Navigating Insulin Delivery, Like a GPS

We already have the ability to use a global positioning system when we’re behind the wheel, not only plotting out where we are on the road but also to find out what turns to make next on the drive to wherever we’re heading.

Now, take that idea into the world of diabetes management.

Think of that GPS helping you automatically map out your insulin treatment, charting glucose readings and suggesting what doses you might need to stay on course and not veer off the road.

That is what a new diabetes device called the D-Nav aims to do. It uses what the creators call a “Diabetes Insulin Guidance System,” or DIGS, for short to act like a nav system for your car.

“Like a GPS, you tell the device where you want to go, and it creates a master plan and then adjusts the plan to your current blood-sugar levels,” said Eran Bashan, co-founder of Hygieia, Inc. “The benefit of a GPS isn’t knowing where you are, it’s knowing what to do next. We don’t see a value in glucose readings per se, but rather in what you do with the numbers.”

All of this is the brainchild of Bashan and Dr. Israel Hodish, an endocrinologist originally from Tel Aviv, who are now both at the helm of this five-year-old startup company that’s based near the University of Michigan campus where the two met close to a decade ago.

Hiya-what?

The name might seem confusing, but it’s pronounced “hy-jee-uh.” You know, like the 1^st century Greek goddess of health who was daughter to the God of Medicine. Or maybe the Bowl of Hygieia, one of the universal symbols of pharmacy. We’re guessing it’s not named after the huge asteroid, 10 Hygieia.

We’ve seen Hygieia around the diabetes scene a few times over the last few years. In fact, we introduced their work here at the ‘Mine back in 2011 via an interview with one of our VC  judges in the 2011 DiabetesMine Design Challenge. But Hygieia has mostly been under the radar until recently, when the company got European regulatory OK in October to launch their product overseas. Bashan and Hygieia Chairman of the Board Karen Drexler also attended our 2012 DiabetesMine Innovation Summit in November.

Early this year, we finally got a chance to learn more about their offering on their home turf; on a recent visit up to visit family in Michigan, I stopped by the startup’s offices located in a business incubator area on the western edge of Ann Arbor – a city saturated with innovation thanks to U-M.

From the outside, their business doesn’t look like much. Even inside where their 15 employees are stationed, the space resembles an accountant’s or lawyer’s office more than it does an ambitious med-tech business. But in talking with the company co-founders, you get a sense of how visionary they are.

Dr. Eran Bashan and Dr. Israel Hodish

Hygieia’s chief exec Eran Bashan and co-founder Israel Hodish, an endocrinologist at U-M’s Medical School who serves as the startup’s clinical advisor, are both Israeli natives who came to U-M’s engineering school in 2004. Bashan came from a military leadership role before working in engineering management developing consumer electronics at small and larger companies, while Hodish had an interest in both engineering and gene therapy that led him to endocrinology.

They got the idea for a “diabetes GPS” back in 2008. They met for dinner one night on campus and fleshed out a plan, and they launched their company in August 2008 — just two weeks before the collapse of financial giant Lehman Brothers.

Neither had a personal diabetes connection to diabetes themselves when starting this venture, but both say they now have some family members living with diabetes and injecting insulin.

But as an endo and an engineering/innovation expert, they clearly saw the need for some kind of technology to help take the insulin calculation guess-work out of D-management. The device is aimed at the growing population of PWDs with type 2 who use insulin, along with type 1s who aren’t hooked up to insulin pumps.

Hodish says an estimated 80% of type 2 PWDs won’t see an endocrinologist either because of the nationwide shortage or the higher cost than seeing a primary care doctor, and that figure is probably under- reported. The U.S. healthcare system is pushing more patients to general practitioners instead of more expensive specialists, and all of that combined is feeding the need for this type of D-device.

“We are seeing more people with type 2, and more of those diabetics are going on insulin. You need constant adjustments, and being engaged is a lot of work,” Bashan said. “Our system allows patients to adjust their insulin immediately based on what’s happening in their body, rather than wait up to 90 days to see a physician and then change their dosage.”

So What Exactly is D-Nav?

The D-Nav appears to be the first of its kind anywhere in the world. Modeled after a Blackberry, the device looks like an insulin pump at first glance with a similar-styled screen and buttons on its face. But the D-Nav doesn’t take on the task of infusing insulin into anyone. Instead, it serves as a glucometer that uses a proprietary D-Nav strip to check blood sugar just like a traditional meter.

You put a drop of blood on the strip just like any other meter, and wait for the five second countdown to tick down and show your reading. But instead of focusing on simply producing BG readings, the D-Nav goes a step beyond. It only flashes your glucose number for three seconds before the result vanishes. Then, the D-Nav calculates what your insulin intake should be based on that BG result — using pre-programmed settings by your physician. The device calculates correction, food bolus (if needed) and any other factors such as insulin on board (IOB) that might be applicable.

So for example, if someone is on two shots a day, the D-Nav displays any correction bolus that might be needed based on the time of day and its pre-programmed knowledge of when their last insulin injection might have been taken. People on basal-bolus injections multiple times a day can plug in their food amounts and the device will calculate the recommended total insulin dosage.

Once the total dose is displayed, the PWD can decide to follow or ignore it – just like any driver can rely on GPS navigation behind the wheel or choose to go another route. Of course, just like any traditional meter, insulin pump or CGM device, the D-Nav comes with software and a connection cable to upload data from the device – for the PWD to see and for the doctor’s review.

This system definitely seems unique, although it does somewhat resemble the non-U.S. version of the Abbott Freestyle InsuLinx meter, which crunches insulin-to-carb ratios and calculates recommended insulin dosages like the insulin calculators built into insulin pumps. (Remember our take on this meter?) But the D-Nav goes a lot further by analyzing glucose patterns and helping the PWD to make frequent therapy adjustments.