An Active Health-Based Comprehensive Study on Diabetes Management

Percentage of glucose readings within 3.9-10 mmol/L measured by CGM

mean glucose, SD, CV, TAR (>10 mmol/L), TBR (<3.9 and <3.0 mmol/L), daytime/nighttime TIR, MAGE, MODD, AUC, etc.

Using DDS, DSCS, Self-Efficacy, WHO-5 scales, etc.

Evaluation in X Life group only. User experience will be assessed using a validated questionnaire covering usability, usefulness, satisfaction, and acceptability. Each item is rated on a 5-point Likert scale. Higher scores indicate better user experience.

Number of participants with CGM-recorded or symptomatic hypoglycemia (<3.9 mmol/L). Number of participants experiencing any AE/SAE.

Plasma glucose at 0, 60, and 120 minutes during OGTT.

Serum insulin at 0, 60, and 120 minutes during OGTT.

Serum C-peptide at 0, 60, and 120 minutes during OGTT.

Body weight (kg) measured using digital scale.

Calculated as weight (kg) / height (m²).

Measured at the midpoint between the lowest rib and iliac crest.

Hip circumference measured at the widest part of the buttocks using a non-stretchable tape.

Mid-thigh circumference measured at the midpoint between the inguinal crease and the proximal border of the patella.

Average of two seated measurements.

Average of two seated measurements.

Measured by automated device after 5 minutes rest.

Total cholesterol, LDL-C, HDL-C, and triglycerides.

ALT, AST, GGT, etc.

Serum creatinine, eGFR, etc.

C-reactive protein

Psychological and behavioral outcomes will be assessed using multiple validated questionnaires. Each scale will be reported and analyzed separately: Diabetes Distress Scale (DDS): 17 items, scored 1-6; higher scores indicate greater distress; General Self-Efficacy Scale (GSES): 10 items, scored 1-4, total 10-40; higher scores indicate stronger self-efficacy; WHO-5 Well-Being Index: 5 items, raw score 0-25 transformed to 0-100; higher scores indicate better well-being; Summary of Diabetes Self-Care Activities (SDSCA): Items scored 0-7 days per week; higher scores indicate better diabetes self-management behaviors.