Diabetes is widely known as a disease requiring a high degree of patient “self-management” to be truly effective.

But self-management is only the tip of the treatment iceberg, you might say, since it is based on a large amount of disease information, patient training and clinical monitoring of patient adherence.

And then, what if you’re a patient living on a farm or ranch 150 miles or further from a healthcare center providing such services?

That is the treatment conundrum currently being tackled by early stage firm InforMedix Holdings (Rockville, Maryland), developer of the Med-eMonitor, a portable, Internet- connected device that functions as a combined drug dispenser and electronic patient diary.

With the Med-eMonitor, “you can do things remotely that you’d have to do in a clinic,” says Bruce Kehr, MD, chairman and CEO of InforMedix.

Beyond providing improved disease management for diabetes, the Med-eMonitor can offer much increased adherence to management for all types of “high-risk, high-cost diseases,” Kehr told Medical Device Daily, and it could be an equally essential part of recruiting patients for drug trials and monitoring adherence to those trials.

To further these goals, the company has just reported a partnering effort with four organizations – the University of Pennsylvania (Philadelphia), the Leonard Davis Institute at the Wharton School of Business (also Philadelphia), McKesson BioServices (also Rockville) and St. Vincent Healthcare (Billings, Montana) – to create a program for outcomes research, disease management and clinical drug trials.

These organizations will provide combinations of funding and services and use InforMedix’s Med-eMonitor system in a program titled Disease Management and Telehealth Outcomes Research Program.

Key to this program is the Med-eMonitor, which already is being piloted with a handful of patients in rural areas of Montana, for managing diabetes, Kehr reports.

Already, he says, the company has received “very powerful testimonies from some of those patients.” And he says that one woman called the company office “in tears” – the exultant sort – saying that, “for the very first time in her life,” her diabetes was under control.

“She told us the Med-eMonitor was a godsend,” he said. “Clearly [the device] reduces the need for patients to come into the clinical site.”

While the new telehealth program using the Med-eMonitor will be deployed for patients in both suburban and rural areas – in this case, various areas of the Northeast – it is particularly helpful for remote areas, he said.

“Running a ranch or a farm, that’s a huge geographic barrier” for disease control, he noted, with other factors such as weather or perhaps subsistence-level economies thrown in to raise these barriers even higher.

With use of the Med-eMonitor in their homes, Kehr says, patients may have to see their physicians much less frequently – perhaps as much as one-third less often – and the control and monitoring it provides reduces co-morbidities, hospital stays, even death.

Though it has a variety of functions, the device’s major feature is a drug dispensing system.

Trays of the appropriate pre-packaged drugs are mailed to the patient, who then fits the tray into a slot in the device. The device then dispenses the drugs at pre-programmed intervals, providing alerts concerning the proper regimen and warnings if the patient accesses the drugs too often.

Kehr notes that the company consulted with ethicists who warned against locking out too-frequent access – recognizing the demands of daily schedules changes or travel – but he says also that the monitoring provided by the device works against over-medication.

Overall, the device’s tracking systems provide for creating database trends of glucose levels and other physiological parameters, and then the device can be remotely re-programmed to provide regimen alterations to fit changing patient needs.

“The patient interacts with the device, with it providing a variety of prompts not only concerning drug schedules but also such things as diet and exercise tips,” Kehr says.

Though not exactly intuitive, use of the device can be mastered in just 10 to 15 minutes, he notes, and the company has tracked high levels of patient satisfaction, both coming as the result of intensive field testing. It was designed primarily with seniors in mind.

“It’s pretty much like an ATM machine,” Kehr says, “only a little simpler.”

The new diabetes trial will involve 3,325 patients, with a separate trial being proposed by the company for use in dispensing medications to schizophrenia patients.

Further out, Kehr sees important uses of the Med-eMonitor in clinical trials for drugs – not just in monitoring patient compliance but also in helping to recruit patients who live in otherwise unreachable areas, and thus facilitating the speed and, importantly, reducing the costs of those trials.

The company says it believes the Med-eMonitor is positioned to make headway in the chronic disease market, putting that total opportunity at $2.5 billion to $5 billion annually, with the drug trial application at about $1 billion.

The new diabetes trial not only will measure patient outcomes but also will provide an easily tracked assessment of the financial returns resulting from its deployment, InforMedix says. In particular, the company believes that the monitor will be valuable in tracking the impact of disease-specific protocols that, when not adhered to, increase the cost of care.

“Once proven cost-effective, these disease-specific modules could be successfully marketed to CMS [the Centers for Medicare & Medicaid Services], third-party payers and self-insured corporations,” InforMedix says.

More globally, it notes the increasing demands of government compliance and the potential for the Med-eMonitor to provide this type of data.

Besides a co-branding and co-marketing alliance with McKesson BioServices, the company has an agreement with invivodata (Pittsburgh) for product marketing as part of that company’s portfolio.

InforMedix projects 2005 revenues of $2 million, with a target of $5.2 million as its break-even revenue point.