FDA Clearance of Diabetes Devices

Tandem Diabetes announced that they received clearance of their t:slimTM Insulin delivery System on November 16th, 2011. This device is the first insulin delivery system with a full touch screen interface and is now the smallest insulin pump to reach the market. This device is a full featured insulin pump with an improved user interface making this device easy to operate, and also contains a micro pumping system which allows it to accept a 300 unit cartridge while becoming the smallest and slimmest insulin pump on the market.

Sanofi-Aventis U.S. together with its partner AgaMatrix announced that the FDA granted 510(k) premarket clearance for the iBGStarTM Blood Glucose Monitoring System, the first and only FDA cleared blood glucose meter that directly connects to the Apple® iPhone® and iPod touch®, seamlessly integrating accurate blood glucose monitoring into the lifestyles of people with diabetes.


http://www.tandemdiabetes.com/News/FDA-Clearance-of-the-t-slimTM-Insulin-Delivery-System/ and http://sanofi.mediaroom.com/index.php?s=64&item=57

Ramifications for Individuals with Type 1 Diabetes:

The clearance of the Tandem Diabetes Care t:slimTM Insulin Delivery System provides users with the modern convenience of a touch screen interface in a compact insulin pump. The use of a touch screen allows Tandem to provide an intuitive interface for users, creating labels, buttons, and distinct shapes, guiding the user through the functions of the device. It also provides a modern look and feel that more resembles a consumer product, providing some discretion when interfacing with the pump. The patented micro pumping technology allows Tandem to package all the needed functionality into a compact form factor, and also provides the flexibility of expansion into multi-hormone pumping configurations without sacrificing size.

The clearance of the Sanofi-Aventis iBGStarTM Blood Glucose Monitoring System provides users with the ability to measure blood glucose with a proven blood glucose meter technology by AgaMatrix, while interfacing with a consumer hand held communication device, the Apple® iPhone® (and iPod touch®). The connectivity to the iPhone® provides the user with the ability to seamlessly utilize blood glucose information in glucose data programs, communicate to parents and caregivers, and store the data for later use. Prior to the iBGStarTM, users would have to measure their blood glucose and enter the glucose level, date, and time manually into a journal application. This product simplifies the process, and makes the blood glucose meter look more like a consumer device than a medical device, providing some discretion when using the device.

JDRF Involvement:

JDRF was not involved in the development or approval of either device.