Wednesday, August 04, 2004


Glucose Document part I

Guidance Glucose Document: "Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitors are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU, CCU, OR, or other bedside locations. Used at home, these devices allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.1
Despite some problems with blood glucose monitors, a Consensus Panel of physicians, diabetes educators, and laboratorians has recommended blood glucose monitoring (BGMg) testing for insulin-treated diabetes. The Panel, sponsored by the American Diabetes Association, FDA, NIH, and CDC, stated that most of the problems with current monitoring systems involve the user and not the system itself.2 Thus, emphasis should be placed on educating users and following up on their performance. The Panel recommended that manufacturers help by developing systems with memory to allow comparison of patient's recorded meter glucose results with their laboratory glucose results and by building in quality control checks that must be performed before samples can be run.3
The primary intended use for glucose monitoring is to assist in the evaluation and management of individuals with diabetes. On November 17-19, 1986, the Consensus Panel of the American Diabetes Association recommended BGMg for the following uses:
. Pregnancy complicated by diabetes
. Individuals with a propensity for severe ketosis or hypoglycemia
. Individuals prone to hypoglycemia who may not experience the usual warning symptoms
. Individuals on intensive treatment programs, especially those using portable insulin-infusion devices and multiple daily insulin injections

. Individuals with abnormal renal glucose thresholds
The Panel indicated that although controversial, BGMg may be useful for individuals with diabetes not treated with insulin. However, the Panel cautioned that BGMg must not be used to diagnose diabetes mellitus, and the role of BGMg systems in screening remains uncertain. The Panel remained silent on the use of these systems with neonates. However, some BGMg systems have been validated for use with neonatal specimens. (See FDA's Review Criteria for Portable Glucose Monitoring Devices Intended for Bedside use in the Neonate Nursery).4

A broad spectrum of issues were identified for glucose monitoring. These include 1) intended and actual use, 2) adequacy of calibration and quality control, 3) accuracy and precision of these devices, 4) types of users, 5) training, 6) the adequacy of user instruction, and 7) procedural and technical limitations,2 8) specimen types (arterial, capillary, venous, whole blood, plasma), and 9) Hct effects. Additionally, more recent reports indicate environmental factors i.e., temperature, humidity, and altitude may also effect results.

The consensus document expressed the following performance goals: a) "The goal of all future Self Monitoring Blood Glucose (SMBG) systems should be to achieve a variability (system plus user) of 10% at glucose concentrations of 30-400 mg/dL 100% of the time. However, the panel is aware that the accuracy required for clinical management has not been rigorously defined.", b) "With current systems, SMBG measurements should be within 15% of the results of the reference measurements.", c) "Approximately 50-70% of individuals who receive some sort of formal training are capable of obtaining a result within 20% of the reference method; however, performance may deteriorate over time."

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