NIH https://www.nih.gov awarded a grant to a multi-institutional team to conduct clinical trials to evaluate an Artificial Pancreas (AP) to help pregnant women with type 1 diabetes. The team from the Harvard John A. Paulson School of Engineering and Applied Sciences along with a team of specialists from the Icahn School of Medicine at Mount Sinai https://icahn.mssm.edu, the Mayo Clinic https://www.mayoclinic.org, and the Sansum Diabetes Research Institute https://www.sansum.org will work together on the project.
“Women with type 1 diabetes experience significant insulin reactions as they try to manage their glucose within a narrow target range throughout pregnancy. So far, there has been no artificial pancreas trial involving pregnant women with type 1 diabetes in the U.S.” according to Yogish C. Kudva, Professor of Endocrinology at the Mayo Clinic in Rochester.
The first clinical trial to be funded by the grant is the “Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (LOIS-P)” trial which is listed on clinicaltrials.gov (NCT03761615).
The clinical trial started November 2018 and expected to be completed July 2021, will include 50 pregnant women with type 1 diabetes and will follow their glycemic outcomes throughout pregnancy and into the post-partum period.
The data collected will provide information on CGM based glucose insulin delivery, plus provide data on self-monitoring blood glucose and maternal and fetal outcomes. All of the data will be provided from pregnant women with type 1 diabetes. The data will be used to develop and refine algorithms for an AP system tailored to the needs of pregnant women with type 1 diabetes.
“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 U.S,” said PI Dr. Eyal Dassau, Director, Biomedical Systems Engineering Research Group at the Harvard John A. Paulson, School of Engineering and Applied Sciences https://www.seas.harvard.edu.