Assuring the Accuracy of Home Glucose Monitoring
Assuring the Accuracy of Home Glucose Monitoring
Background: An estimated 2.5 million diabetic patients in the United States practice self-monitoring of blood glucose (SMBG). The validity of the glucose values they obtain is in doubt. An American Diabetes Association consensus panel reported that up to 50% of SMBG determinations might vary more than 20% from their true value. Accurate glucose values are an integral part of intensive treatment and reduction of long-term complications. The objective of this study was to determine the technical skill and accuracy of SMBG in an outpatient population.
Methods: This study was conducted in two family practice residency sites where 111 patients with type 1 and type 2 adult diabetes were observed testing their blood glucose values on their own glucose monitors. Patient-measured glucose levels were immediately compared with a laboratory value obtained from a calibrated hand-held glucose monitor.
Results: Fifty-three percent of patient glucose values were within 10% of the control value, 84% were within 20% of the control value, and 16% varied 20% or more from the control value. Two patients had dangerously inaccurate glucose determinations. Four glucose monitors required replacement. The patients were observed using a 13-point checklist of critical steps in calibration and operation of their glucose monitor. Only 1 patient made no errors in testing.
Conclusions: Despite multiple technical errors when using SMBG, most patients obtained clinically useful values. This project can be easily introduced into a medical office.
Of the 16 million persons in the United States with diabetes mellitus, 300,000 patients who have type 1 diabetes and 30% to 40% of the 7 to 7.5 million patients who have type 2 diabetes are receiving insulin therapy. Most could bene t from home glucose monitoring to evaluate their response to therapy more carefully, to improve glycemic control, and to reduce the risk of hypoglycemia and microvascular complications. The actual number of home glucose monitors in use is unknown, but it is estimated that 1.0 to 2.5million patients with diabetes self-monitor their blood glucose.
A consensus panel of the American Diabetes Association (ADA) has encouraged the use of self-monitoring of blood glucose (SMBG) by those patients and caregivers who are able to learn the technique, are motivated to collect accurate results, and are willing to adjust their treatment depending on the monitored levels in consultation with their health provider. During carefully controlled conditions, hand-held glucose meters have been shown to have good correlation and acceptable clinical accuracy in determining blood glucose levels when compared with standard laboratory testing. Accuracy of glucose determinations by diabetic patients obtained in their homes is suspect, however An ADA consensus panel reported that up to 50% of SMBG determinations might vary more than 20% from the true value. It is therefore surprising that there has been no report of patients directly observed while obtaining their glucose levels. In 1997 the worldwide market for hand-held blood glucose monitors and supplies was estimated to be $2.05 billion, with a growth rate of 11% per year, an expensive price to pay for possibly inaccurate, potentially misleading, and occasionally dangerous information.
In an attempt to reduce the variation in SMBG values to less than 10% from the reference values, and to improve the appropriate use of information gained through this potentially valuable technique, the ADA recommends (1) periodic simultaneous comparisons of patients monitors with that of a reference laboratory, (2) patient education, and (3) further research toward determining those characteristics of patient-health care provider relationships that influence interactions and improve glycemic control and health outcomes. With these goals in mind, we studied the accuracy of SMBG among outpatient diabetic patients through direct observation of their techniques and comparison with a laboratory blood glucose monitor.
Background: An estimated 2.5 million diabetic patients in the United States practice self-monitoring of blood glucose (SMBG). The validity of the glucose values they obtain is in doubt. An American Diabetes Association consensus panel reported that up to 50% of SMBG determinations might vary more than 20% from their true value. Accurate glucose values are an integral part of intensive treatment and reduction of long-term complications. The objective of this study was to determine the technical skill and accuracy of SMBG in an outpatient population.
Methods: This study was conducted in two family practice residency sites where 111 patients with type 1 and type 2 adult diabetes were observed testing their blood glucose values on their own glucose monitors. Patient-measured glucose levels were immediately compared with a laboratory value obtained from a calibrated hand-held glucose monitor.
Results: Fifty-three percent of patient glucose values were within 10% of the control value, 84% were within 20% of the control value, and 16% varied 20% or more from the control value. Two patients had dangerously inaccurate glucose determinations. Four glucose monitors required replacement. The patients were observed using a 13-point checklist of critical steps in calibration and operation of their glucose monitor. Only 1 patient made no errors in testing.
Conclusions: Despite multiple technical errors when using SMBG, most patients obtained clinically useful values. This project can be easily introduced into a medical office.
Of the 16 million persons in the United States with diabetes mellitus, 300,000 patients who have type 1 diabetes and 30% to 40% of the 7 to 7.5 million patients who have type 2 diabetes are receiving insulin therapy. Most could bene t from home glucose monitoring to evaluate their response to therapy more carefully, to improve glycemic control, and to reduce the risk of hypoglycemia and microvascular complications. The actual number of home glucose monitors in use is unknown, but it is estimated that 1.0 to 2.5million patients with diabetes self-monitor their blood glucose.
A consensus panel of the American Diabetes Association (ADA) has encouraged the use of self-monitoring of blood glucose (SMBG) by those patients and caregivers who are able to learn the technique, are motivated to collect accurate results, and are willing to adjust their treatment depending on the monitored levels in consultation with their health provider. During carefully controlled conditions, hand-held glucose meters have been shown to have good correlation and acceptable clinical accuracy in determining blood glucose levels when compared with standard laboratory testing. Accuracy of glucose determinations by diabetic patients obtained in their homes is suspect, however An ADA consensus panel reported that up to 50% of SMBG determinations might vary more than 20% from the true value. It is therefore surprising that there has been no report of patients directly observed while obtaining their glucose levels. In 1997 the worldwide market for hand-held blood glucose monitors and supplies was estimated to be $2.05 billion, with a growth rate of 11% per year, an expensive price to pay for possibly inaccurate, potentially misleading, and occasionally dangerous information.
In an attempt to reduce the variation in SMBG values to less than 10% from the reference values, and to improve the appropriate use of information gained through this potentially valuable technique, the ADA recommends (1) periodic simultaneous comparisons of patients monitors with that of a reference laboratory, (2) patient education, and (3) further research toward determining those characteristics of patient-health care provider relationships that influence interactions and improve glycemic control and health outcomes. With these goals in mind, we studied the accuracy of SMBG among outpatient diabetic patients through direct observation of their techniques and comparison with a laboratory blood glucose monitor.
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