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How accurate must noninvasive blood glucose meters measure to get a sales approval?

For further information read :

Comment on the meeting of the FDA Committee on invasive and non-invasive blood glucose meters, for the analysis done for home blood glucose self-monitoring -March 20. and 21. 1997- kindly reported to me by Mr. Bob Rosenthal Futrex Company.

On March 20 and 21  in 1997, the devices in the fields of Clinical Chemistry and Clinical Toxicology (science of poisons) competent committee of the FDA met for a two-day meeting.

The purpose of this meeting was to speak about aspects which affect blood glucose meters for blood glucose self-monitoring.

The said committee was composed also of experts who do not work for the FDA. For example, there were 7 doctors of medicine, of which the most are directly related to various aspects of diabetic care and treatment of diabetes.

There also took part 3 experts for Clinical Chemistry in the meeting, which are responsible for laboratory analysis in the hospital. There responsibility includes the analysis of blood glucose. In addition, also  a representative of the industry and a representative of the consuming part .
attended the meeting.

At the beginning of the meeting a number of targets have been set by the FDA. It was hoped the committee would be able to identify ways that would lead to these objectives.

It was discussed as follows:

* Should the current FDA - Method for the authorization of systems for blood glucose self-monitoring be changed?

* Why is obtained
a much poorer accuracy of blood glucose self-monitoring, then when the accuracy is tested  by independent outsiders,  than that which is delivered by the manufacturers in their 510 (K) approval requests (request that a company must provide to be able to sell medical device).

* The devices for blood glucose self-monitoring in principle are used in 3 different occasions, for example at home, in the doctor's office, and in the clinic. This raises the question of whether the FDA should establish different admission policies, depending on what conditions the device is used later.

*Should the FDA establish very specific guidelines for the admission of blood glucose meters for blood glucose self-monitoring, and if so, how should these guidelines look like?

* Should for noninvasive blood glucose monitoring devices be provided the same requirements to the accuracy, and used the same admission policies as they are used  for blood glucose meters with blood from the fingertip?

Unfortunately, the number and difficulty of the questions was almost overwhelming, and therefore did not bring about a final determination of the issues at stake in the situation. But there were visible during the presentation of manufacturers of blood glucose meters a lot of interesting details.

This protocol provides a summary of the information, with particular emphasis was placed on how individual statements impact in terms of non-invasive blood glucose meters, respectively.

The current generation of blood glucose meters with blood from the fingertip for blood glucose self-monitoring.

One can distinguish two types of patients in which blood glucose meters for blood sugar control are used.

* Metabolic Stable patients - These are mainly patients  at home or in the primary care setting, thay are not in an emergency or exceptional situation.

* Metabolic Unstable patients - These are patients who are in a hospital emergency room or in the intensive care unit.

It was expressed that the current blood glucose monitoring devices could possibly not provide accurate measurements in metabolically labile patients. There were two reasons mentioned.

* Low hematocrit level. The instruments currently used do not provide accurate readings when the hematocrit level is low. In metabolically stable patients the hematocrit level is typically between 40 and 45%. In metabolically labile patients however the hematocrit level may be much deeper. This low hematocrit values ​​in blood glucose meters with blood from the fingertip lead to erroneous results which are of importance for the metabolic control of the patient.

* Deep, systolic blood pressure. The blood glucose meters currently used measure may not be correct if the systolic blood pressure is below 80 mm Hg. In this blood pressure region the blood is substantially in the central part of the human body and only a limited amount reaches the capillaries. This causes measurement errors.

In addition to the above, a limitation of the accuracy of the measuring instruments currently in use may also still be found under the following conditions.

* At high altitude (reduced oxygen content of the air)

* If the humidity is high.

* In newborns.

How accurate need blood glucose meters for blood glucose self-monitoring to be?

* In 1986, the American Diabetic Association published guidelines for the admission of blood glucose meters for blood glucose self-monitoring. Thereafter, the deviation from the laboratory value within the measurement range of
1,7 mmol/l. to 22,2 mmol/l.
(30 to 400 mg / dL) should not be more than 10%.

* In 1993, the ADA introduced new requirements for accuracy. These apply to all instruments that are to be brought onto the market. Thereafter, the maximum deviation from the laboratory value may be as low as 5%.

However, one admitted that the presently already on the market old instruments should continue to be sold at the old accuracy requirements of 1986 .

In 1987 Clarke, Cox and other developed the unique "Error Grid Analysis"  (Diabetes Care 1987 10: 622-628) This "Error Grid analysis" showed the presence of so-called fault zones within which a possible error would not have an impact to the quality of treatment of diabetic patients. (For example at a blood glucose level of
3,9 mmol/l.(70 mg / dl) or greater a accuracy, with a maximum deviation of 20% deviation from the laboratory for glucose would be quite acceptable.

The "Error Grid Analysis" also defined ranges within which a measurement error can not be accepted because this error would be detrimental in this area on the quality of care of diabetic patients.

* A recent study carried out the most glucometers for blood glucose self-monitoring showed that 20% of all measurements were not lying within a maximum deviation of plus or minus 15% of the laboratory value.

The most important point in this context, however, was called by Dr. Gutmann by the FDA and Dr. Ratner, who represents the Juvenile Diabetes Federation (association of juvenile diabetes).

They both showed that it was found in screening for diabetes treatment (DCCT) that intensive blood glucose self-monitoring and a matched diabetes treatment could prevent serious diabetes complications such as blindness, loss of kidney function or other serious complications by up to 70%. These studies were performed over a period of 10 years as a long-term study. The most important in this context statement that was made by two speakers was the following:

In the long-term study (DCCT) blood glucose meters were used, which were older than one or even two generations as blood glucose meters currently used with blood from the fingertip. It was in these instruments, for example, still needed to wipe the blood just after 90 seconds from the test strip. These old instruments reached a lower accuracy than the devices currently available.

Despite these limitations, revealed in the course of  the long-term study (DCCT),  improvements in the health of diabetics
were clearly visible, when the blood glucose value was measured often.

The above notes by Dr. Gutman and Dr. Ratner clearly show that in reality it just is not necessary to achieve the
accuracycurrently recommended by the ADA  of 5% in order to avoid the serious complications of diabetes.

Use by patients compared to laboratory application.

A detailed discussion on the topic: use of blood glucose monitoring, blood glucose self-monitoring, use of blood glucose monitoring in hospitals and doctors' offices. For the vast majority of diabetics this diskusson is likely to be of minor importance.

It is of course necessary that a device that is used in the laboratory measures as accurately as possible. The laboratory use, however, in comparison to self-monitoring is rather the exception. It is estimated that over 95% even 99% of all blood glucose meters
may be used for blood glucose self-monitoring in the household. We call this type of application, where the diabetic monitors its blood sugar itself  a clinical application of the meter, in contrast to the laboratory application.

The only reason to demand unfounded high accuracy in laboratory blood glucose monitoring for diabetes self-control because these devices are also used by a few in the laboratory of a hospital, would cause serious economic problems and unnecessarily provoke further problems.

Non-invasive blood glucose meters.

The Biocontrol Company explained how high in their opinion should be, the performance requirements to non-invasive blood glucose meters.

It has been demonstrated that it is unrealistic to assume that the first generation of injury-free blood glucose meters should achieve the same level of accuracy as the current blood glucose meters with blood extraction, or the even more stringent accuracy requirements recommended by the ADA in 1995 .

It was made clear that if such stringent accuracy requirements would be required by the FDA, the non-invasive measurement of blood glucsoe could not bea realized. At least not in the foreseeable future. It was argued, that for the community of diabetics this would be cause great suffering.

Source: Comments on FDA Panel Meeting on Invasive and Non-Invasive Glucose Meters Home.

With kind Regards
                       Hugo R. Vogel
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Disclaimer: This page serves to highlight opportunities how to get a life with diabetes under control. If you are looking for medical advice, please consult your doctor or pharmacist.

© Hugo R. Vogel all rights reserved worldwide.