The week of September 14, 2014

For diabetics, a long wait for a wearable solution

By Allen Weiner

I was at Disney World in 1998 when I found out I was diabetic. The “happiest place on Earth” indeed.

The test, know as an HA1c, is rarely wrong. My result was off the charts and my life would be changed forever. Real Coke and M&Ms were replaced by a low glycemic diet, pills, and exercise. A few years later, the routine became pills and injections, and in 2005, an insulin pump entered my life. A device that resembles a streamlined pager with a number of doohickeys attached (including one stuck in my abdomen), the pump is actually an ecosystem that includes a number of icky (but useful) parts that results in continuous insulin delivery.

While I wouldn’t have labeled it such originally, my pump really was my first “wearable”—an electronic device I wear to make my life easier. But while it has improved my ability to deal with diabetes, this wearable is not a flashy talking piece. It makes things like sleeping, exercising and dressing up for high-level business meetings difficult. We won’t discuss the limitations a pump offers for romantic encounters.

Over the years, some bespoke designs, fashioned for me by my wife, made my wearable fit into my life more easily. One such accessory, which my wife and I endearingly call “The Puppet,” attaches to my bedshirt via two safety pins. This crocheted sleeve, with two pockets, holds my pump while I sleep and has a 99 percent success rate of keeping my glucose management system, Animas One Touch Ping, in place through the night. The second pocket was geared to hold a Continuous Glucose Monitor (CGM), which will set off an alarm should my levels go dangerously low. Cool-looking? Not at all. Life-enhancing? Absolutely.


It’s not like I had other options. Generally when medical devices, high-tech design, and fashion intersect, those of us who depend on our wearables for better health are left with partial solutions and empty promises. The complexity of devising a transparent, elegant solution that allows a diabetic to test blood glucose levels and have precise amounts of insulin delivered to the body requires the left brain of Louis Pasteur and the right brain of Sir Jony Ive.

Because of this, I’ve been anticipating Apple’s smartwatch for months. This week I sat excitedly watching Apple’s launch event for what I would learn to be named the Apple Watch. Rumors were swirling that it would do everything from tell time to predict the winner of the first race at Hialeah. In the diabetic community, there was chatter about its ability to measure blood glucose levels, which seemed valid given Apple has hired staff from the now-defunct diabetes company in California known as C8 MediSensors. C8 had received European approval for its noninvasive, optical CGM (continuous glucose monitoring) technology, which would be a welcome feature for the 25.8 million diabetics in the U.S.

Cool-looking? Not at all. Life-enhancing? Absolutely.

After an elegant but self-serving video presentation from Sir Jony aimed at Apple fanboys, we learned that beyond health and fitness applications, there was nothing mentioned related to the Apple Watch that would help those with chronic illnesses. Prior to the event, many sources believed that the Mayo Clinic would be on stage with Cook and company to show how Apple’s HealthKit framework would create the link between patient, personal medical data and health care providers. Mayo’s nonperformance at the Apple event is one indication that perhaps the Cupertino, Calif.-based megapower is not far enough along on the path to create medical wearables to go public. Apple may also be working with the FDA for approval, which can be a long and arduous process.

Either way, the Apple Watch as we know it today won’t help me manage my diabetes more than a Fitbit could.

Those of us in search of wearables that look as cool as the new Apple Watch will have to be patient until its early 2015 launch. Or perhaps look elsewhere for a beautiful silver bullet.

Do pump manufacturers have the answer?

Turning a medical wearable into a fashion accessory seemingly has Project Unicorn (even for Apple) written all over it—but why? More than 300,000 diabetic patients worldwide use an insulin pump for therapy. How many more would be willing to use this wearable if it maintained the same therapeutic benefits but looked more like an iDevice and less like a pager? Given that many health insurance carriers pay for pump therapy—since tighter control over diabetes can cut the risk of later complications—it seems that highly influential business would be in favor of such an evolution.

Ramakrishna Venugopalan, Ph.D., MBA, heads research and development (R&D) for Animas, a division of Johnson & Johnson that manufactures insulin pumps and related supplies. He wants to marry elegance and performance to meet the expectations of consumers bombarded with a dizzying array of futuristic gadgets. “Pump users expect a similar touch and feel as their other consumer products,” Venugopalan told The Kernel.

We won’t discuss the limitations a pump offers for romantic encounters.

Venugopalan explains that an insulin pump is an unusual wearable in that it’s termed a “consumer-directed medical device.” While it’s prescribed by a physician and built under careful FDA guidelines, the pump is managed by the user on a day-to-day basis. To be effective, a pump requires careful handling including filling and refilling the insulin cartridge, changing the site where the insulin is subconsciously delivered, and even changing the battery. At this point in its design life cycle, Venugopalan says, function plays a larger part than form in development.

“Our goal is to give everyone a good outcome,” he says. “We cannot compromise for other asks.”

Also at issue is the variety of pump users and their technical skill levels. As Venugopalan remarked, “Pump therapy is not a democratic therapy.” For every user like myself who is somewhat adept at regulating settings, there is an elderly patient who struggles with even the most basic functions. In this no-one-size-fits-all scenario, my desire for a pump that looks like a Rolex but acts like an artificial pancreas may be beyond the scope of today’s wearables.

Mike Hill is senior director for product marketing at Medtronic, a company whose diabetes management business (pumps and other therapies) brings in $1.7 billion annually. He believes the vision of merging simplicity and flexibility with tight control is what patients want, and he believes manufacturers are up to the challenge.

“Our mental model five years ago was that technology was intimidating,” Hill says. “Society’s expectations have changed, and we welcome that expectation that it can be done.”

The Apple Watch as we know it today won’t help me manage my diabetes more than a Fitbit could.

One such vision, shared by Medtronic, Animas, and others, falls under the concept of creation of an artificial pancreas. While the build out of such a device varies from company to company, it is a closed-loop or semiclosed-loop system that incorporates BG testing, insulin calculation, and delivery in one device or two connected devices. And in one test, that device administering dosing information was a smartphone.

Smartphones and the apps that run on them offer some benefit for diabetics, but only in rare cases—such as those in clinical trials—do they transform the pump into a discrete or high-fashion wearable. Even the Omnipod, a self-contained insulin delivery device, requires a proprietary, wireless meter that acts as glucometer and dosing instrument. As Apple showed in its smartwatch unveiling, smartphone apps for diabetics—pump wearers and non-pump wearers alike—present the ability to input vital stats such as heart rate, track fitness regimens, or even help create optimal diet plans.

The Internet of everything, but…

I am a big fan of the time-honored yet half-baked philosophy that states: “If they can put a man on the moon, then…” The quixotic hope for a fashionable wearable that improves life for those of us with a chronic illness is powered by the current bright light given to the old-but-new concept of the Internet of Things. Everything is or can be connected; pick up your phone, glance at your watch, and the magic of the Internet can connect your desires to a device, and your wants and needs can be delivered.

To date, those creating medical devices, or innovators wanting to tap into the lucrative Internet of Things hardware and software market, have lacked the vision to fully understand the potential of a connected universe. Apple’s vision for a seamless connection between people and things may provide the medical device industry the impetus and inspiration to move more quickly and for the FDA to move to the side of the angels.

In the meantime, I have my wife crocheting more pump wearables in a rainbow of colors.

Illustration by J. Longo