Why no sleek testing devices?

Diabetics must cart around bulky, noisy equipment. Technological advancement is slow, hurdles remain.

October 22, 2010|By Julie Deardorff, Tribune Newspapers

The week Apple sold its 100 millionth iPod, Amy Tenderich sat down and wrote an open letter to the company's chief executive, Steve Jobs.

Tenderich, then 37 and a newly diagnosed Type 1 diabetic, was frustrated that medical devices weren't as subtle and slick as portable music players. "Most of (our) devices are clunky, make weird alarm sounds, are hard to use and burn quickly through batteries," she wrote on her blog, diabetesmine.com. "Their design doesn't hold a candle to the iPod."

Jobs has yet to respond. But Tenderich's 2007 letter generated a buzz in the industry and ultimately launched a contest to help revolutionize the design of diabetes devices for the nation's 24 million diabetics. In its third year, the Web-based competition garners more than 150 entries from around the world, offers $23,000 in cash prizes and has been credited with lighting a fire under the medical-device industry.

"We follow Diabetes Mine and the other big diabetes blogs, and when the design request came out, we watched with earnest," said John Mastrototaro, vice president of research and development at Medtronic, which introduced the first continuous glucose monitoring product in 1999. "Some of the ideas have a lot of merit."

Current devices

Diabetics have high blood glucose levels. Their bodies either don't make enough insulin to regulate blood sugar or don't use the insulin as well as it should, causing sugar to build up in the blood.

Equipment: Today's insulin-dependent diabetics often use two fundamental pieces of equipment: the insulin pump, which allows them to get insulin whenever they need it, and a continuous glucose monitoring system, which lets them see whether their blood sugar is too high or too low.

Extras: The disease requires hauling an extensive amount of extra gear beyond pumps and monitors, including test strips, lancets and emergency sugar. The pumps, meanwhile, which are programmed to automatically dispense insulin, are the size of a cell phone and worn outside the body. The bulge — and the beeping noise it makes — can draw unwanted attention and get in the way of daily activities.

Dream devices

Steve Malchow, 49, who was diagnosed with Type 1 diabetes when he was 6, calls his insulin pump a "life changer." It has reduced the number of shots he takes from 21 a week to 2. Malchow, of Ankeny, Iowa, would now like to see improved technology to monitor blood sugar: Instead of pricking his finger several times a day to monitor his glucose level, he'd like to see a device that can read through the skin. (Researchers in Japan announced this month that they have designed tiny beads that detect blood sugar levels when implanted in the ears of mice, and they hope to eventually use this to replace more invasive techniques for people with diabetes.)

Other diabetics dream about the prototype that won the 2009 Diabetes Mine contest: a hardware and software system for iPhones that combines a lancet, test strips, glucose meter, wireless insulin pump management and disease-management software all in one package.

The modified iPhone carrying case could hold the lancet device and a box to store testing strips, said Samantha Katz, who designed the LifeCase and LifeApp system with Eric Schickli while both were graduate students at Northwestern University.

They also designed an iPhone app to test blood sugar as if checking e-mail or a text message. "Combining different supplies into one device makes it less obvious you're using an insulin delivery system," said Katz, 28, who is now a global product manager for Medtronic.

Recently, Sanofi-Aventis rolled out what has been called the most streamlined solution to date — a blood glucose meter that plugs into an iPhone.

But while the idea of integrating a medical device into a smart phone has taken hold, the biggest hurdle is the Food and Drug Administration, which is just starting to look into how to regulate phones that double as medical devices.

FDA approval is one reason why the LifeCase and LifeApp system is currently shelved; meanwhile, the FDA hasn't yet cleared Sanofi-Aventis's product, the "iBGStar," which works as a standalone meter when not plugged into the iPhone or iTouch.

Still, Tenderich is optimistic. Her goal with the contest wasn't necessarily to get the products to the market; instead, she wanted to get the industry's attention and help the next generation of designers and thinkers — people such as Katz — get placed in jobs where they can make a difference.

Medtronic, for example, is working to make products simpler to use or wear, Mastrototaro said.

"Medical devices will be integrated with smart phones," Tenderich said. "But will it happen a year from now or nine? If we can accelerate that we'll have accomplished something."