SIF88 PrIMeD

Project Manager: Boris Kovatchev, School of Medicine

The Virginia PrIMeD Project: Precision Individualized Medicine for Diabetes: The purpose of this project is to detect, control (includes artificial pancreas), and cure type 1 diabetes. 

BoV Approved: December 2016

Project Dates: 2/9/2017 – 2/28/2022

Total Funding: $16,992,531

Executive Summary

Detection -> Control ->Cure. In the world of type 1 diabetes (T1D), these words represent a process that begins with genetic screening and early detection, employs the artificial pancreas to optimally control the disease, and aspires to a cure that will defy autoimmunity and regenerate beta cells. Interdisciplinary teams led by Drs. Stephen Rich, Boris Kovatchev and Andy Basu, and Larry Lum, respectively, are interacting through this award to create a research and clinical environment that is unique, and which positions the University as a World leader in the T1D field. The strategic goals  of this project are: 

1. Detection: Establish a statewide network to provide genetic screening for T1D;
2. Control: Create new Diabetes Data Science to unleash the power of analytics and offer: a. Optimal diabetes control based on UVA’s advanced artificial pancreas technology; b. An interdisciplinary Graduate Program to students with science/engineering background; and c. A State-of-the-art Clinical Center to bring technology to patients;
3. Cure: Chart the road by investing in emerging immunotherapies and islet replacement treatments.

Current Status: Completed

Achievements

The Virginia PrIMeD Project was structured into three principal programs: DetectionControlCure of type 1 diabetes (T1D), led by Drs. Rich, Kovatchev, and Lum, respectively. These programs created a research and clinical environment that positioned the University as a world leader in the T1D field. Highlights include: 

1. Detection: This program evaluated genetics as an indicator of who would benefit from autoantibody testing and avoidance of T1D. We recruited ~3,700 children (between 2-16 years) from pediatric clinics, obtained a spit (saliva) sample, and applied a type 1 diabetes genetic risk score to identify those at “high genetic risk”; 14% of those tested had a “high genetic risk.” A simple educational sheet of signs and symptoms of T1D resulted in improved recognition of potential disease development. The success of using spit samples for DNA testing suggests that mailing in-home kits could scale for population screening.
2. Control: PrIMeD project has created unique research, translational, and clinical infrastructure at the Center for Diabetes Technology (CDT), which is now the #1 diabetes technology group in the world, as evidenced by multiple publications in top journals, patents, federal grants, industry contracts, and invitations to speak at international conferences:
   • We introduced Diabetes Data Science – a new field in which CDT has a recognized lead; 
   • With NIH funding and PrIMeD infrastructure, the CDT led the 3 largest Artificial Pancreas clinical trials to date, and successfully translated the technology to the clinical practice - the Control-IQ system based on CDT algorithms now has >400,000 users worldwide; 
   •  A new Advanced Diabetes Management Clinic was created, led by Dr. Basu, to bring advanced diabetes technologies to the UVA Health System.
3. Cure: Two new types of inducible T regulatory cells (iTregs) were developed for adoptive transfer into T1D patients to suppress the pancreatic inflammation that leads to destruction of the pancreatic β cells. A new method for producing iTregs was developed that is simpler, less manipulative, and less expensive than existing methods. Three recombinant PDL1 proteins were produced and partially characterized. PrIMeD supported development of using bispecific antibodies to target the iTregs to IA-2 specific tissue in T1D.

Additional Development: An islet transplantation/bio-artificial pancreas program was initiated in collaboration with Dr. Oberholzer, UVA Transplant Center. FDA approval was obtained for the new cGMP facility for human islet isolation from pancreata from multi-organ donor. PrIMeD also allowed to further develop our biochip technology for studying insulin producing cells and other tissues.