New home test for diabetics

Many diabetics check their blood glucose levels several times a day, but they’ve had to visit a doctor for a test to determine whether the disease is under control. Now, they’ll be able to buy that test without a prescription for use at home.

The test, approved for over-the-counter sale earlier this month, measures glycated hemoglobin. The substance is produced when sugar levels rise and interact with the hemoglobin in red blood cells. Because red cells live 90 to 120 days, the so-called A1c test result shows how well a patient has kept his or her blood sugar within the target range over a few months.

“The A1c is a very, very important measure of the control of the blood glucose level,” said Dr. Francine R. Kaufman, president of the American Diabetes Assn. “For the most part, [the test] should be done quarterly and linked to a health care visit.”

The FDA decision should benefit those among the nation’s 17 million diabetics who aren’t routinely being tested at a doctor’s office.

People with Type 1 diabetes, especially children, tend to see specialists who test them regularly, but those with Type 2 diabetes often are treated by primary-care doctors who may be less likely to order A1c tests, said Kaufman, head of pediatric endocrinology at Childrens Hospital Los Angeles. In Type 1 diabetes, the pancreas stops making the insulin necessary to metabolize sugar. In the more common Type 2 diabetes, the body makes too little insulin and responds poorly to the little it does make.

Dr. Anne Harmel, director of clinical diabetes programs at USC, said a home test could help patients better monitor their disease and push for better care. It also could benefit patients who have trouble getting to the doctor, she said.

Diabetics already do finger-stick blood tests using a small glucose meter to measure their blood at that moment. The reading helps them calculate how much insulin to use.

Kaufman and Harmel warned that the home A1c test is no substitute for a comprehensive medical visit. Besides checking blood sugar levels, doctors use visits to check for such diabetic complications as high blood pressure, high cholesterol, kidney problems, blindness and slow-healing sores that sometimes lead to amputation.

Kaufman said she feared that self-testing could deter patients from seeing doctors, while encouraging health plans to shift more responsibility onto patients.

The A1c test, manufactured by Metrika Inc. of Sunnyvale, Calif., has a suggested retail price of $24.95.