FDA approves first ‘artificial pancreas’ for diabetes treatment

The first "artificial pancreas" was developed by Medtronic.

By REBECCA ROBBINS @rebeccadrobbins

The Food and Drug Administration on Wednesday approved the first so-called artificial pancreas, an out-of-body device expected to lift the burden for some diabetics on the daily grind they must go through to keep their blood sugar levels stable. It will be available next spring for patients with type 1 diabetes who are over age 14.

The device, which looks like a smartphone, is designed to automatically monitor and administer the delivery of insulin for type 1 diabetes patients, whose ability to provide insulin naturally is impaired. It wirelessly links up an insulin pump and glucose monitor, allowing patients to partly turn over the process of testing and adjusting their blood sugar levels. It’s not unlike cruise control: Patients still have to manually control their glucose levels before they eat.

In the diabetes community, optimism about the new device is tempered by fears that it will command a high price tag that could put it out of reach for patients already grappling with the soaring cost of insulin. Medtronic, which developed the “MiniMed 670G,” has yet to announce how much it plans to charge. But spokeswoman Leslie Bryant said the company expects to offer it “at currently offered Medtronic pump system pricing” and is talking with health plans to “enable patient access.”

Medtronic’s application was approved on the back of a study that tested how 123 type 1 diabetes patients fared on the device. No patients reported developing complications like excess blood acids or low glucose levels that can result from poor monitoring of the disease.

Medtronic is also testing the device on pediatric patients. One such patient, 13-year-old Jonathan Platt of the Los Angeles area, is still using his device after the completion of the trial. “For our family, it’s been life-changing,” his mother, Angie Platt, said. She said that after an initial adjustment period, blood sugar imbalances that prompt middle-of-the-night trips to Jonathan’s room have been reduced from several times a night to half a dozen times a month.

The device’s approval brought cheers from JDRF, the world’s largest charitable funder of type 1 diabetes research. Over the past decade, the group, formerly known as the Juvenile Diabetes Research Foundation, has aggressively pushed to get such a device to market by funding research and pressing the federal government.

“I’m very excited about the fact that there is a system that will help people lead fuller, safer, higher quality lives,” said Derek Rapp, JDRF’s president and CEO.
Rapp said it’s important that people are able to afford and purchase not only the basic device but also disposable products like a catheter, tubing, and tape that go along with it.

“Medtronic is already aware of our belief that that is an important item to address,” he said.

Internet of Things (IoT) Day: 3 takeaways for the healthcare supply chain

Whether we realize it or not, we’re past the age of the Internet and well into the age of the Internet of Things (IoT) in which increased, virtual communication among machines is poised to completely transform healthcare as we know it—making the industry smarter and more efficient. Thankfully so because there’s simply no more room for wasted time and money.

The scope of current inefficiency in the medical devices market, for example, is staggering. These devices alone contribute to an estimated $5 billion¹ in waste annually. There are many other sources of waste including excess inventory, product loss, expiry products, revenue leakage at the point of charge capture, and unnecessary shipping costs caused by poor inventory tracking and planning.

As you celebrate the Internet of Things Day (April 9, 2017), the implication for supply chain is simple: Waste must – and can – be eliminated. Consider these three supply chain opportunities, and how eliminating waste with an IoT approach and advanced technologies can help promote efficiency:

1. View the supply chain holistically and expansively, from sourcing to usage.
   The healthcare supply chain is no longer just about manufacturing, distributing, and transporting products. In order to properly evaluate the value chain, therefore, it must be viewed holistically, encompassing both direct and indirect costs. This caliber of system-wide valuation demands data and lots of it – data that can be collected, aggregated, visualized and acted upon.
   Key takeaway: Leverage IoT technologies to enable cloud-based, system-wide inventory management with data analytics to connect products and processes with their true cost.
2. Invest in technology to improve the “user experience” for clinical staff.
   According to a recent survey, physicians and nurses report spending nearly 20 percent of their work in a week on supply chain management tasks – like searching the store room for a specific cardiac catheter or counting the number of products used in a case. Sixty-five percent of those surveyed would trade this time to be with their patients. But with advanced product-tracking technologies, like radio frequency identification (RFID) systems, clinical documentation can be as easy as waving a product by an RFID-reader in the operating room.
   Key takeaway: Use the IoT’s connectivity and data-sharing capabilities to free the frontline staff from inventory-related burdens.
3. Adopt automated technologies to improve accuracy, speed, and spend.
   In a recent survey, supply chain leaders estimated $500,000 in annual savings using automated
   supply chain technology. Properly balancing inventory levels to match usage patterns, reducing and properly managing product expirations, freeing up capital, and reducing patient risk are just a few ways automation can improve the speed and accuracy of supply chain management. Data gleaned from IoT connectivity is also enabling proper management of consignment, accurate clinical documentation, and product and workflow standardization across entire enterprises.
   Key takeaway: The healthcare supply chain is a strategic asset that can yield large financial
   savings, and the IoT is key to propelling change.

Tech savvy and visionary hospitals and health systems are adopting this Internet of Things approach to the way they manage products and processes to reduce costs, improve efficiencies and improve the total cost of care. How can your hospital take advantage of the connectivity and efficiencies that IoT and automated technologies have to offer?

¹PNC Healthcare; GHX quantitative research study (August 2011)

About Cardinal Health Hospital Supply Chain Survey 
This study was fielded Oct. 19 - Nov. 4, 2016, using an online survey methodology. The samples were drawn from SERMO’s Online Respondent Panel of Health Care Providers, which includes over 600,000 medical professionals in the United States. The study included 403 respondents total, including frontline healthcare providers in hospitals (n=201), service line leaders in hospitals (n=100), and hospital/supply chain administrators (n=102). All survey data on file at Cardinal Health.