Doctors at Lucile Packard Children’s Hospital Stanford led the way in testing the device and are currently in the next phase of studying the technology in younger children.
A study published in the Journal of the American Medical Association in mid-September, detailed the successful multicenter trial testing the safety of a closed-loop insulin delivery system in patients with type 1 diabetes (T1D). This closed-loop system, also known as the “artificial pancreas” uses a control algorithm to automatically adjust insulin delivery based on subcutaneous glucose sensor data to improve diabetes management. On September 28, the FDA announced the approval of the device tested in the study, Medtronic’s MiniMed 670G hybrid closed-loop system, which is expected to be available by prescription in March 2017.
Bruce Buckingham, MD, director of pediatric endocrinology at Lucile Packard Children’s Hospital Stanford and an author on the study has dedicated the past 8 years to working with artificial pancreas (closed-loop) teams from academic centers and industry, across the country. He works with a team of outstanding clinical research coordinators and assistants to do closed-loop studies in the Stanford Clinical and Translation Research Unit at Packard Children’s Hospital.
“The artificial pancreas is a historic advancement for T1D care,” said Buckingham. “It means that patients can have unprecedented levels of control with minimal manual intervention and monitoring overnight. Better management means less risk for the complications and long-term effects associated with type 1 diabetes.” Acutely, diabetes can cause severe low blood glucose levels which can result in seizures or loss of consciousness, and many of these occur at night. The closed-loop system will greatly reduce the risk of these occurring and allow people with diabetes to wake up with a near normal glucose.
Twelve adolescents participated in this three month study at Stanford, and most have continued to use the system in an extension phase for an additional six months. For patients like Tia Geri, 16, of Los Altos who attends Foothill Middle College and has lived with T1D for nearly eight years, this device is a whole new life.
“I pretty much don’t go low at night anymore,” said Tia. “It feels pretty amazing to know that I don’t need someone there to monitor me during the night.”
Her mom, Tamar, couldn’t agree more. “I can sleep through the night. I can send her away to camp. It’s a peace of mind I didn’t have a year ago.”
Tia, who is active in soccer and lacrosse, has lots of experience in testing artificial pancreas closed-loop devices; she has participated in at least seven studies previous to the most recent. But, this was different. As she stated, “this was the first one (device) that was really ‘market-ready’ – it was awesome to wear it exactly how it will come out next year.”
“We’ve been active in trials because we like to know what’s out there and what’s being done,” said Tamar, who runs a nonprofit, Carb DM, whose mission is to build a supportive community that improves the quality of life and health of all those affected by type 1 diabetes.
“For us, it was easy to trust the system right from the start because we had used Medtronic technology for a long time prior to the study. I know it may take others in the T1D community longer to be comfortable with it.” Said Tamar. “But I hope that with the results from the study, and the personal stories of all the people who have been using the system for so long, they will be able to make the switch to an easier way of managing their own or their children’s diabetes, sooner rather than later.”
More about the clinical trials
The Stanford team holds closed-loop studies in hotels, rental home properties and at diabetes camps. The team was the first to test the Medtronic 670G pump. The initial studies were done at a diabetes camp in Southern California (Camp Chinnock) in 2014, and later that year Dr. Buckingham directed a multicenter study with Yale and the University of Colorado to further evaluate the closed-loop system in an outpatient setting. This last year the Stanford team was part of the multicenter pivotal trial that resulted in FDA approval. The twelve adolescents have used the system at home for more than 6 months, doing their usual activities, including intense sports and driving a car while in “closed-loop.”
“Now we are currently studying this technology for children 7 to 14-years-old”, said Buckingham. “In the near future we will study children less than 6 years of age in order to make this therapy available to all children with diabetes.
To learn more about closed-loop system, join us on October 20th at a meeting in the hospital’s Auditorium at 7 PM.
Learn more about Diabetes & Endocrinology.
- Samantha Dorman
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