Home Test for Diabetes Control
The Gist: The FDA has approved a home test kit for the blood level of
glycated hemoglobin to help monitor the blood levels of
sugar over the past 3-4 months, as opposed to the usual blood tests that only
provide a reading of the blood sugar level at that one point in time.
Comment: As a diabetic, I now have blood drawn every 3-4 months at my doctor's office
and sent to a lab to test for glycated hemoglobin. I think I'll be buying this new test kit soon.
For more, please visit the following MedicineNet.com areas:
Barbara K. Hecht,
Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com
FDA CLEARS HOME GLYCATED HEMOGLOBIN TEST FOR DIABETICS
The Food and Drug Administration (FDA) has cleared the first over-the-counter
test that measures glycated hemoglobin in people with diabetes to help monitor
how well they are managing their disease (glycemic control).
The test, called Metrika A1c Now, is currently available by prescription
only. Over-the-counter status means that the test can now be purchased without a
prescription and used at home, with results on the spot, making it readily
available to people with diabetes.
Diabetes is a chronic disease in which blood glucose (sugar) levels are too
high. Abnormally high levels of glucose can damage the small and large blood
vessels, leading to blindness, kidney disease, amputation of limbs, stroke, and
heart disease.
Glycated hemoglobin is a unique substance created as a result of interaction
between hemoglobin and glucose.
The level of glycated hemoglobin provides information on the average level of
glucose in the body over a 90 to 120 day period of time.
The glycated hemoglobin test should be performed two to four times a year to
monitor long-term control over blood glucose levels. Glycated hemoglobin tests
provide information to complement that obtained from daily finger stick blood
glucose tests that measure glucose at a single point in time.
To perform the Metrika A1c Now test, the patient takes a blood sample from
his finger with a lancet and places it in a monitor. The monitor displays test
results in eight minutes. Unlike some other products, there is no need to send
the sample back to the physician to get results. The patient gets the results on
the spot.
FDA cleared the test for non-prescription use based on a clinical study
conducted by the manufacturer, Metrika, Inc., of Sunnyvale, Calif. The study
compared test results obtained by lay users of the device to test results
obtained by medical professionals. In the study, 286 patients-271 diabetics and
15 non-diabetics-used the test without physician supervision.
The results were comparable to those obtained by medical professionals.
The Metrika A1c Now test has been certified by the National Glycohemoglobin
Standardization Program, an independent certification body.
About 17 million Americans have diabetes. Many of them may find the new home
glycated hemoglobin test helpful.
Source: FDA Talk Paper # T02-55, December 17, 2002 (www.fda.gov)
Last Editorial Review: 12/18/2002
Diabetes RSS