NIH Hosts Discussion On Emerging Artificial Pancreas Technology
As several artificial pancreas (AP) systems edge their way toward the U.S. market, the National Institutes of Health (NIH) is hosting a workshop to discuss the technology with government agencies, patient advocacy groups, and industry stakeholders. The Institutes’ “multidisciplinary discussion” is expected to cover clinical trial modalities, reimbursement concerns, and ways to direct research that may accelerate a safe and effective AP system for diabetic patients.
An AP system — which would monitor a patient’s glucose 24 hours per day and automatically administer insulin, as needed — is expected to dramatically improve a diabetes patient’s quality of life and potentially reduce the risk of highly debilitating comorbid conditions, which can occur when the condition is poorly managed.
According to CDC estimates, 29.1 million Americans (9.3 percent of the population) have diabetes, and 1.4 million patients are diagnosed in the U.S. every year. The condition costs the U.S. economy roughly $245 billion per year, with $176 billion attributed to healthcare costs and $69 billion to productivity losses.
Though AP technology has hovered on the horizon for quite some time, there is no all-in-one diabetes management system currently available on the U.S. market — though several medtechs are in the process of testing their systems, and some have projected regulatory approval as early as 2017.
Medtronic recently fast-tracked its path to AP technology with the launch of a hybrid closed loop trial, and the NIH issued a $12.7 million grant to fund the largest clinical trial of AP technology in the country, using TypeZero’s inControl AP platform.
“Our foremost goal is to establish a new diabetes treatment paradigm,” said Boris Kovatchev, principal investigator of the studies at University of Virginia. “The artificial pancreas is not a single-function device; it is an adaptable wearable network surrounding the patient in a digital treatment ecosystem.”
The organizing committee of the NIH workshop, to be hosted in July, includes Guillermo Arreaza-Rubin, director of the Diabetes Technology Program at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), as well as representatives from the FDA, Juvenile Diabetes Research Foundation (JDRF), and prominent diabetes research facilities nationwide.
According to the NIH, workshop participants will discuss “current and emerging systems and their components,” including “ integration strategies, clinical testing modalities, psychosocial and usability factors, regulatory and reimbursement considerations, and prospective areas of research to accelerate availability” of AP systems.
Separate components of a “closed loop” system — such as insulin pumps, continuous glucose monitors, and smartphone apps — already exist on the market, and many diabetes patients are impatiently awaiting access to a fully automated management system.
The Open Artificial Pancreas System (APS) was designed by a diabetes patient and her husband using these existing parts and a couple lines of code, which they’ve made available to other diabetes patients on the internet. Though this system has not received regulatory approval, over 40 patients are using some version of this homemade system, which uses a Medtronic insulin pump and a Dexcom CGM system, according to the New York Times.