NOTE: FDA is reminding people with diabetes to use only the test strips that are recommended for use with their glucose meter. FDA is aware of instances where incorrect results were obtained when brands and models of meters and test strips were not used in proper combination. You can report events to MedWatch, the FDA's voluntary reporting program, at http://www.fda.gov/Safety/MedWatch/default.htm.
November is National Diabetes Awareness Month, an opportunity to raise awareness about this serious disease.
Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Q: How does FDA define “children”?
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
Using a glucose meter to monitor blood sugar is a daily part of life for millions of Americans. Glucose meters are usually small battery-operated devices, which make it convenient for people to check their glucose levels anywhere. Most work by "reading" a drop of blood the user has placed on a disposable test strip.
To begin testing, users place the test strip into a slot in the meter, prick a fingertip and then place a drop of blood onto the strip. Before pricking the skin, the user should clean the selected testing site to ensure it is free of sugar residues. If the site is not clean, the readings may not be accurate.
In a short time, the meter will show a result in its digital display window. Users record their test results and talk with their health care provider to help with overall disease management. Users may also test control materials to ensure that the meter and test strip are working correctly.
FDA reviews all glucose meters and test strips before they can be marketed to the public. The agency also requires that manufacturers demonstrate that their test system provides acceptable accuracy and consistency of results.
Recently, we have seen the emergence of advanced glucose meters that include features such as download capabilities that allow the transfer of test results to a home computer. Some meters can now test blood taken not from the fingertips, but from "alternate sites" such as the forearm and palm.
Tips for Proper Use
Read instructions carefully. Glucose meters and test strips must come with instructions for use. Your user manual should also include a toll-free phone number that you can use to contact the manufacturer. How often you use your glucose meter, and the results you should expect, should be based on the recommendations of your health care provider.
Use the test strips that are recommended for your glucose meter. It is important to only use the test strips that are specified for your glucose meter. Otherwise, the device may fail to give results or may generate inaccurate results.
Know that readings taken from "alternate sites" may not always be as accurate as readings from the fingertips. These readings can differ at times when glucose levels are changing rapidly. This is common after a meal, after taking insulin, during exercise, or when you are ill or under stress.