FDA Panel Reviews Alternate Site Blood Glucose Monitoring
The Clinical Chemistry and Clinical Toxicology Devices Panel Meeting of the FDA was held on October 29, 2001 in Gaithersburg, Maryland. The committee was charged with providing advice and recommendations on the types of data and/or labeling needed in 510(k) submissions for glucose test systems to address problems associated with using blood samples from alternate sites, such as the forearm, upper arm, thigh, calf, or base of the thumb.
The Panel was asked by the FDA to consider the following questions. Comments and recommendations are presented directly after each question.
- Should FDA's review of these devices include dynamic as well as steady state data, or are there more appropriate and less burdensome ways to address this public health issue?
Response: The Panel was concerned about evidence that consistently showed that a lag time exists between the measurements shown in finger capillary blood vs. alternative site capillary blood when blood glucose is rapidly changing. This would mean that someone whose blood glucose was dropping into the hypoglycemic range might not see this change in alternative site testing immediately, and thus might not be able to act appropriately upon the impending hypoglycemic episode. The Panel voiced strong opinion that, because most of the testing to date had only been provided in "steady state" situations (i.e., conditions in which the subject's blood sugar was very controlled and stable), dynamic testing was, indeed, the next step. Several panel members commented that type 1 diabetes is a dynamic disease and that children with type 1 are rarely in any kind of "steady state." The dynamic situations suggested included studying the effects of alternative site testing (AST) following exercise, AST in sick day management, AST in individuals taking a variety of medications, and AST in different pediatric groups to assess the effects of age and growth.
- Should FDA require manufacturers to include strong cautionary labeling about this problem unless they provide data demonstrating that the discordance is unlikely to occur with their particular device?
Response: Yes, all companies who manufacture alternative site testing meters need to include cautionary labeling.
- Should FDA:
- Rescind the clearance for labeling for alternative site testing if the 510(k)s do not address this new scientific issue?
- Make these products prescription home-use?
Response: The Panel had differing opinions, but ultimately decided that they would not recommend prescriptions be needed for home use.
- Require additional data and labeling changes?
Response: This is not needed beyond what is already required in the cautionary labeling. Additional changes may be needed based upon the findings of future dynamic studies.
Are there other activities or issues that FDA should consider with regard to this important public health issue, such as:
- A public health alert(the Panel was divided, but ultimately "no")
- Targeted postmarket surveillance(yes, as in the dynamic studies for specific populations mentioned above)
- Educational outreach activities to stakeholders and other government and non-government entities to promote additional research in this area?(yes)
The Panel cautioned the FDA "not to move backward" with regard to AST. They stated that it was an important tool in diabetes management and represented a great stride forward. They acknowledged that alternative site testing for most people is far less painful than finger sticks and therefore increases the likelihood that they will test more often and thus have better information for better control of the diabetes.
They also cautioned that "Diabetes is just not what the book says," that people with diabetes are individuals with individual reactions, and that every person considering alternative site testing should work with their diabetes team to determine if AST is safe for them to use and under what circumstances. There clearly are situations in which AST should not be used, and a fingerstick should be used instead. These include:
- Sick day management
- In a person with hypoglycemic unawareness
- In any situation in which a dropping blood glucose might be expected (i.e., after exercise)
- Whenever a person feels their blood glucose is low.
Various companies that manufacture blood glucose meters, including some that use alternative site testing, presented testimony at the hearings. Companies represented included Amira Medical; Abbott Laboratories/Medisense Products; LifeScan, Inc.; TheraSense, Inc.;, Cygnus, Inc.; and Roche Diagnostics Corporation.
During the Open Public Hearing, families from Children with Diabetes were represented by Laura Billetdeaux and her 11 year old son, Sam. Clare Rosenfeld, a CWD teen and also the ADA's National Youth Advocate 2000, shared her comments as well. Sonia Cooper, president of the Children with Diabetes Foundation, sent comments on behalf of the Foundation to the Board, and these were read aloud to the Panel. Over 30 letters and email submissions from CWD families were sent to the Panel and were noted in the proceedings.
Background information, including the agenda from the meeting and questions for the committee, can be found at Clinical Chemistry and Clinical Toxicology Devices Panel. Also see CDRH Background Package.
Posted November 3, 2001
Last Updated: Thursday August 29, 2002 20:59:48
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