NCT07633171

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 2, 2026

Last Update Submit

June 5, 2026

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Root Mean Square Error of CGM Glucose Prediction Model

    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.

    Up to 3 Month follow-up

Secondary Outcomes (10)

  • Number of Meal Logs Submitted Per Participant

    Up to 3 Month follow-up

  • Number of Physical Activity Logs Submitted Per Participant

    Up to 3 Month follow-up

  • Number of Medication Logs Submitted Per Participant

    3 month follow-up

  • Number of Mood Logs Submitted Per Participant

    Up to 3 Month follow-up

  • Percent of Expected Continuous Glucose Monitor Data Captured Per Participant

    Up to 3 Month follow-up

  • +5 more secondary outcomes

Study Arms (1)

Adults With Type 2 Diabetes Using CGM

Adults with type 2 diabetes receiving care through Johns Hopkins Medicine will participate in a single site observational cohort study. Participants will continue usual diabetes care and will not receive a treatment intervention from the study team. Participants will contribute CGM, smartwatch, app-based behavioral, and electronic medical record data for development and validation of glucose prediction models. Study-generated messages and summary reports will be reviewed by the study team and will not be delivered to participants.

Device: Digital Health Data Collection System

Interventions

Digital Health Data Collection SystemDEVICE

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.

Also known as: Welldoc, Samsung Galaxy Watch, Continuous glucose monitor, Dexcom G7, FreeStyle Libre 3
Adults With Type 2 Diabetes Using CGM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from the Johns Hopkins Medicine adult clinical population. The study population will include adults with type 2 diabetes who receive diabetes care through Johns Hopkins Medicine, including primary care and endocrinology clinics. Participants will be recruited from patients whose routine diabetes care includes use of continuous glucose monitoring and who may be eligible to contribute glucose, wearable, app-based behavioral, and electronic medical record data for development and validation of glucose prediction models.

You may qualify if:

  • 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)
  • 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
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Healey E, Tan ALM, Flint KL, Ruiz JL, Kohane I. A case study on using a large language model to analyze continuous glucose monitoring data. Sci Rep. 2025 Jan 7;15(1):1143. doi: 10.1038/s41598-024-84003-0.

    PMID: 39774031BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nestoras Mathioudakis, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nestoras Mathioudakis, MD, MHS

CONTACT

410-955-3663nmathio1@jhmi.edu

Gordon Gao, PhD

CONTACT

410-234-9450.ggao8@jh.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 26, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)