FDA Clears PositiveID’s iglucose, A Wireless Communication Diabetes Management System


The U.S. Food and Drug Administration (FDA) granted PositiveID Corporation clearance for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.

For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators (AADE) positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.

The iglucose system eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition. iglucose uses mobile technology to seamlessly communicate blood glucose readings from an individual’s data-capable glucometer to the iglucose diabetes management portal, where, with the user’s consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax. iglucose does not require the use of a cell phone or a wireless plan.

The iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The company is continually adding to this list of supported glucose meters.

PositiveID surveyed healthcare professionals at the AADE annual conference regarding the company’s iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.

The company believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada, and will look to add additional wireless partners.

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