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

NCT ID: NCT07116902

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2026-09-30

Brief Summary

Currently, clinicians are unable to predict a patient's risk of long-term disease progression and development of a long-term complication based on the data that is available to them. The first aim of this is to develop and validate an Artificial Intelligence (AI) powered prediction model for Type 2 Diabetes (T2D) disease progression using existing data from previously collected studies and real-world electronic health medical data. Investigators will use clinical, pharmacologic, and genomic factors to develop the prediction model based on the most relevant clinical outcomes of change in Hemoglobin A1c (HbA1c) and the development of a microvascular complication.

Despite the availability of newer medication options, lifestyle intervention is not effective in most youth and current therapeutic options are ineffective at producing sustained glycemic control. Newer and innovative methods are needed to identify the youth at highest risk of progression in terms of increase in HbA1c and development of long-term complications and to motivate behavioral change in youth. The goal of this aim is to create an AI-powered digital twin model for 50 youth with T2D using their baseline clinical, genetic, pharmacologic and lifestyle data and utilize AI algorithms developed in Aim 1 to simulate disease progression and treatment response. Investigators will then evaluate the digital twin model in an randomized controlled trail and prospectively compare the generated digital twin data to observed values over one year. Investigators will also measure whether knowledge of the digital twin prediction with targeted healthcare recommendations influence medication and lifestyle change adherence in the digital twin arm (n= 25) compared to the control arm (n= 25).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Digital twin arm

Participants in the digital twin arm will receive information on their disease progression which will be based on projected change in HbA1C in alternative realities and specific recommendations on medication dosing and lifestyle changes based on this data. The digital twin information will be presented on an iPad in a game- like manner. The alternate realities will include scenarios of change in medication adherence, physical activity metrics, dietary changes etc.

Group Type: EXPERIMENTAL

phone application

Intervention Type: DEVICE

Participants in the digital twin arm will receive information on their disease progression which will be based on projected change in HbA1C in alternative realities and specific recommendations on medication dosing and lifestyle changes based on this data. The digital twin information will be presented on an iPad in a game- like manner. The alternate realities will include scenarios of change in medication adherence, physical activity metrics, dietary changes etc.

Control arm

Participants in the control arm will receive standard of care which is medication change recommendations based on HbA1C and blood glucose values every 3 months and standard lifestyle education.

Group Type: PLACEBO_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

Participants in the control arm will receive standard of care which is medication change recommendations based on HbA1C and blood glucose values every 3 months and standard lifestyle education.

Interventions

phone application

Participants in the digital twin arm will receive information on their disease progression which will be based on projected change in HbA1C in alternative realities and specific recommendations on medication dosing and lifestyle changes based on this data. The digital twin information will be presented on an iPad in a game- like manner. The alternate realities will include scenarios of change in medication adherence, physical activity metrics, dietary changes etc.

Intervention Type: DEVICE

Standard of Care (SOC)

Participants in the control arm will receive standard of care which is medication change recommendations based on HbA1C and blood glucose values every 3 months and standard lifestyle education.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Stanford University

OTHER

Sponsor Role: collaborator

American Diabetes Association

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shylaja A Srinivasan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic

Oakland, California, United States

UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes

San Francisco, California, United States

Countries

United States

Central Contacts

Avani A Narayan, MS

Role: CONTACT

avani.narayan@ucsf.edu

415-530-8047

Laura A Dapkus Humphries, NCPT

Role: CONTACT

laura.dapkus@ucsf.edu

628-224-8364

Facility Contacts

Shylaja A Srinivasan, MD

Role: primary

shylaja.srinivasan@ucsf.edu

415-353-9084

Laura A Dapkus Humphries, NCPT

Role: backup

laura.dapkus@ucsf.edu

628-224-8364

Shylaja A Srinivasan, MD

Role: primary

shylaja.srinivasan@ucsf.edu

415-353-9084

Laura A Dapkus Humphries, NCPT

Role: backup

laura.dapkus@ucsf.edu

628-224-8364

Other Identifiers

#7-24-ICTST2DY-05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-42259

Identifier Type: -

Identifier Source: org_study_id