FREQUENTLY ASKED QUESTIONS

What is the Diabetes Risk Assessment (DRA) and how does this differ from the HbA1c test?

The HbA1c test measures the average blood sugar level over a 90-day period and is the standard self-monitoring test for people with diabetes.  The DRA is a combination of the HbA1c test and the fasting blood glucose test – which measures current blood sugar levels.  Together, they provide an assessment of the likelihood of developing diabetes.  As a result, the DRA is considered a screening test for diabetes and the first and only FDA approved such test.

What advantages does the DRA have versus going to my doctor’s office for the same screening tests?

The DRA is cleared by the FDA as being “substantially equivalent” to tests performed in physician’s offices and clinical reference laboratories.  Also, the DRA combines two tests in one package.  These same two tests would be conducted separately in a doctor’s office and billed accordingly.  Lastly, the cost of the dental office screening DRA is significantly lower than that of the corresponding office visit to the doctor and associated lab charges.

Do I need to undertake any kind of preparation for the DRA?

Only an eight hour fast is required and one drop of blood.  Everything needed to conduct the DRA is contained within the packaging.  In a recent questionnaire, 99% of respondents said that the instructions were easy to follow and understand.

How soon can I get the lab results back?

The fasting glucose portion of the test only takes 3 minutes in order to get a result.  Should the fasting glucose value be 75 mg/dL or higher, the top tab of the test card needs to be sent in for confirmatory HbA1c testing.  Upon receipt, a lab report is typically generated within 5 business days and sent to the participant.

Since the DRA is a screening test for diabetes, what information can I expect from the lab report?

The HbA1c and fasting glucose data are plotted on a graph with the corresponding point being the result.  Contingent on where that point lies on the colored graph, the participant will either be within normal range (green area), pre-diabetic (yellow area) or diabetic (red area).  The value of the DRA is the ability to accurately identify people with pre-diabetes so that they can make lifestyle changes in order to decrease the likelihood of developing diabetes.  Pre-diabetes is when the blood glucose levels are higher than normal yet not high enough to be diagnosed as diabetes.  There are more than 60 million people in the United States who have pre-diabetes and are unaware of their risk. 

 How accurate is the DRA?

Individually, for analytical accuracy, the HbA1c test is 98% accurate and the fasting glucose is reported to be 94% accurate.  When combined, the two tests provide a statistically more powerful likelihood of identifying diabetes than if either test was offered by itself. 

For patients who come to my office in a non-fasting state, could I still administer the Diabetes Risk Assessment (DRA) Test?

The diabetes risk assessment combines an immediate glucose as a measure of blood sugar at the time of collection, and a hemoglobin A1c (HbA1c) as a measure of average daily glucose over the previous 3 months.  For the most accurate diabetes risk assessment, a fasting glucose is the best indicator since the American Diabetes Association has established its diagnostic criteria on fasting blood glucose.  However, when a fasting level is not practical, a random glucose still provides some value.  Should the non-fasting glucose result be normal (under 100 mg/dL), in most cases the fasting glucose will also be less than 100 mg/dL.   If the non-fasting result is elevated, the advantage of the DRA is that it includes an HbA1c as a valuable second level test that does not require fasting.   If the HbA1c is elevated, the patient should be referred to a physician for additional testing.  If the HbA1c is normal (less than 6.0%), repeating the glucose in a fasting state is not necessary.

 Why is it necessary to do 2 tests for diabetes detection?

Only the Healthy Heart Dentistry DRA combines rapid glucose WITH an HbA1c.  Without the glucose, the screening guidelines of the American Diabetes Association are not being followed.  And without the HbA1c, there is no assurance that periods of elevated blood sugar are not being missed with a fasting glucose alone.  Remember that getting people screened is only half the battle.  Screening with the right test (or combination as in our case) is paramount to identifying those at risk for diabetes. 

 
If I can visibly see evidence of inflammation like redness and swelling, why it is necessary to do a blood test for CRP, when all it does is serve as a non-specific indicator of inflammation?

Your eyes are your best weapon at detecting the visible signs of oral inflammation.  However, the occult or hidden inflammation throughout the body’s circulatory system remains the silent stalker.  The recent Jupiter™ study which looked at heart disease risk and the most effective treatments proved convincingly that even in cases of normal cholesterol, CRP is an independent risk factor for cardiovascular disease.  The inflammatory process is best detected and monitored with a high-sensitivity C-Reactive Protein (hsCRP), as CRP is elevated in conditions of infection, injury and inflammation.  The Healthy  Heart Dentistry hsCRP blood test is ideal to establish a baseline level, even if visible inflammation is apparent.  Then following a course of treatment to reduce inflammation, the hsCRP test should be re-administered.  In cases where the CRP levels remain elevated (over 3.0 mg/L), there is an underlying medical condition, and referral to a primary care physician in necessary.  Case studies reported by users of the Healthy Heart Dentistry hsCRP kit include secondary detection of cancers (prostate, colon, lymphoma), gall bladder inflammation, and coronary heart disease.      

What health improvements have Dentists seen since doing screening?

Below is a summary of the 2008 pilot study:

-Six-month pilot of 100 dentists in 30 states in 2008
-95% practices submitted specimen(s)
-5,230 specimens submitted on dental patients
-63% at increased risk for diabetes
-54% with elevated cholesterol
-70% with active inflammation (elevated CRP)
-60% of participating offices reordered kits

Can these tests be used on children?

Yes, all of the Healthy Heart Dentistry Tests are suitable for pediatric patients, as only 1 drop of fingernick blood is required for the DRA, and 3 drops for the hsCRP.  The safety lancets enclosed within the test kits are designed for blood collection in those over the age of 2.  The reference and risk ranges for these tests are the same regardless of age or gender.

Could you share some of your results of using these tests on children?

In July of 2008, the DRA was made available to RediClinics in Wal-Mart stores in the Richmond, VA area.  Below is a summary of our findings:

  27% of children screened were found to be at increased pre-diabetic risk

  80% of children who tested at higher risk were obese based on BMI calculation

  Two children screened were subsequently diagnosed with type 2 diabetes

Ø  Pilot data supports hypothesis that there are significant numbers of children at risk for diabetes whose families are unaware of the disease etiology and would benefit from an awareness, education, assessment and call-to-action campaign

How do these tests help with physician and area healthcare professionals refer quality patients to the dental office?

Successful dental offices have established a bi-directional referral arrangement with primary care physicians.  Since more people see their dentist than their primary care doctor, the dentist is in an ideal role to provide education and screening for diabetes and inflammatory diseases.  Referring patients to primary care physicians who are at risk for diabetes (by test outcome and/or symptomatically) or who have sustained elevations of CRP, is providing a valuable service to the patient.  Referred physicians have similarly begun referring patients with migraine headaches and sleep apnea to their new dental partners to investigate the oral causes of migraine.  The American Medical Association has embraced the oral-systemic connection, as evidenced by the December 2008 article in JAMA.   [JAMA. 300(21):2471-3.]  It is up to the dental professionals to embrace this opportunity and emerge as the champions in this arena. 
 

Clinically, how has using hsCRP impacted results in achieving stability of an active disease process?

Monitoring hsCRP as part of treatment and ongoing maintenance of periodontal inflammation is key to ensuring that underlying bacterial pathogens are not re-emerging to compound the gingival or periodontal inflammation, as CRP will often be elevated even in the absence of inflammatory symptoms.  Continuous use of an oral health system (i.e. Closys) and implementation of nutritional oral supplements in the form of Pharmaden’s PerioTherapy and PerioCare further serve to ensure that the oral inflammation remains in check between visits.

  
What is the false reading % on each test in the Diabetes Risk Assessment?

The finger nick tests in the DRA have been determined to have the same clinical accuracy as blood tests drawn from the vein.  Glucose and HbA1c when combined provide a greater likelihood of detecting diabetes than using either test as a standalone.  When either test provides an elevated result, the patient’s blood glucose levels is not being well maintained, and further investigation is required by a primary care physician.  Conditions other than diabetes could elevate blood glucose, but the state of glucose intolerance detected by the testing exceeds 98% accuracy.

  
If all tests come back negative, what are your recommendations to that patient?

Our best advice is always to discuss the results with your primary care doctor.  If a person is at risk for diabetes and their screen is negative, that’s good news, but only part of the overall picture.  If there are other symptoms associated with diabetes (thirst, frequent urination, dizziness, weight loss, bleeding gums), these symptoms may be associated with other underlying conditions other than diabetes.  Not all diseases are diagnosed with blood tests.  Be assured that you have provided a valuable piece of diagnostic information to your patient, who is now more educated about diabetes, and is more likely to feel at ease talking about his/her symptoms when seeing their doctor.