An interventional study of SnapD and Linx CGM in Type2 Diabetes Mellitus, sponsored by Ramathibodi Hospital. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Treatment
Study Title: The Effectiveness of an AI-powered Thai food analysis (SnapD) and Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes and Overweight or Obesity: A Randomized Controlled Pilot Study Rationale: Effective dietary management is the cornerstone of treating Type 2 Diabetes (T2DM) and obesity. However, traditional manual food logging is often inaccurate and burdensome. While digital tools and Continuous Glucose Monitoring (CGM) have shown promise internationally, there is a lack of validated AI-powered tools specifically designed for Thai cuisine. This study introduces SnapD, an AI-powered platform (utilizing Gemini 2.5 Flash) designed to recognize Thai food, estimate nutritional values, and integrate with CGM data to provide personalized feedback.
The primary goal of this pilot study is to evaluate the efficacy of the SnapD application, both as a standalone tool and in combination with CGM, compared to Standard of Care in improving glycemic control (HbA1c) over 8 weeks. Additionally, the study aims to assess the feasibility, participant adherence, and safety of these digital interventions to inform a future, fully powered randomized controlled trial.
Study Design: This is an 8-week, randomized, open-label, parallel-group, superiority pilot study with a 1:1:1 allocation ratio. A total of 45 participants will be enrolled and assigned to one of three arms:
End-of-Study (Week 8): Assessment of HbA1c, body weight, waist circumference, lipid profile, and patient-reported outcomes (self-care activities and user satisfaction) Primary Outcome: Mean change in HbA1c from baseline to 8 weeks Secondary Outcomes: Changes in Fasting Plasma Glucose (FPG), body weight, waist circumference, and lipid profiles, Diabetes self-management scores (SDSCA questionnaire), User satisfaction with the SnapD application, Incidence of adverse events (hypoglycemia/hyperglycemia).
Significance: This study will provide preliminary evidence on the synergistic benefits of AI-driven nutritional feedback and CGM in a Thai-specific context, supporting the development of scalable, culturally adapted digital health technologies for diabetes management.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 45 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of the AI-powered SnapD application to log meals (at least 2 times/day) combined with a 15-day real-time CGM session. Participants also receive one session of Diabetes Self-Management Education and Support (DSMES).
Device: SnapD · Device: Linx CGM · Other: Diabetes Self-Management Education (DSMES)
Use of the SnapD application as a standalone digital food diary to log meals (at least 2 times/day) throughout the 8-week study. Participants receive one session of DSMES.
Device: SnapD · Other: Diabetes Self-Management Education (DSMES)
Standard of care including one session of DSMES (20-30 minutes) and self-directed behavioral changes.
Other: Diabetes Self-Management Education (DSMES)
SnapD, developed by the Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, is a Progressive Web App. It is built using React 18.3.1, TypeScript, and Vite for responsive performance on both mobile and desktop platforms. The application utilizes Supabase for database management, which operates on a PostgreSQL backend.
The Linx CGM system, manufactured by Connect Diagnostics, is a real-time device that measures glucose concentrations in the interstitial fluid. It is an all-in-one device, integrating the glucose sensor, applicator, and transmitter into a single unit. The device has a diameter not exceeding 22 mm and a weight not exceeding 2.2 g. The sensor has a maximum operational life (wear time) of 15 days. It demonstrates a Mean Absolute Relative Difference (MARD) not exceeding 8.67%, which meets the standard accuracy requirement of \<10%. This device was registered as a medical device by the Thai Food and Drug Administration (Thai FDA), Ministry of Public Health, in January 2025, for the indication of management of diabetes in adults age 18 and older (as shown in the attached document) .
Participants will receive 1 single session of DSMES, 20-30 minutes/session. This single session will be delivered at the baseline visit only. All personnel providing DSMES are Certified Dietitians (CD) and/or have passed the Certified Diabetes Educator (Thai CDE) examination
To evaluate the efficacy of two intervention arms on glycemic control
HbA1c level(%)
Time frame: baseline, 8 weeks
To assess changes in other glycemic parameter
Fasting plasma glucose(mg/dL)
Time frame: baseline, 8 weeks
To assess changes in anthropometric measurements
Body Mass Index(Kg/m2)
Time frame: baseline, 8 weeks
To evaluate changes in metabolic parameters
• change in systolic and diastolic blood pressure (mmHg)
Time frame: baseline, 8 weeks
To evaluate changes in diabetic self-management activities via questionnaire
A modified version of the SDSCA tool, developed by Rattanaporn Jeerawattana, encompassing domains of diet, exercise, self-monitoring, foot care, and medication. The total score ranges from 0 to 133, where higher scores indicate better diabetes self-care activities.
Time frame: Baseline, 8 weeks
• To evaluate user satisfaction scores for the SnapD application
Name of the questionnaire is User satisfaction with the SnapD and CGM application. It was an a self-developed questionnaire validated by experts. The total score ranges from 7 to 35, where higher scores indicate better user satisfaction.
Time frame: 8 weeks
• To assess adverse events about glycemic control
• Incidence of hypoglycemia and/or hyperglycemia
Time frame: up to 8 weeks
To assess changes in anthropometric measurements
change in waist circumference(cm)
Time frame: baseline, 8 weeks
Change in metabolic parameters
change in lipid profile including serum Total Cholesterol, Triglyceride-Cholesterol, HDL-Cholesterol, LDL-Cholesterol
Time frame: baseline, 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 7 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Ramathibodi Hospital