Diabetes Type 2 clinical trials at UCSF

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).

The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.