Tiny, accurate and easy to use, the FreeStyle Lite ranks highly among runner-up blood glucose monitors in reviews. Like the top-rated Bayer Contour (*Est. $20), the FreeStyle Lite reads test-strip codes automatically (you don't have to enter them by hand), holds several hundred test results in its memory and allows several alternate test sites (palm, forearm, thigh, upper arm and calf) besides fingertips. Unlike the Bayer Contour, the FreeStyle Lite boasts a backlit screen and test-port light for easier testing at night, and it requires an even tinier pinprick of blood (0.3 microliters versus 0.6 microliters). The FreeStyle Lite is also one of the smallest glucose meters on the market. Although it proves accurate in one test (closely matching lab-test results), the FreeStyle Lite isn't as consistent (repeating identical results from identical samples) as the Bayer Contour and some other brands. Another drawback is the cost of the FreeStyle Lite's test strips. At $30 for 50, they cost more than strips for the Bayer Contour or the top-rated budget meter, the ReliOn Micro (*Est. $9).
Until recently, the FreeStyle Lite used a type of test strip that can't read correctly in the presence of some sugar-containing drugs and therapies (such as a certain type of kidney dialysis solution), but in 2010 FreeStyle Lite switched to a different type of strip that doesn't have that problem.
Also in 2010, the U.S. Food and Drug Administration (FDA) issued a warning to Abbott Diabetes Care (maker of the FreeStyle Lite) after inspectors found problems with its manufacturing process. Specifically, the Food and Drug Administration said Abbott didn't follow correct quality-control procedures in some cases (such as when scratches were found on FreeStyle Lite test strips), and some Abbott managers didn't have the proper education or experience. Abbott issued a statement that it "has taken and continues to take the actions necessary to address the items outlined in the letter and is communicating those actions directly to the agency." As of this update, the FDA had not issued a close-out letter indicating that Abbott had fixed the problems.
ConsumerReports.org asks volunteers to test the FreeStyle Lite and other glucose meters for ease of use. An article at Men's Health magazine refers to another Consumer Reports review that also tests consistency and accuracy. ChildrenWithDiabetes.com chooses the simplest glucose meters for kids to use, and Amazon.com posts user reviews for the FreeStyle Lite. We found information about the new FreeStyle Lite test strips at Abbott Diabetes Care's website and information about an FDA warning letter to Abbott on the FDA site and The Wall Street Journal's website.
The FreeStyle Lite is one of 15 blood glucose meters tested for ease of use at ConsumerReports.org. Editors also note the meters' annual strip cost and how long they take to test, then rank the meters from best to worst. Only subscribers can access ratings, but the site includes some general information for nonsubscribers.
Review: Blood-Glucose Meters, Editors of ConsumerReports.org, Dec. 2009
2. Men's Health
This article refers to another Consumer Reports test of blood glucose meters with ratings for accuracy and consistency as well as ease of use. The FreeStyle Lite rates excellent for accuracy and very good for ease of use, but only fair for consistency.
Review: The 10 Best Blood-Glucose Meters, Editors of Men's Health
The FreeStyle Lite is one of the easiest blood glucose monitors for children to use, according to this educational organization. This full review evaluates all key features and rates the meter on six measures (such as speed and cost) and overall.
Review: FreeStyle Lite, Editors of ChildrenWithDiabetes.com, Sept. 22, 2007
Averaging 4 stars out of 5 in a dozen user reviews, the FreeStyle Lite is one of the highest-rated glucose meters at Amazon.com. Users appreciate its small, discreet size and say it's easy to use.
Review: FreeStyle Lite Blood Glucose Monitoring System, Contributors to Amazon.com
5. Abbott Diabetes Care
Abbott announced its new FreeStyle Lite test strips in May 2010. The strips no longer use the GDH-PQQ enzyme, so sugar-containing drugs no longer pose any interference problems. The new strips replaced the old style in the U.S. market in August 2010.
Review: Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite Test Strips, Abbott Diabetes Care, May 24, 2010
6. U.S. Food and Drug Administration
This warning letter outlines violations that FDA inspectors found during inspections in 2010.
Review: Abbott Diabetes Care, Inc. 7/2/10, FDA District Director Barbara J. Cassens, July 2, 2010
7. U.S. Food and Drug Administration
Here, the FDA posts close-out letters, indicating that companies have fixed the problems outlined in warning letters. No close-out letter had been posted for Abbott Laboratories' July 2, 2010, warning letter as of this update.
Review: 2010 Warning Letters, Editors of U.S. Food and Drug Administration
8. The Wall Street Journal
The Wall Street Journal posts a short report on the FDA's warning letter to Abbott Diabetes Care. In it, the company states that it has addressed the FDA's concerns about its manufacturing procedures.
Review: FDA Sends Warning to Abbott Diabetes Unit, Jennifer Corbett Dooren, July 20, 2010