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[IP] Seeing the bar for Blood Glucose Meter Performance

Posted on January 9, 2014 by FDA Voice
By: Courtney Lias

 Courtney Lias is Director of the Division of Chemistry and Toxicology Devices
within the Office of In Vitro Diagnostics and Radiological Devices at FDAbs
Center for Devices and Radiological HealthMany of the nearly 19 million
Americans diagnosed with diabetes must monitor their blood glucose (sugar)
frequently throughout the day using an at-home meter to make sure that their
blood glucose is within a safe range. The ability to measure blood glucose at
home has given people with this serious and chronic condition the ability to
better control their blood sugar and thus avoid potential complications.

 In the last 10 years there has been much advancement in the development of
glucose meters. They are now smaller, require a smaller blood sample for each
test and produce faster results. However, their accuracy has improved little.

 At FDAbs public meeting in March 2010 on this topic, the clinical and patient
communities challenged the agency to improve performance of glucose meters.
Feedback gathered from that meeting directly informed the creation of two draft
guidance documents released this week. These documents set forth
recommendations, which are justified to help ensure that these important devices
are designed to be more accurate and reliable for the patients who need them. To
address this need, this week we are proposing new recommendations for labeling,
meter performance evaluation, manufacturing controls, and cleaning and
disinfection procedures to help improve the accuracy and performance of blood
glucose meters.

 FDA recognized the need to optimize the safe use of blood glucose meters in two
distinct settings: self-monitoring using devices purchased over-the-counter, and
use in a clinical setting by health care professionals. FDA believes that by
distinguishing where these devices are used, they can be better designed to meet
the needs of their intended populations and ensure greater safety and efficacy.

 Historically, devices used in these two settings have been studied using the
same methods and standards. However, it has become increasingly clear that
meters used in these different settings have unique characteristics and
different design specifications. For example, critically ill patients in health
care settings may have physiological variables, like abnormal oxygen levels,
that could interfere with the accuracy of the blood glucose meter. Patients who
use over-the-counter glucose meters and test strips at home vary in age, how
much they know about how to use blood glucose tests, and other critical factors
that might affect the accurate use of the device.

 To distinguish between FDA recommendations for blood glucose meters used in
health-care facilities, and those intended for self-monitoring by lay-persons,
the agency is issuing separate draft guidances for each one, that is:

 prescription-use blood glucose meters, for use in point-of-care professional
health-care settings, and
 blood glucose devices purchased over-the-counter, intended for self-monitoring
by lay-persons.
 We believe that these recommendations will help ensure that glucose meters meet
critical standards for accuracy in the hands of people with diabetes, who rely
on them to manage their disease. Please help us in this effort by providing
specific comments to these draft guidance documents to let us know if you agree
with our recommendations or whether you have suggestions to further improve

 Improving the quality of blood glucose meters will not solve all challenges for
those who live with diabetes, but it may help millions of people to avoid
complications and better achieve their health goals

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