Buckingham noted that the advance wouldn’t be possible without the willingness of people like the Kurtzigs to participate in trials. “We have been very fortunate to have a diabetes community that’s interested in doing studies and collaborating with us,” he said.

Knowing that the device is not yet FDA-approved for children younger than 14, Sara Kurtzig is committed to the importance of participating in trials.

“We’ve had such a positive experience and have reached a new level of stability in Jamie’s glucose control. So if we can play a part in making this technology available to all Type 1 diabetes patients, it feels like we are really making a difference,” she said.

Jamie blogs about her experience and said the device has given her both freedom and responsibility she didn’t have before. “I do more things for myself now, but I still have to deliver insulin manually when I’m eating carbs because it doesn’t do that on its own yet,” she said.

The Kurtzigs believe the improved control Jamie has seen with her closed-loop system has been worth the pricks, pokes and inconveniences that come with it. “I wanted to sleep better and I wanted my mom to sleep better. I also really wanted to help other families and to contribute to science all around the world. Because of the trial, I really feel like I get to be a part of diabetes history,” Jamie said.

Refining the systems

The goal of hybrid closed-loop systems is to make patients’ diabetes care less of a burden and to keep their glucose values in a safe range so they can be healthier. To make further progress toward this goal, the Stanford team has been part of a multicenter, NIH-funded study group that is trying to eliminate the need for patients to give themselves an insulin dose (or bolus, as it is known in the diabetes world) before eating — an onerous task, particularly when it has to be done at every snack and every meal.

Part of our mission is to ensure that the system will be used properly by young patients.

“In today’s closed-loop systems, the insulin comes on a little slower and lasts a little longer than we would like,” said Buckingham. “Those lag times make it difficult to provide insulin delivery for a meal in a full closed-loop system. We are looking forward to working with fast-acting insulins — and more rapid delivery — to improve meal glucose control and decrease the daytime burden of diabetes.”

To that end, Stanford is the only institution involved in four National Institute of Diabetes and Digestive and Kidney Diseases research projects, which begin in the 2017-18 fiscal year. The projects will test multiple automated, closed-loop devices in what could be the final steps before requesting regulatory approval for permanent use.

Korey Hood, PhD, professor of pediatrics and of psychiatry and behavioral sciences at the School of Medicine, will lead the pediatric diabetes psychology research team that is investigating how to best help children and their families use these systems, and is partnering with Buckingham on the research.

“Part of our mission is to ensure that the system will be used properly by young patients, meaning that it has the desired impact on both a patient’s health and quality of life,” Hood said. “To that end, we evaluate the user experience by administering surveys and focus groups, and then we use those responses to generate new strategies and solutions to help the closed-loop system user.”

Testing the “bionic pancreas”

Because the pancreas controls glucose both by releasing insulin to lower glucose levels and by releasing glucagon to raise glucose levels, another approach to closed-loop control is to give both insulin and glucagon. Stanford has participated in an NIH-funded, multicenter study that is testing the “bionic pancreas” developed at Boston University. This system has the potential to eliminate the need for carbohydrate counting before meals while also preventing hypoglycemia through the provision of glucagon. The Lancet recently published an article on this study.

David Maahs, MD, the new division chief of pediatric endocrinology at Packard Children’s, said the program will continue “paving the way for better care, not just for our patients at Packard Children’s, but for people with Type 1 diabetes everywhere.”