New York University's Clinical and Translational Science Institute (CTSI) has awarded an NYU nursing-dental research team a one-year pilot grant to assess the feasibility of using gingival crevicular blood from periodontal patients to gauge hemoglobin A1C -- a blood glucose measurement -- as a means of diagnosing diabetes and identifying pre-diabetes. CTSI is a partnership between New York University's Langone Medical Center and the New York City Health and Hospitals Corporation funded by a grant from the National Center for Research Resources of the NIH.
The hemoglobin A1C test has long been used to measure how well people already diagnosed with diabetes have their blood glucose levels under control. In January 2010, the American Diabetes Association issued new clinical practice recommendations calling for the addition of the hemoglobin A1C test as a means also of diagnosing diabetes and diabetic risk.
Led by Dr. Shiela Strauss, associate professor of nursing and Co-Director of the Statistics and Data Management Core for NYU's Colleges of Nursing and Dentistry, the study will gauge levels of hemoglobin A1C utilizing a version of an A1C testing kit that was initially developed specifically to enable dentists and dental hygienists to collect finger-stick blood samples and send them to a laboratory for analysis.
Dr. Strauss has adapted the testing kit to include oral blood as well as finger-stick samples. Using Dr. Strauss's adapted version of the test, oral healthcare providers can play a role in screening patients for diabetes without having to draw and analyze venous blood samples, a process requiring certification by the Centers for Medicare & Medicaid Services, a division of the US Department of Health and Human Services.
Dr. Strauss will recruit periodontal patients for the research because an earlier study that she led found that over 90 percent of people with periodontal disease but with undiagnosed diabetes are at risk for diabetes and should be screened for diabetes, based on the American Diabetes Association's guidelines. Dr. Strauss's research team will recruit 120 subjects from the NYU College of Dentistry's periodontal treatment program for the new study. Each subject will provide one finger-stick blood sample and, if there is oral bleeding, one blood sample drawn from a deep pocket of gum inflammation.
Dental and dental hygiene students and faculty will collect the oral blood samples, while the subjects will either draw their own finger-stick blood or do so with help from the students and faculty. Both samples will be sent to the same laboratory, which will determine whether subjects' hemoglobin A1C levels are in the normal, pre-diabetic, or diabetic range. The research team will compare the laboratory results to see if there is a correlation between A1C levels in the finger and oral blood samples.
Dr. Mary Rosedale, an assistant professor of nursing, will counsel those subjects whose finger- stick hemoglobin A1C levels are determined to be in the diabetic range regarding the importance of follow-up. Dr. Rosedale will also interview subjects to assess their reactions to diabetes screening in a dental setting.
Dr. Strauss indicates that A1C testing may be more easily-incorporated into a dental visit than a fasting blood glucose screening -- often the first test for diagnosing diabetes -- since most people don't fast before seeing a dentist.
"If we find a high correlation between the A1C finger-stick and oral blood samples in our new study, we plan to conduct additional research on oral blood A1C testing involving a broader pool of subjects and dental practice sites," said Dr. Strauss.
An earlier NYU nursing-dental study led by Dr. Strauss suggested that the dental visit could be a useful opportunity to conduct an initial diabetes screening. In that study, researchers used a testing device known as a glucometer to screen 46 subjects with periodontal disease for casual blood glucose levels, measuring blood glucose without regard to when a person last ate. The study determined that the glucometer can provide glucose-level readings that are highly correlated with glucometer readings for finger-stick blood samples when oral blood samples are drawn from deep pockets of gum inflammation.
"There is a critical need to increase opportunities for diabetes screening and early diabetes detection," Dr. Strauss noted. "The issue of undiagnosed diabetes is especially critical because early treatment and secondary prevention efforts may help to prevent or delay the long-term complications of diabetes that are responsible for reduced quality of life and increased levels of mortality risk."
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