Tiny, accurate and easy to use, the FreeStyle Lite blood glucose meter's illuminated screen and test strip port make it particularly good for testing at night. The FreeStyle Lite doesn't require manual coding, holds 400 test results in memory, and allows several alternate test sites (palm, forearm, thigh, upper arm and calf). It requires a small, 0.3 microliter sample and returns test results in 5 seconds.
Right on the mark, more often than not. The FreeStyle Lite requires a smaller-than-usual 0.3 microliter test sample, which makes a lot of users happy: "I really enjoy not having sore fingers," writes one reviewer at Walmart.com. It returns results in 5 seconds but, more importantly, draws excellent scores for accuracy and repeatability from a leading consumer research organization. These are backed up by several clinical trials that ranked the FreeStyle Lite as one of the most accurate -- and consistent -- glucose meters evaluated.
Glows in the dark -- sort of. The FreeStyle Lite's most notable features are its backlit display screen and the illuminated test strip port. Users say the light isn't strong, but it's enough to help you test your blood sugar at night. Otherwise, the FreeStyle Lite comes with the expected collection of features: memory for 400 date- and time-stamped readings, the ability to calculate 7- 14- and 30-day averages, and four programmable reminder alarms. It comes with a carry case and you can download the readings to Abbott Diabetes Care's free, PC-compatible CoPilot Health Management System software, although you need a special data cable to do it.
Draws user raves. Although there are -- as always -- a few outlying complaints, the FreeStyle Lite draws consistently positive user reviews for its convenience and ease of use; it also gets a "very good" convenience rating from a leading consumer research group. It doesn't require manual coding and beeps to let you know you've applied enough blood to the test strip. If you don't get enough blood the first time, you can apply more blood for up to 60 seconds -- a major plus if you struggle with the testing process. A few wish they could apply their blood at the end of the test strip, though, instead of along the side near the corners.
On the pricey side. A leading consumer research organization estimates the yearly cost of using the FreeStyle Lite at about $1,750, assuming that you test your blood four times a day. We gauge the on-the-ground price of its test strips at $35 for 50, although the manufacturer offers a copay program that can limit your cost to about $15 per 50 strips if you qualify.
It's worth noting that Abbott Diabetes Care (maker of the FreeStyle Lite) received an FDA warning in July of 2010 after inspectors found problems with its manufacturing process. As of March 2014 the FDA has not posted a closeout letter to indicate that it had inspected again and determined the issue to be resolved, although Abbott claims to have resolved the issue in a July 20 article published in the Wall Street Journal.
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1. Journal of Diabetes Science and Technology
The FreeStyle Lite aces this test of 43 blood glucose meters as to whether they conform to current and draft ISO standards for CE-labeled glucometers; 100 percent of its tests fall within the acceptable accuracy limits.
Review: System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose According to DIN EN ISO 15197, Guido Freckmann, M.D., et al., September 2012
2. Journal of Diabetes Science and Technology
This test evaluates the variability between test strip lots for five glucometers; researchers evaluated four lots of test strips for each meter. The FreeStyle Lite is one of only two meters that meet the criteria in DIN EN ISO 15197:2003 with each lot of test strips tested.
Review: Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose According to ISO 15197, Annette Baumstark, Ph.D., et al., September 2012
The FreeStyle Lite is one of 25 blood glucose meters tested by ConsumerReports.org. Editors note factors including each meter's accuracy and convenience, and the cost of a year's worth of test strips. Only subscribers can access ratings, but the site includes some general information for non-subscribers.
Review: Blood Glucose Meter Ratings, Editors of ConsumerReports.org, Not dated
4. Diabetes Technology & Therapeutics
In this test of five recently introduced blood glucose meters under everyday conditions, the FreeStyle Lite shows the lowest mean absolute relative difference in readings. (We note that Abbott Diabetes Care, which manufactures the FreeStyle models, was involved in the design and analysis of the tests.)
Review: Accuracy Evaluation of Five Blood Glucose Monitoring Systems Obtained from the Pharmacy: A European Multicenter Study With 453 Subjects, Cornelius Tack, M.D., et al., April 2012
Averaging 4 stars out of 5 possible after nearly 50 user reviews, the FreeStyle Lite's Amazon.com rating has improved from 3.5 stars two years ago. Although it draws some older, mixed reviews about accuracy and problematic test strips, most of the recent complaints are about the company that sells this product on Amazon.com, rather than relating to the product itself.
Review: FreeStyle Lite Blood Glucose Monitoring System, Contributors to Amazon.com, As of March 2014
About 68 Amazon.com users give the FreeStyle Lite a 4.4-star rating out of 5 in this second listing on Amazon.com. The general consensus is that the FreeStyle Lite is very easy to use and handle.
Review: FreeStyle Lite Blood Glucose Monitoring System Diabetic Meter Kit, Contributors to Amazon.com, As of March 2014
Just around 13 Walmart.com reviewers give the FreeStyle Lite kit an average rating of 4.5 stars out of 5, making it one of the two most popular meters on this retail website.
Review: FreeStyle Lite System Kit, Contributors to Walmart.com, As of March 2014
8. U.S. Food and Drug Administration
This warning letter outlines violations that FDA inspectors found during inspections in 2010. As of March 2014, no closeout letter (indicating that the company has fixed its problem in the FDA's evaluation) has been issued for the original warning.
Review: Abbott Diabetes Care, Inc. 7/2/10, FDA District Director Barbara J. Cassens, July 2, 2010
9. 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