The National Institutes of Health has awarded a R01 grant to a multi-institutional team to develop and evaluate a pregnancy-specific Artificial Pancreas in a sequence of in-clinic and transitional environment clinical trials.
Image: NIH funds first artificial pancreas study in the US. Photo: Courtesy of Michalina/Unsplash.
The researchers hope that the first-in-the-nation studies will lead to a safe and effective at-home clinical trial with an extension phase to the end of pregnancy.
The project brings together the experienced engineering team of the Harvard John A. Paulson School of Engineering and Applied Sciences (Cambridge, MA), and a clinical research consortium made up of specialists from the Icahn School of Medicine at Mount Sinai (New York, NY), the Mayo Clinic (Rochester, MN), and the Sansum Diabetes Research Institute (Santa Barbara, CA).
“This work will bring our previous advancements in artificial pancreas technology to the next level, and will be the first project of its kind in the United States,” said Principal Investigator Dr. EyalDassau, Director of the Biomedical Systems Engineering Research Group at the Harvard John A. Paulson School of Engineering and Applied Sciences.
“Achieving and maintaining the very narrow range blood glucose levels required for the best fetal outcomes for pregnant women with type 1 diabetes is extremely challenging, even with optimal clinical care,” said Carol J. Levy, MD, CDE, Clinical Director of the Mount Sinai Diabetes Center, who has managed the care of hundreds of pregnant women with this condition and serves as the project’s principal investigator at the Icahn School of Medicine at Mount Sinai. “The use of customized technology provides an important opportunity to improve patient and fetal outcomes. We are excited to be part of the team evaluating this important area of research designed to improve care and reduce patient burden.”
“Women with type 1 diabetes experience significant insulin reactions as they try to manage their glucose within a narrow target range throughout pregnancy. There has been no artificial pancreas trial involving pregnant women with type 1 diabetes in the U.S.,” states Yogish C. Kudva, Professor of Endocrinology at Mayo Clinic Rochester. “We are excited that we will adapting automated insulin delivery to relieve the burden on pregnant women with type 1 diabetes and their families.”
“This project will adapt the artificial pancreas to help pregnant women at each stage of pregnancy, progressing from a sequence of in-clinic studies to an outpatient trial,” said Dr. Jordan Pinsker, principal investigator of the project at Sansum Diabetes Research Institute (SDRI). “This project continues the legacy of the work of Dr. Lois Jovanovic, who performed her groundbreaking clinical trials at SDRI for 27 years, laying the foundation for the current standards of care in diabetes and pregnancy.”
The first clinical trial in the grant, Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (LOIS-P), is named after Dr. Lois Jovanovic, and is now listed on clinicaltrials.gov (NCT03761615). This study is currently enrolling pregnant women with type 1 diabetes and will follow their glycemic outcomes throughout pregnancy and into the post-partum period.
Source: Company Press Release