U.S. Pharmacist

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Nonprescription HbA1c Monitor for Home Use

Adrienne L. Travis, PharmD candidate,
Florida A&M University College of Pharmacy, Tallahassee

Chiaju D. Ukegbu, PharmD candidate,
Florida A&M University College of Pharmacy, Tallahassee

Marlon Honeywell, PharmD
Associate Professor of Pharmacy Practice,
Florida A&M University College of Pharmacy, Tallahassee

1/23/2007

US Pharm. 2007;1:82-87.

In 2005, an estimated 20.8 million people in the United States had diabetes mellitus.1 Diabetes comprises a group of metabolic disorders resulting from a defect in insulin production, action, or both. It is characterized by chronic hyperglycemia and disturbances of carbohydrate, protein, and fat metabolism that can result in microvascular, macrovascular, and neuropathic complications. 2 Type 1 diabetes results from an autoimmune destruction of the pancreatic beta cells. This type usually is found in children and adolescents, although the disease onset can occur at any age. Patients with type 1 diabetes have little or no pancreatic function, a tendency to develop ketoacidosis, and a dependency on exogenous insulin to sustain life. Type 2 diabetes is characterized by variable degrees of insulin resistance, impaired insulin secretion, and increased glucose production. This type is typically recognized in adulthood but is becoming more prevalent among obese children. Furthermore, the prevalence of type 2 diabetes increases with age. In the U.S., type 2 diabetes is more common in women than in men. The incidence also varies among different racial and ethnic populations, with the highest incidence observed in Native Americans, Hispanic-Americans, Asian-Americans, African-Americans, and Pacific Islanders.3 Ninety percent of the total diagnosed cases of diabetes are type 2, while 10% are type 1.

Monitoring
Monitoring is a critical part of diabetes management. Patients must be well educated about the importance of monitoring and appropriate techniques. There is an established relationship between monitoring, therapy compliance, and risk of complications. 4 Laboratory values that are commonly monitored include glucose and glycosylated hemoglobin (GHb) measurements.

Though generally inexpensive and mildly invasive, glucose monitoring may be performed many times per day by the patient in the comfort of his or her own home. Generally, patients are instructed to monitor before and after meals. Blood samples as small as 1 mcL may be taken from a number of sites including the finger, forearm, arm, abdomen, thigh, and calf.5 Glucose levels can be altered by diet, exercise, and medications.6

Evaluated every two to three months, GHb values are directly proportional to glucose concentration and duration of exposure.7 Although there are several species of glycohemoglobin, HbA1c is the most prevalent and is traditionally monitored in clinical practice.7 Usually performed in the doctor's office, this method also requires only a small amount of blood. Achieving the optimal goal for HbA1c (? 7%) is associated with a reduced risk of secondary complications. Several studies have illustrated that improved glycemic control reduces the risk of secondary complications by 35%.7 Every percentage point decrease in HbA1c results in a significant reduction in the risk of microvascular complications and diabetes-related deaths.4 The American Diabetes Association recommends twice-yearly monitoring in patients with controlled glycemic levels, with more frequent evaluations in those who have not met their glycemic goals. African-American patients tend to have higher HbA1c values.

Monitoring Devices
With the availability of more than 20 brands, glucose monitoring is easily achieved with a glucose meter (usually handheld) that requires a single drop of blood. More than 20 brands of glucose meters are available. Most differ only by the amount of time or blood necessary to achieve a reading and memory or by the number of test strips the machines are able to hold. Newer glucose monitors go beyond conventional handheld devices and take samples throughout the day without the patient's assistance. Some examples include glucose meter watches and implanted transmitters.

Glycohemoglobin monitoring is challenging because of the varying combinations of hemoglobins. Some laboratories choose to report total glycosylated hemoglobin, while others report HbA1c. Several efforts have been taken by the National Glycohemoglobin Standardization Program (NGSP) to standardize the measurement. 

The A1CNow+
With an increase in the prevalence of diabetes and the potential serious complications of the disease, home testing of HbA1c should be an integral part of diabetes management. Metrika's A1CNow+ (see Figure 1) is the first nonprescription device that patients with diabetes can use at home to obtain immediate HbA1c results between office visits. The A1CNow+ is a portable, easy-to-use device that provides rapid HbA1c results with precision and accuracy.8 A1CNow+ requires approximately 10 mcL of blood. The blood is diluted with 0.69 mL of the buffered detergent solution ferricyanide and is directly applied to the sample port. Results are displayed in numeric form on the monitor's liquid crystal display after five minutes. The device self-activates upon insertion of the test cartridge, and no fasting is required before obtaining the blood sample. Test results are expressed as %A1c, representing glucose control over the last three months. 9 Patient instructions are located in Figure 2.






Efficacy
Metrika's A1cNow + has undergone various studies to determine its efficacy and accuracy. When compared to a variety of laboratory tests certified by the College of American Pathologists, %A1c results were similar. The A1CNow+'s results have been shown to be within 0.9% of the A1c value allowed by the NGSP. 10 In 2005, a study comparing BioRad Variant II, A1CNow+, and a NGSP Certified laboratory test revealed that A1CNow+ was within 1% of the A1c value allowed by NGSP.11 

Conclusion
Metrika's A1CNow + is an excellent addition to at-home testing for patients with diabetes. Since it measures HbA1c, it allows both the patient and the clinician to monitor overall patient progress. This device is patient-friendly and does not require a prescription. It should supplement patient self-care between physician visits and is not intended to replace daily monitoring.

References

1. Centers for Disease Control and Prevention Web site. Available at: www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. Accessed October 31, 2006.

2. DiPiro J, Talbert R, et al. Pharmacotherapy: A Pathophysiologic Approach. 5th ed. New York: McGraw Hill; 2002:1335-1358.

3. Fauci A, Braunwald E, et al. Harrison's Principles of Internal Medicine. 16th ed. New York: McGraw-Hill; 2005:2152-2180.

4. Krapek K, King K, et al. Medication adherence and associated hemoglobin A1c in type 2 diabetes. Ann Pharmacother. 2004;38:1357-1362.

5. Dufaitre-Patouraux L, Djemli K, Vague P. How and when to use an alternative site in self-monitoring of blood glucose. Diabetes Metab. 2004;30:471-477.

6. Chin M, Cook S, et al. Barriers to providing diabetes care in community health centers. Diabetes Care. 2001;24(2):268-274.

7. Krishnamurti U, Steffes M. Glycohemoglobin: a primary predictor of the development or reversal of complications of diabetes mellitus. Clin Chem.2001;47(7):1157-1165.

8. Metrika Web site. Available at: www.metrika.com. Accessed November 2, 2006.

9. Metrika's A1CNow+ Professional-Use Product Insert. Available at: www.metrika.com. Accessed November 2, 2006.

10. Metrika comparative A1C results across laboratories. Metrika, Inc. December 2002.

11. Field study using A1cNow InView. Metrika, Inc. December 2005.

To comment on this article, contact editor@uspharmacist.com.

 

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U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia. The publication is also useful to pharmacy technicians, students, other health professionals and individuals interested in health management. Pharmacists licensed in the U.S. can earn Continuing Education credits through Postgraduate Healthcare Education, LLC, accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

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