Magazine article Drug Topics

New Glucose Monitor Spares Patients from Fingersticks

Magazine article Drug Topics

New Glucose Monitor Spares Patients from Fingersticks

Article excerpt

Without question, the self-- monitoring of blood glucose (SMBG) has revolutionized the management of diabetes. But frequent finger-prick testing can be painful and inconvenient, leading many patients to test only twice a day, which results in suboptimum treatment.

Now by year's end, diabetes patients will have a painless way to monitor their blood glucose levels that will address both reduced finger sticks and the need for additional glucose data. Cygnus Inc. of Redwood City, Calif., will offer diabetes patients a novel, autonomic, noninvasive glucose-monitoring system-The GlucoWatch Biographer.

The Food & Drug Administration approved the wristwatch-like device, which will be available only by prescription, to detect trends and track patterns in glucose levels in adults 18 years and older. Patients usually perform SMBG before meals, at bedtime, and occasionally during the night to guide therapy. However, the latest evidence shows a link between postprandial hyperglycemia and many of the major complications of diabetes including retinopathy, nephropathy, and cardiovascular disease.

The GlucoWatch system consists of two main parts: the GlucoWatch Biographer and the AutoSensor. The Biographer is worn like a watch and calculates, displays, and stores glucose readings. The AutoSensor is a single-use component that works by extracting a tiny portion of glucose from the skin, using extremely low electric current, which is then converted into a glucose reading.

The company's medical director, Robert Eastman, spoke about how this new technology differs from conventional blood glucose monitoring devices. Most significantly, it is noninvasive, measuring glucose collected through the skin, not from blood. It provides automatic glucose levels every 20 minutes for up to 12 hours. The GlucoWatch can store up to 4,000 values and allows users to set personal glucose alert levels (too low or too high).

Eastman emphasized that the GlucoWatch system is a supplemental tool and is not intended to replace standard home glucose monitoring devices. In fact, the user must use a home blood glucose meter to calibrate the GlucoWatch with each new AutoSensor and to confirm the Biographer readings in certain circumstances (e.g., insulin adjustments).

The FDA noted that in clinical trials conducted by Cygnus, the "GlucoWatch measurements generally were consistent with the results from traditional finger-prick blood tests." However, up to 25% of the time, the results differed by more than 30%. Eastman explained that part of this variation is due to lag time in that each Biographer reading corresponds to a blood glucose value from about 15 minutes earher, yielding an average value rather than an instantaneous one. …

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