The National Institutes of Health awarded grant R01 to a multi-institutional development and assessment team for pancreatic artificial pancreas in a series of clinical clinical trials in the clinic and in the transitional environment. The researchers hope that first-country studies in the country will lead to a safe and effective clinical trial of the extended-phase home by the end of pregnancy.
The project brings together an experienced engineering team at the Harvard School of Engineering and Applied Sciences John A. Paulson and a clinical research consortium comprised of specialists from the Medical School of Medicine at Mount Sinai, the Mayo Clinic and the Sansum Diabetes Research Institute.
"This work will bring our previous advances in artificial pancreatic technology to the next level, and will be the first project of its kind in the United States," said lead researcher Dr. Eyal Dassau, director of the Biomedical Systems Research Group Harvard John A. Paulson School of Engineering and Applied Sciences.
"The achievement and maintenance of very narrow blood glucose levels for the best results of the fetus in 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 Diabetes Center in Sinai, who manages the care of hundreds of pregnant women with this condition and serves as a lead researcher at the Medina Medical School at Mount Sinai. "Using customized technology is an important opportunity to improve the results of the patient and the fetus. We are excited to be part of a team that evaluates this important area of research in order to improve care and reduce the burden on the patient."
"Women with type 1 diabetes experience significant insulin responses while trying to manage their glucose within the narrow target range during pregnancy. There was no artificial examination of the pancreas involving pregnant women with type 1 diabetes in the United States," says Yogis K. Kudva, Professor of Endocrinology at the Mayo Rochester Clinic. "We are excited to adjust the automatic delivery of insulin to ease the burden on 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, progressing from a range of clinical studies to an outpatient examination," said Dr Jordan Pinsker, chief research projecter at the Sansum Diabetes Research Institute ( SDRI). "This project extends the legacy of the work of Dr. Lois Jovanovic, who for 27 years has performed her important clinical trials in the SDRI, laying the foundation for current standards for diabetes and pregnancy care."
The first clinical trial in the grant, longitudinal monitoring of insulin requirements and the use of sensors in pregnancy (LOIS-P), was named after Dr. Lois Jovanovic and is now listed at clinicaltrials.gov (NCT03761615). This study currently lists pregnant women with type 1 diabetes and will monitor their glycemic outcomes during pregnancy and postpartum period.
About research consortium:
Harvard John A. Paulson School of Engineering and Applied Science (SEAS)
SEAS serves as a connector and integrator of Harvard's efforts for teaching and research in the fields of engineering, applied science and technology. Through collaboration with researchers from all parts of Harvard, from other universities, as well as with partners from corporations and foundations, we directly and directly discover innovations to improve human life and society. http: // seas.
Icahn Medical School at Mount Sinai
The Type 1 Diabetes Program at the Medical School of Mount Sinai focuses on clinical research projects designed specifically to improve the lives of patients with diabetes. There is a long history of both basic and clinical research on diabetes at Mount Sinai, dating back to the discovery of a radioimmunoassay to measure serum levels of insulin by Nobel laureate Rosalin Yalouv, a doctor of medicine in 1977. Researchers at Mount Sinai are performing a robust outpatient artificial pancreas program in New York. The goal of all Diabetes research on Mount Sinai is to continue developing new treatments and improve patient care until cured.
Mayo Clinic Rochester MN
The Type 1 diabetes program at the Mayo Rochester Clinic is firmly integrated with the Clinic for Diabetes Technology which is a multidisciplinary effort with dedicated endocrinologists, nurses, doctors and CDEs and device technicians. The research program conducted AP studies from 2013 and currently implements several AP studies that work with academic engineering partners, such as the Harvard Faculty of Engineering AP Program and Industrial Partners. The endocrinology department has been involved in the 1922 insulin-related study and has also played a key role in the early development of complex insulin therapy from 1975 to 1985.
Sansum Diabetes Research Institute
Recently, SDRI was the only US clinical site for the CONCEPTT Clinical Trials, where 325 women who were either pregnant or planning a pregnancy were randomized to continuously use glucose monitoring or only to monitor blood glucose (SMBG) only until delivery. Dr. Jovanovic has completed her new job in the SDRI for 27 years, from 1986 to 2013, laying the foundation for current standards for diabetes and pregnancy care. Dr. Jovanovic was former SDRI chief executive and chief research associate from 1996-2013.
"The courage and ruthless struggle of Dr. Jovanovic to teach the world how to care for diabetes women has led to a global improvement in the results for both mothers with diabetes and their babies," says Dr. Christine Castorino, co-investigator of the project in SDRI.
"It is an honor for us in SDRI to continue Dr Jovanovic's legacy to improve the treatment of pregnant women with diabetes. The advancement of her work in this area has always been part of the SDRI's commitment to our community and the diabetes community as a whole to advance diabetes research and innovation for those affected by type 1 diabetes, type 2 diabetes or gestational diabetes, "said Ellen Gustain, executive director of SDRI.