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

NCT05364476 | Completed

• 1 other identifier: MHREC/MOH/2022/4(1)
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type II

Keywords

digital intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in body mass index (BMI)

  16 weeks

• Change in lipid profile

  16 weeks

• Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool

  Baseline

• Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan)

  Fasting period over the 16 weeks intervention period

• Change in EQ-5D-5L score

  16 weeks

Study Arms (1)

16 weeks digital intervention with online and offline support

EXPERIMENTAL

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

Interventions

16 weeks digital intervention BEHAVIORAL

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.

Also known as: lifestyle intervention

16 weeks digital intervention with online and offline support

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EVYD Technology: lead
• Raja Isteri Pengiran Anak Saleha Hospital: collaborator

Study Sites (1)

EVYD Technology Limited

Singapore, 078994, Singapore

Location

Related Publications (1)

• 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.

  PMID: 36477014 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alice Moi Ling Yong, MBBS

  Raja Isteri Pengiran Anak Saleha Hospital (RIPAS) Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 6, 2022
• Study Start: April 11, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)