Prediabetes Obesity Type 2 diabetes mellitus (prevention) Prediabetic State Obesity Blood Glucose Self-Monitoring Continuous Glucose Monitoring Diabetes Mellitus, Type 2 Telemedicine Counseling Healthy Lifestyle Randomized Controlled Trial
Conditions
Interventions
Standardised online DPP-based lifestyle programme plus real-time CGM worn at weeks 4, 8 and 13, with alerts and weekly video coaching (CGM review, feedback, outreach, goal-setting).,Same online DPP-ba
Experimental Behavioral,Active Comparator Behavioral
Real time CGM with intensive coaching (rtCGM + Intensive Coaching),CGM with standard support
Sponsors
Nawinda Vanichakulthada, MD (investigator-sponsor)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults aged 30 to 65 years Prediabetes documented within the past 3 months by ADA criteria (HbA1c 5.7 to 6.4%, or fasting plasma glucose 100 to 125 mg/dL, or 2-hour OGTT glucose 140 to 199 mg/dL) Obesity: BMI 25 kg/m2 or higher for Asian population, or 30 kg/m2 or higher for non-Asian population, up to 40 kg/m2 Smartphone ownership (iOS 14 or later, or Android 8 or later) with reliable internet access Access to a Zoom-capable device (computer, tablet, or smartphone) Valid mailing address in Thailand for device shipment Able to read and understand Thai or English Willing and able to provide electronic informed consent
Exclusion criteria
Exclusion criteria: Diagnosis of type 1 or type 2 diabetes mellitus Current use of glucose-lowering medications (metformin, GLP-1 receptor agonists, SGLT2 inhibitors, etc.) Use of systemic corticosteroids within the past 3 months Pregnancy, breastfeeding, or planning pregnancy during the study period History of bariatric surgery Active malignancy or cancer treatment within the past 5 years (except non-melanoma skin cancer) Known chronic kidney disease (self-reported) Known severe hepatic impairment (self-reported) Psychiatric condition that would impair participation Known allergy to sensor adhesive materials Skin conditions precluding sensor wear Participation in another interventional clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose Management Indicator (GMI) Baseline and week 13 (endpoint) Change in Glucose Management Indicator (GMI) derived from CGM, calculated as 3.31 plus 0.02392 times mean glucose in mg/dL | — |
Secondary
| Measure | Time frame |
|---|---|
| Time in Range (TIR) Weeks 4, 8, 13 (Arm A); week 13 (Arm B) Percent time glucose 70 to 140 mg/dL from CGM,Glycaemic variability Weeks 4, 8, 13 (Arm A); week 13 (Arm B) Coefficient of variation (CV%) and MAGE from CGM,Waist circumference Every 4 weeks Self-reported waist circumference (cm),Body weight Weekly, weeks 1 to 16 Self-reported weight (kg) and percent change from baseline,Physical activity Baseline, mid-intervention, close-out IPAQ-SF (MET-minutes per week),Quality of life Baseline and close-out DDS-2 score | — |
Countries
Thailand
Contacts
Public ContactNawinda Vanichakulthada
Ubon Ratchathani University
Outcome results
None listed