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

Official title

Artificial Intelligence-based Methods to Predict Disease Progression in Youth With Type 2 Diabetes: A Digital Twin Study

Overview

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).

Interventions

• Device 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.
• Other 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.

Primary outcome measures

• Change in HbA1C [Time frame: From enrollment to the close out visit at the 1-year mark]

Secondary outcome measures (10)

• Sleep Quality [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• Psycho-Social Outcome [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• Sugar Intake [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• Physical Activity [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• BMI [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• CGM Time In Range [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• CGM Time Above Range [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• Psycho-Social Outcome [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• Psycho-Social Outcome [Time frame: From time of enrollment to the study close out visit at the 1-year mark]
• Psycho-Social Outcome [Time frame: From time of enrollment to the study close out visit at the 1-year mark]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 2 centers

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

Identifiers

NCT: NCT07116902 · 24-42259 · #7-24-ICTST2DY-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗