SnapDandCGMinType2Diabetes (SnapD in T2DM)

April 9, 2026 updated by: Supasuta Wongdama, Ramathibodi Hospital

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.

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:

  1. Intervention Arm 1: SnapD application + Real-time CGM + Diabetes Self-Management Education and Support (DSMES)
  2. Intervention Arm 2: SnapD application standalone + DSMES
  3. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10400
        • Recruiting
        • Department of Medicine, Ramathibodi Hospital,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 65 years, male or female at birth
  2. Diagnosed with type 2 Diabetes Mellitus with overweight or obesity (BMI>23 kg/m²)
  3. Hemoglobin A1c (HbA1c) 6.5-9% measured within 3 months prior to the screening date
  4. Willing to maintain their current antidiabetic medication regimen without dose adjustment for the entire 8-week study duration
  5. Must possess an internet-enabled devices e.g. smartphone, tablet compatible with the SnapD application
  6. Able and willing to adhere intervention, including using snapD and CGM

Exclusion Criteria:

  1. Currently pregnant, plan pregnancy or breastfeeding during the 8-week study period
  2. Current participation in another interventional clinical trial
  3. Current use of insulin or incretin-based therapies (e.g., GLP-1 Receptor Agonists, GIP/GLP-1 Receptor Agonists)
  4. 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
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SnapD + CGM
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
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.
Device: Linx CGM

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) .

Other: Diabetes Self-Management Education (DSMES)

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
Experimental: SnapD Application only
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
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.
Other: Diabetes Self-Management Education (DSMES)

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
Placebo Comparator: Standard Care (DSMES)
Standard of care including one session of DSMES (20-30 minutes) and self-directed behavioral changes.
Other: Diabetes Self-Management Education (DSMES)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of two intervention arms on glycemic control
Time Frame: baseline, 8 weeks
HbA1c level(%)
baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess changes in other glycemic parameter
Time Frame: baseline, 8 weeks
Fasting plasma glucose(mg/dL)
baseline, 8 weeks
To assess changes in anthropometric measurements
Time Frame: baseline, 8 weeks
Body Mass Index(Kg/m2)
baseline, 8 weeks
To evaluate changes in metabolic parameters
Time Frame: baseline, 8 weeks
• change in systolic and diastolic blood pressure (mmHg)
baseline, 8 weeks
To evaluate changes in diabetic self-management activities via questionnaire
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
• To evaluate user satisfaction scores for the SnapD application
Time Frame: 8 weeks
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.
8 weeks
• To assess adverse events about glycemic control
Time Frame: up to 8 weeks
• Incidence of hypoglycemia and/or hyperglycemia
up to 8 weeks
To assess changes in anthropometric measurements
Time Frame: baseline, 8 weeks
change in waist circumference(cm)
baseline, 8 weeks
Change in metabolic parameters
Time Frame: baseline, 8 weeks
change in lipid profile including serum Total Cholesterol, Triglyceride-Cholesterol, HDL-Cholesterol, LDL-Cholesterol
baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Supasuta Wongdama, Ramathibodi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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