The Mount Sinai Diabetes Center, led by Carol J. Levy, MD, in 2025 continued to expand research to meet the specific and challenging needs of pregnant women diabetes.
Dr. Levy and her team are investigating for the first time a commercial insulin pump closed-loop system that can be set to pregnancy-specific glucose targets for individuals with type 1 and type 2 diabetes. Two other large multisite studies will enable a better of understanding the most appropriate pregnancy-specific glucose sensor targets for people with type 1 and gestational diabetes to optimize maternal and fetal outcomes. In addition, Mount Sinai is evaluating the safety and efficacy of inhaled insulin in pregnant women with gestational diabetes.
“We’re aware of the importance of providing informed care across the broad population of pregnant women who struggle with glucose disturbances,” says Dr. Levy, Director of the Diabetes Center, Professor of Medicine (Endocrinology, Diabetes and Bone Disease), and acting chief of the Division. “The risks of hyperglycemia in pregnancy are extensive for both the mother and fetus. These risks include a higher risk of miscarriage and an increased incidence risk of fetal anomalies in the first trimester, and later on preeclampsia, macrosomia, neonatal hypoglycemia, and newborn respiratory in the third trimester and at delivery. The third trimester risks exist for all pregnancies complicated by type 1 or type 2 diabetes and for those with gestational diabetes."
A pivotal trial will soon open, designed to evaluate a commercial-grade automated insulin delivery system with an algorithm able to target glucose levels into the ranges required for pregnancy. “No closed-loop system in the U.S. currently has an indication for use in pregnancy, in part due not being able to be customized to pregnancy specific metrics,” Dr. Levy says. “This pivotal study with a commercial insulin pump partner could truly be groundbreaking.” Prior work by Dr. Levy’s team showed the feasibility of a closed-loop system able to achieve pregnancy-specific targets.
“We’re aware of the importance of providing informed care across the broad population of pregnant women who struggle with glucose disturbances.”
Carol J. Levy, MD
Dr. Levy is a member of the executive committee, along with Grenye O’Malley, MD, Associate Professor of Medicine (Endocrinology, Diabetes and Bone Disease), for a study that will fill a clinical void by seeking to determine the most appropriate glucose metrics for pregnant women with type 1 diabetes throughout gestation. That trial is enrolling 500 participants across the United States, who will share continuous glucose monitoring (CGM) and insulin pump data to help scientists and their pregnancy outcomes. This multisite trial, known as T1D Pregnancy & Me, is designed to help gauge the optimal percentage of time for women to spend in the pregnancy-specific glucose range of 63-140 mg/dL, as suggested in prior studies, and how women use assistive techniques with commercial systems not customized for pregnancy, as well as the studying the effects of other CGM metrics in each trimester on maternal and fetal outcomes.
Women who have type 2 diabetes—and face a different set of challenges and glucose metrics during pregnancy—are also a priority for Mount Sinai investigators. Researchers plan to include both pregnant individual with type 1 and type 2 diabetes in the clinical trial evaluating a new and innovative automated insulin delivery system with a twist pump that weighs less than two ounces. The algorithm-driven insulin infusion pump automatically increases, decreases, or suspends delivery of basal insulin based on continuous glucose monitor readings and predicted glucose values.
Determining the appropriate glucose time in range and when best to intervene during pregnancies for hyperglycemia are at the forefront of another multisite study in which Mount Sinai is a partner, called the IMAGINE trial. Gestational diabetes affects as many as 20 percent of pregnant women, typically at 24 to 28 weeks of pregnancy, when hormones from their placenta promote worsening insulin resistance. IMAGINE is enrolling women with modest glucose elevations in the first trimester as determined by CGM metrics. “For women who are above a certain level, but have not been diagnosed with gestational diabetes, we are evaluating if providing intervention, be it dietary or medication-based, will improve maternal and fetal outcomes” Dr. Levy says. “What’s exciting about this study is that it will tell us how aggressive we need to be in pregnancies for CGM targets.”
Dr. Levy’s team is also evaluating inhaled insulin as a treatment option for women with gestational diabetes. Their previous work with ultra-rapid-acting inhaled insulin for type 1 diabetes convinced them of its potential in gestational diabetes, given the fact many of these patients are initiated on insulin while pregnant. Mount Sinai is a partner in a five-site feasibility trial of inhaled insulin for gestational diabetes and anticipate reporting study data in mid-2026.
Featured
Carol J. Levy, MD
Director of the Mount Sinai Diabetes Center, and Acting Chief and Professor of Medicine (Endocrinology, Diabetes and Bone Disease)
Grenye O'Malley, MD
Associate Professor of Medicine (Endocrinology, Diabetes and Bone Disease)