Blood Test Identifies Prediabetics with Highest Risk of Developing Diabetes Before Symptoms Develop

Type 2 diabetes takes years to develop but is preventable if caught early. However, just 50% of people with prediabetes go on to develop full-blown diabetes over a period of 10 years. Unfortunately, current diabetes tests such as hemoglobin A1C and fasting glucose are incapable of accurately identifying prediabetic individuals who are at the highest risk of progression. Now, a blood test can identify high-risk, asymptomatic patients with prediabetes who cannot be detected by standard diabetes tests, hemoglobin A1C and glucose. The blood test meets a critical clinical need as it can be used by physicians to identify patients closest to developing type 2 diabetes and provide treatment to prevent the onset of the disease.

GlycoMark from Precision Diabetes, Inc. (Raleigh, NC, USA) is an FDA-cleared, non-fasting serum or plasma test for monitoring blood glucose variability in people with diabetes. The GlycoMark test provides quantitative measurement of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. As the GlycoMark test reflects a progressive decline of functional beta-cell mass, it can identify prediabetic patients with the highest risk of developing diabetes before the first symptoms develop. Most high-risk patients can prevent the development of type 2 diabetes by making lifestyle changes such as eating a well-balanced diet, exercising and maintaining a healthy body weight.

Image: The GlycoMark test is a 10 minute, two-step enzymatic kinetic assay (Photo courtesy of Precision Diabetes)

In a new study, the GlycoMark blood test has shown that it can identify high-risk, asymptomatic patients with prediabetes, not detected by standard diabetes tests, hemoglobin A1C and glucose. The finding is extremely important as there is a significant clinical need for a sensitive and robust biomarker of functional beta-cell mass (beta cells are cells in the pancreas that produce insulin). A functional beta-cell mass biomarker is essential to identify which prediabetic individuals have the highest risk of progression to diabetes.

"This study not only has significant clinical implications as there has been a long search for an accurate biomarker of beta-cell function, but given the sheer numbers of people with prediabetes, it is important to target the highest-risk patients from a public health and economic standpoint," said Eric Button, CEO of Precision Diabetes, Inc. "GlycoMark will be an important tool in stratifying these patients for follow-up treatment."

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Precision Diabetes, Inc.