Makers of glucose meters and other personal medical devices are developing products that communicate with customers who have an Apple iPhone , Research in Motion BlackBerry or another "smart phone."

Patients with diabetes, hypertension and other chronic conditions are downloading software applications that can help them manage their day-to-day treatment regimes.

Medical device makers have multidisciplinary teams working on new applications, examining long-term business models and determining whether they can strengthen customer loyalty with a presence on different mobile platforms.

LifeScan recently demonstrated a prototype application for the new Apple iPhone OS 3.0 operating platform that allows its glucose meters to send glucose readings to an iPhone through wireless BlueTooth communications technology or over a 30-pin connector cable.

Other features on the prototype application would allow a diabetic teenager, for example, to calculate the level of carbohydrates in her lunch and plan her insulin dose accordingly, as well as send a message to her parents letting them know she was up to date on her treatment.

"It generated a lot of excitement," said Dave Detmers, director of communications for LifeScan. But the demonstration was merely meant to show what is possible on the mobile platform, and LifeScan has no imminent plans for a commercial launch.

"There is more work that has to be done in terms of defining a product and matching that to patient and health care professional needs, and obviously doing the appropriate development work and then getting the appropriate clearances and then launching," Detmers said. "We don't have a timeframe for that."

The company will probably have to consult FDA at some stage, because the agency has authority over some health care software applications, depending on their intended use. Glucose management software for a hand-held device or one sold with that software loaded onto it could be regulated by FDA as a medical device (¹ Also see "Not Sure If Software Is A Device? It’s All About Intended Use, FDA Says" - Medtech Insight, 27 April, 2009., p. 7).

Detmers noted that LifeScan already has PC-based software platforms for diabetics, including the OneTouch Zoom that transfers data from a glucose meter through a computer cable.

The software can organize patients' data and present it in charts and graphs to show them how they are doing relative to goals they have set with their doctors, Detmers explained.

Detmers would not speculate on how long it might take for mobile phone applications to go through the FDA process.

Before the software goes to FDA, the company plans to hone and refine its features through input from customers and health care professionals.

LifeScan wants to bring diabetes management solutions to as many people as possible, but is currently focused on the most popular devices.

"Clearly, mobile devices are becoming very ubiquitous," Detmers said. "Apple devices are certainly very popular, so the idea is to fish where the fish are."

Detmers said that no decisions have been made on whether LifeScan's iPhone software application would be interoperable with competing glucose meters, but exclusivity may be an option that helps build loyalty.

A primary benefit to having glucose meters interact directly with a mobile phone application is that patients would no longer have to manually enter data from their glucose meter, which is both more convenient and accurate than manually entering the data, Detmers said.

"You are dealing with medical information that you're using to calculate dosage of medication, to make decisions about carbohydrate intake, to [create] record-keeping that you share with your health care professional, so it's really important that you're not adding to people's burdens and introducing the potential for error," he added.

In addition to price, simplicity will be very important in driving adoption of medical device applications that interact with mobile phones, said Peter Wagemann, executive director of the mHealth Institute.

He said that in order to keep data secure, some systems require users to log in and enter a password every time an application is accessed, then change the password every few weeks, inhibiting usage.

DexCom has a "very active project" devoted to finding ways for its Seven Plus continuous glucose monitors to wirelessly communicate with other portable devices, according to CEO Terry Gregg.

Gregg thinks that in the earliest stages of the market, "it's going to be that relatively small group of technically adept patients that will migrate to those types of devices."

Payment And Reimbursement Issues

Insurers might view upgrading to a wireless glucose monitoring technology only as an improvement in convenience for the patient, Gregg said, "and in today's health care environment, third-party payer systems do not pay for convenience."

But if device makers can provide an economic justification for the upgrades, such as increased patient compliance that leads to improved outcomes, third-party payers may be willing to consider the more expensive technology, he predicts.

Payers will insist on rigorous studies to demonstrate that the more expensive technology improves patient outcomes, Gregg said.

Those studies would enroll many patients and be expensive to complete, so it is unlikely that any single device maker would fund such studies on its own and let its competitors gain from a change in reimbursement policy. Instead, the companies will have to collaborate to prove the cost-effectiveness of the technology.

"We all recognize that there is better safety in numbers if we were all willing to participate in those types of studies."

Individual patients will also be sensitive to price, according to Gregg. Diabetes test strips and syringes are usually a significant out-of-pocket cost for patients. If an upgrade to a new glucose meter cost $100, a lot of patients would probably be willing to pay for the upgrade, Gregg speculated, but "if they have to pay $500, then it would be a fraction of the patients who would be willing to utilize that technology and pay for it out of pocket."

Wagemann said that when insurance companies give incentives to beneficiaries to adopt medical applications on mobile phones, "it's never the full reimbursement; it's always just a part of it to encourage people to use such systems."

He thinks patients will be willing to pay extra for medical devices that can interact with their mobile phones, especially those patients who are middle aged or younger and some who are very sick.

A few payers and home health care agencies are looking at ways to use smart phones to help manage high-risk patients with chronic health conditions, according to Fraser Edward, Manager, Market Development - Health Care for Research In Motion.

Edward said that insurance companies in Canada and the U.S. have pilot projects exploring the medical benefits of using smart phones to track patients. "The conversations are starting in the big insurance companies," Edward said.

Creating the market for mobile phone applications that interact with medical devices may pose a challenge, Edward said, but the launch of the BlackBerry App World on April 1 and the earlier launch of the iPhone App Store could help.

Edward said that he and other smart phone users tend to get "addicted to going to see what other apps I can pull down and what other things I can get" from the wireless apps stores. "There is definitely an appetite for capabilities on these smart phones that are really part of our day-to-day life."

"This dramatically opens up the marketplace for the self-pay model," Edward said.

Some Apps Pre-Date MedTech Interactivity

Sensei Inc. recently introduced its My Diabetes Guide for diabetics or pre-diabetics with iPhones. The company did not need FDA clearance for the product because it does not monitor medical data, said CEO Bob Schwarzberg.

That may change if the company partners with diabetes device makers to transfer data over BlueTooth technology.

According to Schwarzberg, Sensei is addressing challenges such as data encryption and HIPPA compliance.

Schwarzberg said that in partnering with a glucose monitor maker, it would be important for Sensei to find a top brand name that has good distribution for its test strips and other necessary disposables.

"The meter itself is not necessarily what makes it convenient for people, but also how they get their supplies," Schwarzberg said.

That said, Sensei does not need to partner exclusively with a single glucose monitor manufacturer. "I would prefer that we accommodate the popular models, and therefore have as broad an audience as possible," Sensei's CEO said.

Developers Look To Interoperable Standards

According to DexCom's Gregg, the current BlueTooth technology "is massively power consumption driven," which is one reason the company plans to wait for a new generation of wireless connectivity technology before it launches an application for a mobile handset such as iPhone or BlackBerry.

Otherwise, he noted, the required transmitter would be twice the size of those used in the company's current devices that can currently communicate with other portable diabetes products on the market, such as the Animas insulin pump.

In DexCom focus groups, the company found that increasing the size of the glucose monitor would be unacceptable, "since we have the smallest footprint of the [continuous glucose monitor] companies today, and [that is] one of our selling advantages."

Gregg expects most major glucose monitor companies will adopt an ultra low power BlueTooth technology currently in development within the next year or two.

- Monica Hogan (m.hogan@elsevier.com)

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