NCT07633171 · Johns Hopkins University
Multimodal Glucose Prediction in Type 2 Diabetes
What this study is about
The primary objective of this research, funded by Samsung Strategic Alliance for Research and Technology, is to develop multi-modal foundation models that integrate Continuous Glucose Monitoring (CGM) data with patient behavior data (food intake, medication, and physical activity) to improve real-time glucose prediction and personalized diabetes management for patients with Type 2 diabetes (T2D), delivered via mobile apps and digital health tools.
View original scientific description
The primary objective of this research, funded by Samsung Strategic Alliance for Research and Technology, is to develop multi-modal foundation models that integrate Continuous Glucose Monitoring (CGM) data with patient behavior data (food intake, medication, and physical activity) to improve real-time glucose prediction and personalized diabetes management for patients with Type 2 diabetes (T2D), delivered via mobile apps and digital health tools.
Interventions
DEVICE
Digital Health Data Collection System
Participants will use a digital health data collection system that includes the Welldoc app, a Samsung smartwatch, and the participant's existing continuous glucose monitor. The system will collect CGM data, smartwatch-derived activity, sleep, and vital sign data, and app-based behavioral information such as meals, physical activity, and medication use. Participants will continue usual diabetes care and will not receive treatment recommendations from the study team. Data will be used to develop and validate glucose prediction models and Artificial Intelligence (AI)-generated research outputs that will be reviewed by the study team and not delivered to participants.
Primary outcome measures
Root Mean Square Error of CGM Glucose Prediction Model
Time frame: Up to 3 Month follow-up
Model performance will be evaluated using root mean square error to compare predicted continuous glucose monitor glucose values with observed continuous glucose monitor glucose values. Model performance using continuous glucose monitor data alone will be compared with model performance using continuous glucose monitor data plus behavioral measures, including physical activity and diet logs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-75 years old
- Registered patient under Johns Hopkins Medicine (JHM)
- Type 2 Diabetes diagnosis
- Diabetes managed by a primary care physician or endocrinologist at JHM
- Android Smartphone user
- Must have a Dexcom G7 or FreeStyle Libre 3 CGM and using a mobile app to access their CGM data (G7 or Libre 3 apps)
- 2 weeks of usage (with at least 50% wear time) prior to study participation required
- CGM Time in Range of \<70% in 14 days prior to enrollment
- Must be able to read, understand, and communicate in English
- Must not have hearing or vision impairments
- Willingness to Download the Welldoc app
- Agree to wear a SAMSUNG Galaxy Watch at least 12 hours per day
- Download SAMSUNG Health (Non-SAMSUNG Phone user)
- Download Google Health Connect
- Use CGM at least 80% of the time
- Take a photo of all meals
Exclusion criteria
- Non-English speaker
- Has hearing or vision impairment
- Use of an insulin pump (i.e. automated insulin delivery system)
- Diagnosed with other forms of diabetes (e.g. Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA), Maturity-Onset Diabetes of the Young (MODY), or Gestational diabetes)
- Non-Android smartphone user (i.e., Apple iOS)
- CGM time-below-range \> 4% (i.e. hypoglycemia) in the 14 days prior to enrollment.
- Hospitalization for Diabetic Ketoacidosis (DKA) or severe hypoglycemic episode within the previous 6 months.
Where
- Baltimore, Maryland
Collaborators
Samsung Research America, Welldoc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations