Replacing guesswork in diabetes screening
The number of people with diabetes is increasing rapidly. Screening and early detection have the potential to save lives and avoid severe complications. However, success in screening for or diagnosing diabetes depends on accurate glucose measurements.
Glucose measurement at the point-of-care
Today, the majority of point-of-care devices for measuring blood glucose are so-called glucose strip meters. These were originally developed for the self-monitoring of glucose levels in people already diagnosed with diabetes, but now they are also used extensively in hospitals and primary care settings.
The International Organization for Standardization (ISO), in its quality specifications for instruments used in the self-monitoring of glucose, has suggested that 95% (2 SD) of measurements should be within ±20% when compared to a laboratory method. This is the norm for glucose strip meters and is considered good enough for the self-monitoring of glucose at home. But what is the impact of such inaccuracy when screening for or diagnosing diabetes?
Consider a case involving a fasting patient with a true plasma blood glucose level of 7.0 mmol/L (126 mg/dL). Measuring with a strip meter with a potential error of ±20% will result in reported values being somewhere in the range of 5.6–8.4 mmol/L (101–151 mg/dL). As a result, the risk of misclassification will be very high.
"Recommendation: There are no published data to support a role for portable meters in the diagnosis of diabetes or for population screening. The imprecision of meters, coupled with the substantial differences among meters, precludes their use in the diagnosis of diabetes and limits their usefulness in screening for diabetes."
Sacks et al. Guidelines and Recommen-dations for laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus. Clinical Chemistry
2002; 48: 436-472.
Another way for health care providers to obtain glucose results is to send the patient or sample to a lab. Sending the patient involves practical concerns for caregiver and patient alike, while sending the sample involves a pre-analytical concern in the form of glycolysis. Red blood cells, platelets and white blood cells present in the sample will continue to consume glucose, and by the time the sample reaches the lab and is analyzed, the glucose level may have decreased significantly.
The only certain way to avoid glycolysis is to analyze the sample immediately.
Sending samples to a lab involves
- Risk of clerical errors
- Extra paperwork
- Errors due to glycolysis
- Patient callbacks
- Prolonged anxiety for the patient
The HemoCue® advantage
HemoCue® Glucose 201 avoid these problems and make it possible to achieve successful screening and diagnosis at the point of care. The systems are for professional use and are cleared by the U.S. Food and Drug Administration (FDA) not only for monitoring, but also for diagnosis.
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