Recruiting

Diabetes Management

Sponsor:

Johns Hopkins University

Code:

NCT07633171

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Digital Health Data Collection System

Study Details

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.

Conditions

Type 2 Diabetes

Study ID

NCT07633171

Start date

Oct 7, 2026

Status verified date

Oct, 2026

Completion date

Feb 26, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Root Mean Square Error of CGM Glucose Prediction Model [ Time Frame: Up to 3 Month follow-up ]

Central Contacts and Locations

Central contacts

Nestoras Mathioudakis, MD, MHS

410-955-3663nmathio1@jhmi.edu

Gordon Gao, PhD

410-234-9450.ggao8@jh.edu

Locations

Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Nestoras Mathioudakis, MD, MHS

410-955-3663nmathio1@jhmi.edu

Gordon Gao, PhD

410-234-9450.ggao8@jh.edu

Principal Investigator:

Nestoras Mathioudakis, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.