercise recommendations and lesson plans on a weekly basis by the health coaches, and supported by the dietitian. Participants will be required to log in their blood sugar levels, weight and steps daily using connected device, including glucometer, smart band and body fat weighing scale provided into the daily report card. They will also be required to manually record their meals and exercise daily in the daily report card provided upon enrollment into study. Reviews of log will be done on a weekly/biweekly interval by the health coaches.<br>* Other names: lifestyle intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c after 16 weeks intervention | proportion of participants with decrease in Hba1c by 0.6% through digital intervention for lifestyle modifications after 16 weeks. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI) | changes of BMI | 16 weeks | 
| Change in lipid profile | changes of lipid profile | 16 weeks | 
| Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool | 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 | Baseline | 
| Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan) | 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). | Fasting period over the 16 weeks intervention period | 
| Change in EQ-5D-5L score | 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) | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital intervention