Development and Exploration of the Effectiveness and Feasibility of a Digital INtervention for Type 2 Diabetes MEllitus

Overview

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 Title of Study: “Development and Exploration of the Effectiveness and Feasibility of a Digital INtervention for Type 2 Diabetes MEllitus (DEFINE): a Clinical Non-randomised Pilot Trial in Brunei Darussalam”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2022

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.

Interventions

  • Behavioral: 16 weeks digital intervention
    • 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.

Arms, Groups and Cohorts

  • Experimental: 16 weeks digital intervention with online and offline support
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change of HbA1c after 16 weeks intervention
    • Time Frame: 16 weeks
    • proportion of participants with decrease in Hba1c by 0.6% through digital intervention for lifestyle modifications after 16 weeks.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • participants diagnosed with T2DM; – diagnosed duration of T2DM of less than 5 years; – HbA1c between 8% -10% in the latest blood test valid up to 12months prior to recruitment; – age range between 20-70 years old; – BMI between 25-40kg/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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EVYD Technology
  • Collaborator
    • Raja Isteri Pengiran Anak Saleha Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alice Moi Ling Yong, MBBS, Principal Investigator, Raja Isteri Pengiran Anak Saleha Hospital (RIPAS) Hospital
  • Overall Contact(s)
    • Hiu Nam Chan, Dietetics, +65 92300660, candy.chan@evydtech.com

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