Lab Innovations Improve Lives for Diabetes Patients
Wednesday, November 20, 2013
At age 17, Ryan Reed was already on his way to a promising career as a race car driver when he was diagnosed in early 2010 with Type 1 diabetes. For the Bakersfield, Calif., teenager, it appeared that his future as a NASCAR racer was in jeopardy.
“There is a seven to 10-year gap between the time that type 2 diabetes develops and when it is diagnosed, by which time the complications have manifested themselves and are irreversible.”
—David Sacks, MD, FASCP
Since then, Ryan worked relentlessly to learn as much as he could about diabetes and got his illness under control. His racing career is back on track, thanks to advances in clinical research to improve the diagnosis and treatment of the disease.
Ryan lent his name to the American Diabetes Association’s (ADA) Stop Diabetes campaign during November, which is designated as American Diabetes Month. He is among nearly 26 million adults and children in the United States living with the disease, according to the ADA.
David Sacks, MD, FASCP, Chief of Clinical Chemistry Service in the National Institutes of Health, has worked closely with the ADA to study diabetes, with a particular emphasis on the interface between the medical laboratory and patient care.
“There is a seven to 10-year gap between the time that type 2 diabetes develops and when it is diagnosed, by which time the complications have manifested themselves and are irreversible,” he says.
An aging baby boomer population and a rise in obesity and sedentary lifestyles are contributing to this epidemic, which could lead to as many as one in three American adults will have diabetes in 2050, according to recent projections. Currently, there are approximately 79 million people diagnosed with pre-diabetes—which can lead to Type 2 diabetes.
One test that has resulted in a huge improvement of medical laboratories in the diagnosis and management of diabetes is the hemoglobin A1C test, which the ADA adopted for diagnosis of diabetes in 2010. Whereas the fasting glucose test only provides a snapshot of an individual’s blood sugar level for a brief period in a day, the A1C test measures an individual’s average level of glucose in the blood over a period of two to three months.
“In healthy people, five percent of their total hemoglobin is hemoglobin A1C, whereas a person with diabetes could have 10 to 15 percent of hemoglobin A1C in their blood,” Dr. Sacks says. “Clinical studies showed a change of one percent has an enormously positive impact. The challenge in the past was that if you sent a sample to one lab, their instruments could give a 9 percent reading and you could get a 21 percent reading for the same sample from another lab.”
Dr. Sacks chairs the National Glycohemoglobin Standardization Program (NGSP) steering committee which has established standards that require manufacturers of the hemoglobin A1C test to calibrate their diagnostic instruments and apply for certification to demonstrate that they meet the criteria for accuracy.
“The standardization is huge,” he says. “The one advantage of A1C for diagnosis is that you can draw the blood any time of the day so that whenever the patient has any interaction with a healthcare provider, they can draw the blood and use it to diagnose for diabetes.”