From left: Carol J. Levy, MD; Camilla Levister, NP; Co-Investigator Grenye O’Malley, MD, Assistant Professor of Medicine (Endocrinology, Diabetes and Bone Disease); and Clinical Research Coordinator Selassie Ogyaadu, MD, MPH.
An artificial pancreas system tailored to the specific, and daunting, challenges faced by pregnant women with type 1 diabetes is the goal of a study to be conducted by a consortium of four leading institutions, including the Icahn School of Medicine at Mount Sinai. The project, funded by the National Institutes of Health, is the first of its kind in the United States.
“Pregnant women with type 1 diabetes typically test their blood sugars seven to eight times per day, and many wear glucose sensors, but they still struggle tremendously to keep their blood sugar levels in target ranges,” says Carol J. Levy, MD, Clinical Director of the Mount Sinai Diabetes Center, and the project’s principal investigator at the Icahn School of Medicine.
If blood sugar levels are too low for a prolonged period of time, a pregnant woman can feel poorly, or pass out, and risks seizures. If levels rise too high, there are risks to her unborn child, including malformations, delayed lung maturity, placental malfunction, or fetal death. “The use of customized technology provides an important opportunity to improve patient and fetal outcomes,” says Dr. Levy, Associate Professor of Medicine (Endocrinology, Diabetes and Bone Disease), Icahn School of Medicine at Mount Sinai. “We are excited to be part of the team evaluating this important area of research designed to improve care and reduce patient burden.”
The clinical trials will be conducted by specialists at three sites: Mount Sinai; the Mayo Clinic in Rochester, Minnesota; and the Sansum Diabetes Research Institute in Santa Barbara, California.
The overall principal investigator is Eyal Dassau, PhD, an expert on algorithm design and Director of the Biomedical Systems Engineering Research Group at Harvard University’s John A. Paulson School of Engineering and Applied Sciences.
Each patient participating in the artificial pancreas portion of the study will wear a Dexcom G6 continuous glucose monitoring device and an insulin pump. Both devices are linked with a software algorithm on a smartphone, which identifies a personalized blood-glucose range and prompts doses of insulin with reduced input from the patient. This is also known as a closed loop system because it uses a customized algorithm to close the decision-making loop between the glucose reading and the delivery of insulin, with the goal of improving blood sugar control.
In the artificial pancreas, or closed loop system, a controller—consisting of a software algorithm on a smartphone—receives readings from a continuous glucose sensor and prompts doses from an insulin pump, with reduced input from the patient.
The only artificial pancreas approved by the U.S. Food and Drug Administration is the Medtronic 670G. But it is designed for blood glucose targets between 120 milligrams/deciliter (mg/dL) and 180 mg/dL, while pregnant women with type 1 diabetes aim for a narrower range—under 90 mg/dL while fasting and 130 to 140 mg/dL one hour after meals.
“This is not easy to do, even for the most meticulous patients,” says Dr. Levy. Another challenge is that hormonal shifts in each trimester change the level of resistance to insulin, making the proper dose “a moving target.”
The first clinical trial in the grant—Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (LOIS-P)—is now enrolling 50 pregnant women with type 1 diabetes and will follow their glycemic outcomes into the postpartum period, providing guidance in refining the algorithm. The trial is named for the late Lois Jovanovic, MD, who was a former director of the Sansum Institute and a role model for many in the study of diabetes, including Dr. Levy. The overall project is intended to progress from a sequence of in-clinic studies to a safe and effective at-home clinical trial.
“I view this work as critical for patients, and I have a personal perspective as well, since I have had type 1 diabetes for 48 years,” Dr. Levy says. “I managed my diabetes with my health care team through two pregnancies, and every day was a challenge. Caring clinicians are important, and any support that people with type 1 diabetes can have provides a huge difference. Every time I enroll a patient in the LOIS-P study, I feel as if we are one step closer to a real answer for many women.”
For more information about the clinical trials, call 212-241-9089.