Multimodal Glucose Prediction for Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to build foundation models that integrate continuous glucose monitoring with behavioral data such as food intake, medications, and physical activity to improve real-time glucose predictions. Participants are adults with type 2 diabetes who use CGM devices and smartphones, and who are willing to wear a Galaxy Watch and use specified health apps. The research is conducted under Johns Hopkins University with collaboration from Samsung Research America and Welldoc, deploying digital health data collection and analysis to develop personalized diabetes management insights. Data collection emphasizes real-world usage through mobile and wearable platforms to inform future digital health interventions. The study does not test an intervention in the traditional sense but analyzes multi-modal data to enhance predictive modeling for glycemic control.

Why it matters

Who can join: the full rules

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:

* Pregnant
* 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 it's running

• Johns Hopkins Medicine
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Nestoras Mathioudakis, MD, MHS — Johns Hopkins University
• Study coordinator: Nestoras Mathioudakis, MD, MHS
• Email: nmathio1@jhmi.edu
• Phone: 410-955-3663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.