Researchers at Harvard University and the University of Virginia have started one of the largest-ever long-term studies to evaluate a so-called “artificial pancreas” system that could change the way Type 1 diabetes is treated.
But one of the nation's leading endocrinologists warns that it could bring headaches to the industry as it learns how to get reimbursed for advice given in between visits.
The device isn't a replica organ, but rather a combination of a continuous blood glucose monitor and an insulin pump enabled by a complex algorithm within a smartphone app. Researchers hope the system will more effortlessly and proactively supply insulin to Type 1 diabetics, who must constantly check their blood glucose levels. About 1.25 million Americans have the disease.
Though Dublin-based Medtronic offers a pump and continuous glucose sensor combination that can momentarily pause insulin delivery if blood glucose levels get too low, systems currently on the market aren't able to more widely react autonomously to changes in blood glucose levels.
The artificial pancreas technology would increase and decrease insulin dosage throughout the day based on glucose levels, exercise and other factors, said Molly McElwee-Malloy, head of patient engagement and director of marketing at TypeZero Technologies, which has developed the system.
If the studies prove successful, TypeZero's system would be able to use trend data to predict blood glucose levels in advance so that insulin can be proactively delivered to avoid hyper- or hypoglycemic episodes, which can land patients in the emergency room.
“It takes away the minute-to-minute management of diabetes and frees people of having to think of it over time,” said Boris Kovatchev, the study's principal investigator and director of the UVA Center for Diabetes Technology.
Dr. George Grunberger, president of the American Association of Clinical Endocrinologists, acknowledged that the devices could bring a sea change in the treatment of diabetes, if even just for the ability to let diabetics sleep instead of frequently waking them up to deal with fluctuating blood glucose levels.
But he warned that it could also bring rough waters, as providers consider reimbursement.
Boston University researchers reported last year that a phone-enabled device showed significant potential in helping Type 1 diabetics maintain control of their blood sugar.
As devices become more and more sophisticated, they'll help patients stay out of the ER and doctor's office, said Grunberger, who leads a diabetes-focused practice group in Bloomfield Hills, Mich. But patients will still need to talk to physicians over the phone or by email to go over data, he said, so payers need to devise a plan for compensating physicians for virtual work.
“I have 500 to 600 (insulin) pumps in my practice but I don't get paid unless (patients) come in and get advice from me,” Grunberger said.
The device will be tested on 240 patients in nine sites in the U.S. and Europe, beginning this year. Researchers hope to adjust their algorithms and evaluate the efficacy of the device so that they can eventually acquire the data necessary for approval by the U.S. Food and Drug Administration.
Researchers received $12.7 million for the project from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. It is the largest award the agency has given under a recently launched $20 million program to study artificial pancreas systems. Studies at the University of Cambridge, Boston University and Massachusetts General Hospital, and a European consortium have also received grants.