Blood Glucose Monitor App Gains FDA Approval

Emma Hitt, PhD

Disclosures

May 15, 2012

May 15, 2012 — The iBGStar blood glucose monitor for iPhone and iPod touch, manufactured by Sanofi Diabetes, has now gained clearance by the US Food and Drug Administration, making it the first blood glucose meter that directly connects to the iPhone and iPod touch.

The company announced last week that the iBGStar Blood Glucose Monitoring System, consisting of the iBGStar blood glucose meter and iBGStar Diabetes Manager App, would be available in the United States. It had already been available in the United Kingdom.

According to the company, the iBGStar system consists of a glucose monitor that attaches to an iPhone or iPod Touch via the 30-pin dock connector. The app is designed to track glucose, insulin, and carbohydrates, and it charts individualized glucose patterns over time. Data can be emailed to healthcare professionals as needed.

Information collected and displayed by the device includes a trend chart, which shows a graph plotting glucose readings and gives a visual representation of blood glucose levels over time; a logbook, which provides a detailed record of glucose readings, organized by meal relationship tags for each reading; statistics, which offer preset average glucose results for a period of 7, 14, 30, or 90 days or a customized date range; and alerts, which provide color-coded hypo and hyper alerts when blood glucose readings are out of range.

The device is compatible with the second-, third-, and fourth-generation iPod Touch and the iPhone 3G, 3GS, and 4.

A prescription is not required for purchase of the device, but is often needed for coverage by a patient's individual insurance provider. BGStar Blood Glucose Test Strips may also need to be prescribed.

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