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

Diabetes Mellitus, Type II Clinical Trial

— DEsireD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364476
• Other study ID #: MHREC/MOH/2022/4(1)
• Status: Completed
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: July 2023
• Source: EVYD Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

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.

Locations

Country	Name	City	State
Singapore	EVYD Technology Limited	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
EVYD Technology	Raja Isteri Pengiran Anak Saleha Hospital

Country where clinical trial is conducted

Singapore, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in body mass index (BMI)	changes of BMI	16 weeks
Secondary	Change in lipid profile	changes of lipid profile	16 weeks
Secondary	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
Secondary	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
Secondary	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

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