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The following update has been shamelessly copied from the Integrated Diabetes Services March 2011 Newsletter – sign up at www.integrateddiabetes.com
CGM Technology Update
Medtronic Diabetes provided a demonstration of its new Enlite Continuous Glucose Monitoring Sensor at the 4th International Conference on Advanced Technologies and Treatments for Diabetes in London last month.
The “Enlite” sensor, which appears to offer some major advantages over the current “Sof-Sensor”, isn’t on the market yet but is expected to be available in the U.S. in the next 12-18 months. Enlite is designed for six-day use, compared to the current three-day sensor.
The Enlite sensor requires a much smaller (10.5 mm) and thinner (27-gauge) introducer needle, a 90-degree insertion, and a simpler automated inserter that hides the needle completely during insertion. Preliminary data also indicates better overall accuracy, particularly in the hypoglycemic range.
Bayer is also getting ready to enter the CGM market. The company presented its preliminary CGM product, which features a receiver that resembles the currently available Contour USB blood glucose meter. It comes with a built-in Contour glucose meter and a built-in USB port with pre-installed software for convenient data upload (similar to the Contour USB meter). Bayer’s sensor has a seven-day life (similar to Dexcom), oneminute data updates (similar to Navigator), a 10-foot receiver range (also similar to Navigator), and twice-daily calibration (similar to Dexcom and Medtronic). The gauge of the sensor looks to be very small (31-gauge at its widest point). The receiver/display guides the user through the various steps of the sensor insertion process. Look for Bayer’s CGM to be available in the States within the next couple of years. –ST
Dexcom is in the process of bringing a fourth-generation sensor to market (the
current Seven Plus is the company’s third-generation product). Reports indicate that
the fourth-generation sensor will be more accurate than the SEVEN PLUS (including
25% better accuracy in the hypoglycemic range), be 50% smaller, have a significantly
stronger sensor wire (eliminating the risk of possible breakage under the skin), and
have a startup time of one hour rather than two. Dexcom plans to start clinical trials
in the first half of 2011, and the company is hoping to receive FDA approval before
the end of the year.
Meanwhile, Dexcom continues in its quest to integrate with the OmniPod PDM and
Animas insulin pump. However, in the fall, the FDA requested additional data before
approving these products, causing a delay in their timelines. The Animas/Dexcom
integrated pump/CGM, which will use Dexcom’s fourth-generation sensor, will follow approval of the new sensor. Both the fourth-generation sensor and the pump/CGM combinations are already undergoing regulatory review in Europe, where Dexcom and Animas anticipate that they will be available by mid- 2011.
The combined Dexcom CGM/Insulet Omnipod PDM may take a bit longer. Insulet will likely wait until their smaller next-generation OmniPod (and new accompanying PDM) are available and then resubmit the Dexcom/PDM integration for approval, which would probably not receive FDA clearance until after the middle of 2012.
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