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Monday, December 24, 2018

Pump It Up: Diabetes Technologies Continue to Revolutionize Care


As devices become smarter and smarter and improve patient outcomes, they also pose challenges for patient and clinician education. While clinicians ensure all patients are up-to-speed on the new technology, a new threat looms: Keeping data safe. 
In an early episode of the CBS crime drama Elementary, a man is found dead of an apparent heart attack. But Sherlock Holmes deduces that it is a case of murder — the victim’s pacemaker was hacked.
More than one Agatha Christie novel involves an unsuspecting victim succumbing to an insulin injection.
With diabetes patients now using continuous glucose monitors (CGMs) connected to insulin pumps via smart phones, could Dr. Evil combine these two plots and hack the pump’s insulin delivery to commit murder most foul?
That apocalyptic vision may already be possible, some experts say, but it contrasts with a very positive real-world example related by a diabetes specialist: A type 2 diabetes patient over 80 years old was at his vacation home in Arizona when he passed out during a hypoglycemic episode. His wife was out of the house and without her phone. But when his CGM detected his perilously low blood sugar level, it caused an alarm to sound on his daughter’s smart phone in Portland, Ore. She called the neighbors in Arizona, who found her father unresponsive and dialed 911. The first responders revived him.

Fast-Changing Technology

These wildly disparate scenarios illustrate the promise and the peril of new technologies that are rapidly improving the lives of many diabetes patients. CGMs and insulin pumps are becoming smaller, more accurate, and easier to use “off the shelf,” with less need for patient or clinician intervention. Some CGMs are so reliable that they don’t require calibration by the patient. One commercially available “hybrid closed-loop system” of a CGM interacting with a pump is nearing the goal of an artificial pancreas, while some tech savvy patients are already using do-it-yourself systems. Even insulin pens are becoming smart enough to communicate with phones to deliver the correct amount of insulin.
It used to be that a patient would visit an endocrinologist every three or four months so the physician could adjust the treatment. But the new technologies “put the patient in the driver’s seat and put decision-making tools in their hands to tweak their treatment,” says Dennis Harris, PhD, associate editor of content strategy and outcomes at the Endocrine Society — and an early adopter of technology as a type 1 diabetes patient himself.
“I see amazing successes, but the vast majority of those successes are people who are familiar with using technical tools,” Peters says. “I’ve had patients whom I have literally forbidden to wear sensors because they overreact so much to changes in their glucose.” – Anne Peters, MD, director, clinical diabetes program; professor, clinical medicine, Keck School of Medicine, University of Southern California, Los Angeles
But there are concerns that those who could benefit the most from the technology could be the last to get it. “I work in Beverly Hills, in a practice where people have health insurance and are really well educated, and they are incredibly avid adopters of technology,” says Anne Peters, MD, director of the clinical diabetes program and professor of clinical medicine at the Keck School of Medicine at the University of Southern California. “I also work in East Los Angeles where people are of lower socioeconomic status. Many have fifth grade reading levels and don’t speak English as a primary language. Their ability to adopt and use technology is much, much less. And, of course, it is much more needed because lower income patients have much poorer outcomes.”
Better teaching tools are needed to reach these patients, and groups like the American Association of Diabetes Educators are working on creating them, including multilingual instructions. Funded by a grant from the Helmsley Charitable Trust, Peters has created free online tools for less literate patients in English and Spanish (available at http://uscdiabetes.com/#pens).
Seniors are another subset particularly at risk because “they are more prone to hypoglycemia and more prone to the adverse outcomes from hypoglycemia, such as falls and fractures,” says Andrew Ahmann, MD, professor of medicine and director of the Harold Schnitzer Diabetes Health Center at Oregon Health and Science University in Portland.
Peters agrees: “Even seniors who are more educated are much less comfortable with technology, they are not people who wander around with smart phones.” Plus, issues of cognitive decline must be taken into account.
“If seniors are exposed to and carefully taught how to use technology, they get by their concerns,” Ahmann says. “But you have to approach them a little bit differently. You have to get them to persist in its use long enough that they can get by those initial anxieties and uncertainties. I think the manufacturers are doing a good job of making their products simpler and simpler.”

The Conundrum of Shared Data

Ahmann says that he has been “surprised at how many patients, when they have the opportunity to share their information, are choosing not to. Or don’t even want to put it on their phone and prefer to use a much simpler receiver.”
But Ahmann can attest to the benefits of sharing. One family insisted that their 80-something father share his information, and the move paid off when he passed out on his large rural property — and a family member used the iPhone finder app to locate his unconscious body and get medical help.

Sharing with Physicians

By using smart phones, patients can tie into databases and algorithms that can help with their insulin dosing and also share their data with their physicians. Peters’ patients’ data is uploaded automatically, with no need for action by the patient, to a platform called Tidepool — open source software for a variety of devices distributed by a nonprofit organization. Jessica Castle, MD, an associate professor of medicine at Oregon Health and Science University, accesses her patients’ data via several software systems, including Glooko (broadly compatible commercial software), Medtronic’s CareLink, and Dexcom’s Clarity. She says the Dexcom system is particularly handy because “once people accept the request to share data from a device with our clinic, I can access it without them doing anything further, which is really nice, because one of the barriers for being able to review data is for patients to have to download information from their devices.”
She finds these systems particularly helpful for doing a weekly review of CGM and pump data from pregnant women with type 1 diabetes.

Issues of Cybersecurity

Of course, the use of cell phones and cloud computing to receive and share data raises questions of hacking and cybersecurity, issues beyond the control of clinicians and patients and left in the hands of the manufacturers of the devices. To guide manufacturers in making safer devices, the Diabetes Technology Society has developed a pair of cybersecurity standards, according to David Klonoff, MD, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, Calif., who chaired the standards development committee.
The first standard, called DTSec, is for information going to or from a connected diabetes device, such as a handheld, dedicated controller. The second standard, called DTMoSt, “is intended to help manufacturers understand what types of security features are needed when you have a mobile phone controlling a device — a situation so new that there is not even a product on the market yet that would need it,” Klonoff says.
“If you want to find out how to do anything, you go to YouTube. But the extension to medical applications must be done cautiously. We will have the challenges of separating out the ones that are done very professionally and scientifically from those done by self-appointed experts.” – Andrew Ahmann, MD, professor of medicine and director, Harold Schnitzer Diabetes Health Center, Oregon Health and Science University, Portland
“If you give enough people enough time and enough equipment they can hack into anything,” Klonoff says. “So the idea isn’t for a medical device to be absolutely unhackable, because that is impossible. But there are levels of difficulty for hacking in. We have set a fairly high level because it is related to a medical product.” For a device to be certified as meeting the standard, it is sent to a lab that does “penetration testing” to see how hard it is to hack. “One company has already had products verified as meeting DTsec,” Klonoff says.
“I think at some point, patients are going to start demanding that products meet DTsec or DTMoSt, but right now, most patients don’t know about it,” Klonoff says.

Can Coverage Keep Up?

These kinds of standards may make it easier to get new devices approved for coverage by payers.
But payers are not always keeping up with the technology. For example, it took several years and concerted efforts by groups like the Endocrine Society working with the manufacturers to get Medicare to provide coverage for glucose monitors like the Dexcom G5 and the Abbott FreeStyle Libre Flash Glucose Monitoring System. But it was many months later that Medicare agreed to extend coverage to the use of smart phones. And although the Food and Drug Administration has approved the next step in the Dexcom family — the G6, which provides an upgrade over the previous model because it does not require calibration — one might think that it would be an easy process to receive Medicare approval as well. But Medicare has yet to act.

Education Everywhere

Education — for payers, patients, and physicians — is a key to effective adoption of the new technologies.
“I see amazing successes, but the vast majority of those successes are people who are familiar with using technical tools,” Peters says. “I’ve had patients whom I have literally forbidden to wear sensors because they overreact so much to changes in their glucose.”
The landscape is changing so fast that even clinicians have a hard time keeping up with it — and knowing how to teach their patients about it.
Ahmann says that professional societies are working on this problem, and the internet could be a key help: “YouTube is potentially going to be a significant player in patient education. If you want to find out how to do anything, you go to YouTube. But the extension to medical applications must be done cautiously. We will have the challenges of separating out the ones that are done very professionally and scientifically from those done by self-appointed experts.”

— Seaborg is a freelance writer based in Charlottesville, Va. He wrote about Medicare approving some CGMs for coverage in the September issue.

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