Conducting effective Type 1 diabetes (T1DM) trials requires understanding the patient as well as the caregiver, handling the complexity that technology adds to the trial design and paying special attention to the systems that support clinical trials. But many sponsors face challenges when selecting appropriate technology – particularly in a global trial where access and use patterns are varied.
This educational webinar will provide an overview of why T1DM patients are different than T2DM patients and the challenges that arise due to requirements surrounding technology in these trials. Participants will also hear an overview of the Type 1 diabetes patient profile, challenges in management from a patient/caregiver perspective and the current technology-related hurdles in conducting trials in T1DM from a sponsor’s perspective.
The discussion will be led by Dr. Barry Goldstein, Dr. Mansai Jamain and Dr. Sanjoy Dutta, JDRF (the Voice of the Patient), as they share their applicable research experiences and explore the current state of technologies that impact clinical research and planning for registration programs.
Sanjoy Dutta, PhD ,
Associate Vice President, Translational Development, JDRF
Dr. Sanjoy Dutta is the Associate Vice President of Research and Institutional Partnerships at JDRF. He oversees all of the research programs to treat Type 1 diabetes (T1DM) and its complications, including the Artificial Pancreas, Glucose Control, Beta Cell Replacement and Complications portfolios. He is also responsible for international partnerships with world-leading government, non-government, foundation and commercial organizations. Dr. Dutta obtained his doctorate from the department of biochemistry and molecular biology at the University of Southern California and was a JDRF Postdoctoral Fellow in the department of cell biology and the Joslin Diabetes Center at Harvard Medical School. In his postdoctoral training, he developed and studied genetic models of diabetes.
Barry Goldstein, MD, PhD, FACE ,
Vice President &Therapeutic Area Head, Metabolic & Endocrinology, Covance
Dr. Barry J. Goldstein is a board-certified endocrinologist who is an internationally-recognized authority on diabetes mellitus. Dr. Goldstein has over 25 years of broad experience in clinical and basic R&D in Academia and Industry, serving as the PI or Co-PI on nearly 100 clinical trials. He is an elected member of the ASCI and AAP, a past associate editor of the two major journals in his specialty, DIABETES and the Journal of Clinical Endocrinology and Metabolism, and has served on many grant review panels for NIH, ADA, JDRF as well as industry scientific advisory panels. Dr. Goldstein received his combined MD/PhD degrees from the University of Rochester School of Medicine and Dentistry. His postdoctoral research and clinical fellowships were at the Joslin Diabetes Center and Brigham and Women's Hospital, both of Harvard Medical School, where he also served on the medical faculty for several years.
Manasi Jaiman, MD,
Medical Director, Cardiovascular, Metabolic, Endocrine and Renal, Covance
Dr. Manasi Jaiman has extensive clinical and academic experience in pediatric Type 1 diabetes and also provides medical and scientific expertise for clinical trials and protocols in diabetes and diabetes devices. Before joining Covance, Dr. Jaiman was involved in a variety of clinical research activities including a role as a lead clinician for a major Type 1 diabetes program developing a dual-chambered “bionic pancreas” programmed to deliver insulin and glucagon in response to real-time glucose sensor monitoring data in ambulatory patients. Dr. Jaiman received an MPH in Health Systems Management from Tulane University before obtaining her MD degree from the Medical University of South Carolina. Dr. Jaiman completed her pediatric residency at Dartmouth-Hitchcock Medical Center and her Pediatric Endocrinology Fellowship at Massachusetts General Hospital (MGH) in Boston, Massachusetts where she continues to remain on faculty as an Assistant Professor in Pediatrics and Instructor at Harvard Medical School.
- Provide an overview of Type 1 diabetes vs. Type 2 diabetes
- Challenges conducting Type 1 diabetes trials and the technology requirements
- Current state of the technologies for patients with Type 1 diabetes
- Patient considerations when planning for a global Type 1 diabetes trial
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