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Search / Trial NCT07116902

Artificial Intelligence-based Methods to Predict Disease Progression in Youth With Type 2 Diabetes

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 6, 2025

Trial Information

Current as of September 06, 2025

Not yet recruiting

Keywords

T2 D Type 2 Diabetes Ai Artificial Intelligence Cgm

ClinConnect Summary

This clinical trial is studying a new way to predict how Type 2 Diabetes (T2D) might change over time in young people. Researchers are using Artificial Intelligence (AI) to create a “digital twin” — a virtual copy of a patient — that can help forecast changes in blood sugar levels and the chance of developing diabetes-related complications. By using information like medical history, genetics, medications, and lifestyle, the AI model aims to better understand each person’s unique disease progression. The study will compare these AI predictions with real health outcomes over a year and see if sharing this information helps young people stick to their treatment and lifestyle plans.

Young people aged 10 to 21 with Type 2 Diabetes, who have had the condition for at least three months and have blood sugar levels above a certain level (HbA1c of 7% or higher), may be eligible to join. Participants should have a stable medication routine and be able to wear a continuous glucose monitor (a device that tracks blood sugar) for six weeks. The study will include about 50 participants, split into two groups to compare outcomes. Those interested should be able to speak English or Spanish and willing to follow study instructions. This research is not yet recruiting but aims to find better ways to support young people with Type 2 Diabetes by using cutting-edge technology to personalize care.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 10- 21 years
  • Diagnosis of T2D based on clinical diagnosis or ICD 9 and 10 codes
  • Duration of T2D ≥ 3 months
  • HbA1C ≥ 7% which is the target HbA1C recommended by the American Diabetes Association
  • Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment)
  • Ability to wear CGM for a total of 6 weeks while in the study.
  • English or Spanish speakers.
  • Willing to abide by recommendations and study procedures.
  • Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
  • Exclusion Criteria:
  • Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, ZnT8).
  • Plan for undergoing bariatric surgery during the study period
  • Anticipated use of systemic glucocorticoids during the study period
  • Unable to stop taking more than 500mg/day of Vitamin C during the study period as this may affect the sensor readings.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Presence of a condition or abnormality that in the opinion of the Investigator would cause repeated hospitalizations or significant changes in medications.

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

Oakland, California, United States

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Shylaja A Srinivasan, MD

Principal Investigator

University of California, San Francisco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported