Type2 Diabetes MellitusSnapDinT2DMNCT07533604
SnapDandCGMinType2DM
A study testing SnapD, Linx CGM and Diabetes Self-Management Education (DSMES) in people with Type2 Diabetes Mellitus, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- SnapD, Linx CGM and Diabetes Self-Management Education (DSMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jan 2026to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years, male or female at birth
- Diagnosed with type 2 Diabetes Mellitus with overweight or obesity (BMI>23 kg/m²)
- Hemoglobin A1c (HbA1c) 6.5-9% measured within 3 months prior to the screening date
- Willing to maintain their current antidiabetic medication regimen without dose adjustment for the entire 8-week study duration
- Must possess an internet-enabled devices e.g. smartphone, tablet compatible with the SnapD application
- Able and willing to adhere intervention, including using snapD and CGM
Who cannot join
- Currently pregnant, plan pregnancy or breastfeeding during the 8-week study period
- Current participation in another interventional clinical trial
- Current use of insulin or incretin-based therapies (e.g., GLP-1 Receptor Agonists, GIP/GLP-1 Receptor Agonists)
- Presence of severe hearing or visual impairment that, in the investigator's judgment, would preclude the participant from safely and effectively using the SnapD application or the CGM device
- known contraindication to CGM usage e.g., a history of severe hypersensitivity to the device's materials or adhesive, planing to go on CT-contrasted imaging etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Department of Medicine, Ramathibodi Hospital,
Bangkok, Bangkok, 10400
Supasuta Wongdama, Doctor of Medicine, +6690-575-4190, supasuta.won@gmail.com
About this study
Official 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
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.
Read more
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:
- Intervention Arm 1: SnapD application + Real-time CGM + Diabetes Self-Management Education and Support (DSMES)
- Intervention Arm 2: SnapD application standalone + DSMES
- Control Arm: DSMES alone Inclusion Criteria Highlights: Adults (18-65 years) diagnosed with T2D with BMI > 23 kg/m² (overweight/obesity) with HbA1c between 6.5% and 9.0% with Must possess a compatible smartphone/tablet Procedures: Baseline (Visit 1): All participants receive 20-30 minutes of DSMES. Intervention groups receive training on SnapD. Arm 1 receives a 15-day CGM sensor.During Study: Intervention arms log meals via SnapD (at least twice daily). Nutritionists conduct bi-weekly follow-up calls to address technical issues and provide support.
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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- SnapD, Linx CGM, Diabetes Self-Management Education (DSMES)
- Keywords
- AI-powered Thai food analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnapDDevice
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.
Linx CGMDevice
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) .
Diabetes Self-Management Education (DSMES)Other
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
| Study group | Role | What they receive |
|---|---|---|
| SnapD + CGM | Experimental | 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). Receives: Device: SnapD; Device: Linx CGM; Other: Diabetes Self-Management Education (DSMES) |
| SnapD Application only | Experimental | 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. Receives: Device: SnapD; Other: Diabetes Self-Management Education (DSMES) |
| Standard Care (DSMES) | Placebo comparator | Standard of care including one session of DSMES (20-30 minutes) and self-directed behavioral changes. Receives: Other: Diabetes Self-Management Education (DSMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of two intervention arms on glycemic control
HbA1c level(%)
Measured: baseline, 8 weeks
Secondary outcomes (8)
To assess changes in other glycemic parameter
Fasting plasma glucose(mg/dL)
Measured: baseline, 8 weeks
To assess changes in anthropometric measurements
Body Mass Index(Kg/m2)
Measured: baseline, 8 weeks
To evaluate changes in metabolic parameters
- change in systolic and diastolic blood pressure (mmHg)
Measured: 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.
Measured: 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.
Measured: 8 weeks
• To assess adverse events about glycemic control
- Incidence of hypoglycemia and/or hyperglycemia
Measured: up to 8 weeks
To assess changes in anthropometric measurements
change in waist circumference(cm)
Measured: baseline, 8 weeks
Change in metabolic parameters
change in lipid profile including serum Total Cholesterol, Triglyceride-Cholesterol, HDL-Cholesterol, LDL-Cholesterol
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Jan 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open-label, parallel-group, superiority pilot study designed with a 1:1:1 allocation ratio. The study compares two digital intervention arms against a standard of care control group over an 8-week period. Arm 1 (SnapD + CGM): Participants use the SnapD AI-powered application for food logging combined with a 15-day session of real-time Continuous Glucose Monitoring (CGM). Arm 2 (SnapD only): Participants use the SnapD application as a standalone digital food diary. Control Arm: Participants receive standard Diabetes Self-Management Education and Support (DSMES) only. The randomization uses a permuted variable block size design to ensure balanced allocation. Allocation concealment is maintained using sequentially numbered, opaque, sealed envelopes. The study aims to evaluate the feasibility and preliminary efficacy of these tools in patients with type 2 diabetes and overweight or obesity.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supasuta Wongdama, Ramathibodi Hospital
- Investigators
- Supasuta Wongdama, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533604
- Sponsor's protocol ID
- 7930
- Acronym
- SnapDinT2DM
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No