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Diagnose Diabetes and Manage At-Risk Patients with In-Office Testing

The Proven Technology You Trust. Now for Diagnosing Diabetes.

Reagents

The role of hemoglobin A1c (HbA1c) testing in the management of diabetic patients is established. More recently, the medical community has recognized its clinical utility in the disease’s diagnosis. In 2009, several major associations, including the IDF, ADA, and EASD, were part of an International Expert Committee that accepted the A1c test for diabetes diagnosis. In September 2012, the intended use for Siemens DCA® HbA1c test kit1 was expanded to include new utility as an aid to diagnose diabetes and identify patients at risk for developing the disease.

 

Learn more about putting this powerful tool to work in your practice by clicking the boxes below.

The Expert Committees' decision was based, in part, on several advantages HbA1c testing offers when compared with the current acceptable methods of measuring glucose concentrations by fasting plasma glucose (FPG) or timed oral glucose tolerance tests (OGTT). FPG and OGTT require patients to either fast or inject a glucose beverage and have serial blood draws over three hours. Rather than relying on a single or episodic measurement of glucose levels, the HbA1c measurement represents a degree of glucose exposure over time and is more useful in guiding patient management and therapy adjustment. It is standardized and aligned to the DCCT/UKPDS study, exhibits less biologic variability and preanalytic instability, and is relatively unaffected by acute (e.g., stress or illness related) fluctuations in glucose levels2.

 

Independent clinical studies have shown that in-office HbA1c testing improves diabetes patient outcomes3,4,5. Availability of results at the time of visit provides healthcare providers and educators the opportunity to have meaningful, face-to-face discussions regarding treatment options. From a convenience and scheduling standpoint, it eliminates multiple visits for pre-visit blood draws or post-testing follow-up consultation.

Clinical guidelines suggest that diabetes can be diagnosed when HbA1c values are greater than or equal to 6.5%2 (48 mmol/mol). According to the American Diabetes Association (ADA), HbA1c values between 5.7 and 6.4% (39 mmol/mol to 46 mmol/mol) may identify individuals with high risk for future diabetes, a state that may be referred to as prediabetes.2

 

Individuals with prediabetes can be counseled about effective strategies to reduce the risk of developing the disease, such as making lifestyle adjustments including healthier diet and increased physical activity or drug therapy. Clinical guidelines suggest that HbA1c testing for patients with prediabetes be conducted annually.2 The DCA HbA1c test is a perfect tool for not only identifying these patients but also monitoring the HbA1c level to make sure they get to—and stay—in the safe range. Since the kit requires only a small (1 µL) whole blood sample with no need for patient fasting or dietary preparation, clinicians can quickly identify at-risk patients, review test results, and discuss early intervention and disease management options—right during the office visit.

When using HbA1c levels to diagnose and monitor diabetes, test precision provides confidence that fluctuations in reported results are most likely due to change in patient status and not test method variation. The DCA HbA1c test has demonstrated the tight precision necessary when tracking a patient’s HbA1c status and making treatment decisions over time:

 

  • An in-house study using clinical samples was conducted across three DCA Vantage® analyzers using three different kit lots. The results demonstrated very tight precision, shown by the coefficient of variation (CV)6
 HbA1c Level%CV
    5.0%1.76%
     6.5%1.73%
 8.0%2.02%
  • CAP proficiency survey results are published bi-annually at www.ngsp.org. In the December 2012 report, CV ranged from 2.6% to 2.8% across all target HbA1c levels tested, based on results reported by more than 300 DCA system users.


The Siemens DCA HbA1c test has been used for monitoring diabetes patients’ HbA1c levels since 1991, and its effectiveness is documented in more than 140 publications.

DCA HbA1c testing streamlines and simplifies patient testing in environments ranging from the physician’s office to hospitals and clinics:

  • Simple, finger-stick test with small 1 uL sample size minimizes patient discomfort.
  • Immediate results in just 6 minutes helps healthcare professionals recommend a treatment plan during patient visit.
  • No need for fasting or dietary changes before testing as compared to FPG method.
  • More convenient that OGTT, which requires patient ingestion of glucose drink with multiple blood draws over a three-hour period.

Diabetes is a growing epidemic. In 2012, it was estimated7 that 371 million people globally were living with diabetes. Of these, half were undiagnosed.

 

People with diabetes are at a greater risk of developing cardiovascular diseases such as heart attack and stroke if the disease is left undiagnosed or poorly controlled. They also have elevated risks for sight loss, limb neuropathy due to damage to the nerves and blood vessels, and renal failure requiring dialysis or transplantation.

 

Type 2 accounts for 85-90% of all diabetes cases and is largely preventable. A number of risk factors, such as overweight and obesity and physical inactivity are modifiable, and can also help reduce the complications that are associated with diabetes.

1 Not all product offerings are available in all countries. Not available for sale in the U.S./Kit #: 10698915.

2 Standards of Medical Care in Diabetes - DIABETES CARE, VOLUME 35, SUPPLEMENT 7, 1. January 2012.

3 Thaler LM, Ziemer DC, Gallina DL, et al. Diabetes in urban African-Americans. XVII. Availability of rapid HbA1c measurements enhances clinical decision-making. Diabetes Care. 1999;22:1415-1421.

4 Miller CD, Barned CS, Phillips LS, et al. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care. 2003;26:1158-1163.

5 Cagliero E, Levina DV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in Type 1 and insulin-treated Type 2 diabetic patients. Diabetes Care. 1999;22:1785-1789.

6 DCA Systems Hemoglobin A1c Addendum to Instructions for Use. 10698776 Rev A, 2012-08.

7 International Diabetes Federation. IDF Diabetes Atlas Fifth Edition. Available at: http://www.idf.org/diabetesatlas/europe. Accessed 8/2/12.

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