NIH funds the first trial of artificial pancreas for pregnant women with type 1 diabetes in the United States.

The National Institutes of Health has awarded a R01 grant to a multi-institutional team to develop and evaluate a pregnancy-specific artificial pancreas as part of a series of clinical and transient clinical trials. The researchers hope that the first studies in the country will lead to a safe and effective home-based clinical trial, with an extension phase until the end of pregnancy.

The project brings together the team of experienced engineers from the Harvard School of Engineering and Applied Science John A. Paulson and a clinical research consortium composed of school specialists. Icahn Medicine at Mount Sinai, Mayo Clinic and Sansum Diabetes Research Institute.

"This work will take our previous advances in artificial pancreas technology to a higher level and will be the first such project in the US," said Dr. Eyal Dbadau, Senior Researcher, Director of the Systems Engineering Research Group. Biomedical Harvard John A. Paulson School of Engineering and Applied Sciences.

"Achieving and maintaining the very narrow blood glucose range required to achieve the best fetal outcomes in pregnant women with type 1 diabetes is extremely difficult, even with optimal clinical care," said Carol J. Levy, MD, CDE, Clinical director of Mount Sinai Diabetes Center, which has managed the care of hundreds of pregnant women with this disease and is the principal investigator of the project at the Icahn School of Medicine at Mount Sinai. "The use of personalized technologies provides an important opportunity to improve outcomes for the patient and the fetus.We are delighted to be part of the team that is evaluating this important area of ​​research designed to improve the quality of life." care and reduce the burden on patients. "

"Women with type 1 diabetes have significant insulin reactions when they try to manage their blood glucose levels in a narrow target range throughout pregnancy." had no trials of artificial pancreas involving pregnant women with type 1 diabetes in the United States, "said Yogish C. Kudva. Professor of Endocrinology at Mayo Clinic Rochester. "We are excited to be able to adapt the automated administration of insulin to ease the burden of pregnant women with type 1 diabetes and their families."

"This project will adapt the artificial pancreas to help pregnant women at every stage of pregnancy, going from a series of clinical studies to an outpatient trial," said Dr. Jordan Pinsker, the # 39, principal investigator of the project at the Sansum Diabetes Research Institute (SDRI). "This project continues the legacy of the work of Dr. Lois Jovanovic, who has conducted her revolutionary clinical trials at SDRI for 27 years, laying the groundwork for current standards of care for diabetes and pregnancy."

The first clinical trial of the grant, entitled Longitudinal Observation of Insulin Requirements and Sensor Use During Pregnancy (LOIS-P), is named after Dr. Lois Jovanovic and is now on clinicaltrials.gov (NCT03761615). ). This study is currently recruiting pregnant women with type 1 diabetes and will monitor their blood glucose results throughout pregnancy and during the postpartum period.

About the research consortium:

Harvard John A. Paulson School of Engineering and Applied Science (SEAS)

SEAS serves as a connector and integrator for Harvard's teaching and research efforts in engineering, applied sciences and technology. Through the collaboration of researchers from all Harvard neighborhoods, other universities, and corporate and foundation partners, we bring discovery and innovation directly to the service of improving human life and society. . http: // seas.Harvard.edu.

Icahn School of Medicine at Mount Sinai

The Type I Diabetes Research Program at Icahn School of Medicine in Mount Sinai focuses on clinical research projects specifically designed to improve the lives of patients with diabetes. The basic research and clinical research on diabetes at Mount Sinai goes back to the discovery of the radioimmunobaday for measuring serum insulin levels conducted by Nobel laureate Rosalyn Yalow, Ph.D. in 1977 program in New York. The goal of all diabetes research at Mount Sinai is to continue to develop new treatments and improve patient care until healing.

Mayo Clinic Rochester, MN

The Mayo Clinic Rochester Type 1 Diabetes Research Program is closely integrated with the Diabetes Technology Clinic, which is a multi-disciplinary effort with endocrinologists, nurse practitioners, EDCs, and appliance technicians. The research program has been conducting AP studies since 2013 and is currently conducting several AP studies in collaboration with academic engineering partners, such as the Harvard School of Engineering's AP program and industry partners. The Division of Endocrinology has been involved in insulin research since 1922 and has also played a key role in the early development of complex insulin therapy from 1975 to 1985.

Sansum Diabetes Research Institute

More recently, SDRI was the only US clinical site of the flagship CONCEPTT clinical trial, in which 325 pregnant or near-pregnant women were randomized to monitor their blood glucose continuously or self-monitor their blood glucose levels. finger up to delivery. Dr. Jovanovic did her groundbreaking work at SDRI for 27 years, from 1986 to 2013, laying the groundwork for current standards in diabetes and pregnancy management. Dr. Jovanovic was the former Director General and Scientific Director of SDRI from 1996 to 2013.

"Ms. Jovanovic's courageous and tireless struggle to teach the world how to care for women with diabetes has led to an overall improvement in outcomes for mothers with diabetes and their babies," said Dr. Kristin Castorino, co-researcher for the project. . at SDRI.

"It is an honor for us at SDRI to continue Dr. Jovanovic's legacy to improve the treatment of pregnant women with diabetes. Moving forward in this area has always been part of SDRI's commitment to our community and the diabetes community in general. Diabetes research and innovation for people with type 1 diabetes, type 2 diabetes, or gestational diabetes, "said Ellen Goodstein, executive director of SDRI.