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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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.
EVYD Technology Limited
Singapore, Singapore
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.
Time frame: 16 weeks
Change in body mass index (BMI)
changes of BMI
Time frame: 16 weeks
Change in lipid profile
changes of lipid profile
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 16 weeks
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