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Diabetes Care, Vol 11, Issue 10 808-812, Copyright © 1988 by American Diabetes Association

ARTICLES

Method for estimating confidence levels for measurements by blood glucose monitoring systems

TM Kelly, RL Jensen and MK Robinson
Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City.

A joint conference on self-monitoring of blood glucose (SMBG) has proposed that all glucose monitoring systems generate values that are within 10% of the actual blood glucose level 100% of the time. To estimate the confidence limits of blood glucose measurements made in a typical university ambulatory care setting and to ascertain whether they met the proposed standard, we performed duplicate determinations of blood glucose using a reflectance meter and applied to the measurements a method for calculating the closeness of measured values to a "true" mean. Based on paired measurements in 100 consecutive diabetic subjects, we were able to show that one measurement would be within 11.9% of a true mean value 95% of the time and within 8.4% of the mean 90% of the time. The 95 and 90% confidence limits for the average of two repeated measurements were calculated to be 8.4 and 5.9%, respectively. Our methodology can be applied to any set of SMBG values to calculate their confidence limits and to determine whether the measurements meet recommended standards.
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Copyright © 1988 by the American Diabetes Association.