FAQ About the DRA:

What is the Diabetes Risk Kit 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 Diabetes Risk Kit is a combination of the HbA1c test and the fasting glucose test – which measures current blood glucose levels. Together, they provide an assessment of the likelihood of developing diabetes. As a result, the Diabetes Risk Kit is considered a screening test for diabetes and the first and only such combination test on the market.

What advantages does the Diabetes Risk Kit have versus going to my doctor’s office for the same tests?

The diagnostic components of Diabetes Risk Kit are cleared by the FDA as being “substantially equivalent” to tests performed in physician’s offices and clinical reference laboratories. Also, the Diabetes Risk Kit combines two tests in one package.  These same two tests would be conducted separately in a doctor’s office. Lastly, the cost of the Diabetes Risk Kit 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 Diabetes Risk Kit?

Only an eight hour fast is required and one drop of blood. Everything needed to conduct the Diabetes Risk Kit 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 generated within 72 hours and sent to the participant.

Since the Diabetes Risk Kit 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 Diabetes Risk Kit 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 57 million people in the United States who have pre-diabetes and don’t even know it.

How accurate is the Diabetes Risk Kit?

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 an accuracy of over 95% in classifying diabetes risk.