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Studies

Observational Not yet recruiting

NCT06280729 on ClinicalTrials.gov

AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study

Official title: A Retrospective Observational Study to Use Artificial Intelligence for Prediction of Disease TRajectorY in DIAbetes

  • Sponsor: IRCCS Ospedale San Raffaele
  • Enrollment: 10000 (Estimated)
  • Study start: 2024-03-01 (Estimated)
  • Primary completion: 2025-03-01 (Estimated)
  • Study completion: 2026-03-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Intervention / Treatment

  • Other: AI-Analyis

Primary Outcome Measures

  • Primary Endpoint (0-36 month)
    Development and validation of a model to predict Partial Clinical Remission (PCR) to identify individuals diagnosed with T1D who are most likely to undergo PCR in the early stages of the natural history of the disease. The definition for PCR, namely glycated hemoglobin adjusted for insulin dose (IDAA1c), will be evaluated at 6 and 12 months after the onset of diabetes. Remitters and nonremitters will be dichotomously divided by IDAA1c ≤9 and IDAA1c \>9
  • Primary Endpoint (0-36 month)
    Development and validation of a model to predict the development of chronic complications in patients with diabetes
  • Primary Endpoint (0-36 month)
    Development and validation of a model to predict the response to different second lines of therapy in addition to metformin in patients with T2D who have failed the first line with metformin alone.

Countries

Italy

Locations and Investigators

  • Diabetes Research Institute-IRCCS Ospedale San Raffaele, Milan, Italy

Study Officials