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Portable Diabetes Test Device (A1cNOW) Doesn't Provide Consistent, Standard Readings to Monitor Blood Sugar

Suppose you want to know how you've done overall. There's a test that can help. An A1C (also known as glycated hemoglobin or HbA1c) test gives you a picture of your average blood glucose control for the past 2 to 3 months. The results give you a good idea of how well your diabetes treatment plan is working.One way to keep track of your blood sugar changes is by checking your blood sugar at home.HbA1c is normal if it is 5% or less. Normal ranges may vary slightly depending on the laboratory used.

These tests tell you what your blood sugar level is at any one time. This blood test can tell someone with diabetes if his or her diabetes is under control or out of control.This test measures blood sugar control over an extended period in people with diabetes. In general, the higher your HbA1c value, the higher the risk that you will develop problems such as eye disease, kidney disease, nerve damage, heart disease, and stroke. This is especially true if your HbA1c remains elevated on more than one occasion.The closer your HbA1c value is to normal, the less risk you have for these complications.

This blood test measures the amount of glycosylated hemoglobin in the blood. You may wonder what it has to do with your blood sugar control. Hemoglobin is found inside red blood cells. Its job is to carry oxygen from the lungs to all the cells of the body. Hemoglobin, like all proteins, links up with sugars such as glucose.

You know that when you have uncontrolled diabetes you have too much sugar in your bloodstream. This extra glucose enters your red blood cells and links up (or glycates) with molecules of hemoglobin. The more excess glucose in your blood, the more hemoglobin gets glycated. It is possible to measure the percentage of A1C in the blood. The result is an overview of your average blood glucose control for the past few months.

A1C tests can help:

Confirm self-testing results or blood test results by the doctor
Judge whether a treatment plan is working
Show you how healthy choices can make a difference in diabetes control.

A portable device called A1cNow, which is designed to provide a long-term picture of blood sugar control, does not provide accurate or consistent results in children with type 1 diabetes, researchers report in the journal Diabetes Care.

The A1cNow monitor is the first of its kind, single use, disposal test for hemoglobin A1c. This valuable diabetes management device is easy to use and requires a single drop of blood for accurate results in only minutes.A1cNow is available without a prescription for home use by your patient or in your office.

"At present, the routine use of the A1cNow in children with type 1 diabetes cannot be recommended," lead investigator Dr. Larry Fox told Reuters Health.

The monitor measures a component of blood called hemoglobin A1c, which indicates how well blood sugar levels have been controlled over several months. Standard blood sugar monitors only indicate diabetes control over the last few hours.

In the current study, Dr. Fox of Nemours Children's Clinic, Jacksonville, Florida and colleagues compared the results obtained with A1cNow with those of obtained using a clinic-based hemoglobin A1c tester, the DCA2000.

The researchers found that the DCA2000 was consistently more accurate than the A1cNow. In all, 32 percent of A1cNow values differed from a reference standard by more than 0.5 percent, while only 3 percent of DCA2000 readings were off to that degree.

There were no clinically significant differences in accuracy regardless of whether readings were taken by patients, parents or staff.

However, the team notes that when simultaneous measurements were made using the A1cNow, either in the clinic or at home, there were marked differences in values. This, they conclude, indicates problems inherent in the device.

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Comments

Further research urgently

by David Spector - 2010-02-19 13:11

Further research urgently needed

It would be better to have more in-depth information and research on this device. If (as I've seen reported as anecdote) the device can be in error by as much as 10% relative to a known accurate value, this would not be acceptable for diagnostic or therapeutic guidance and the device should be removed from the market. It would not be difficult for any clinic to perform a statistically significant study and resolve this issue. This should be done quickly, considering the potentially destructive effect of incorrect A1c readings for our patients.

David Spector
Waltham, Massachusetts