New Study Shows GlycoMark® Test Identifies Prediabetic Individuals with the Highest Risk of Developing Diabetes Before Symptoms Develop

RALEIGH,N.C.,Feb. 21,2023 -- A new study indicates that the GlycoMark blood test identifies high-risk,asymptomatic patients with prediabetes,not detected by standard diabetes tests,hemoglobin A1C and glucose – a critical clinical need,as physicians can identify those patients closest to developing type 2 diabetes and administer treatment to prevent the onset of diabetes.

The study,"Circulating 1,5-Anhydroglucitol as a Biomarker of Beta-Cell Mass Independent of a Diabetes Phenotype in Human Subjects," was recently published in the Journal of Clinical Endocrinology and Metabolism by Pierre Maechler et al.,from the University of Geneva (Geneva,Switzerland). The authors of the study conclude,"In this study we show that 1,5-anhydroglucitol (GlycoMark measures 1,5-anhydroglucitol) is a circulating biomarker of the in vivo loss of functional beta-cell mass,independently of altered glycemic control,even ahead of diabetes onset." This 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.

Type 2 diabetes can take years to develop,and if caught early,it is an entirely preventable disease. However,not everyone with prediabetes will develop type 2 diabetes. Only 50 percent of people with prediabetes develop full-blown diabetes over 10 years. Unfortunately,it is not possible with current diabetes tests such as hemoglobin A1C and fasting glucose to identify with an acceptable degree of certainty which prediabetic individuals have the highest risk of progression.

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. By making positive lifestyle changes such as eating a well-balanced diet,exercising regularly,and maintaining a healthy weight,many of these high-risk patients can prevent the development of type 2 diabetes entirely.

"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."

Recently published studies also validate the association of 1,5-anhydroglucitol (GlycoMark) with beta-cell function and mass:

1) Association between 1,5-Anhydroglucitol and Acute C Peptide Response to Arginine among Patients with Type 2 Diabetes (Shen et al.,Journal of Diabetes Research,2020)

2) 1,5-Anhydroglucitol x glycated hemoglobin A1C/100 as a potential biomarker for islet cell beta-cell function among patients with type 2 diabetes (Su et al.,Acta Diabetologica,2020)

3) Metabolomics Identifies a Biomarker Revealing In Vivo Loss of Functional Beta-Cell Mass Before Diabetes Onset (Li et al.,Diabetes,2019)

About GlycoMark® Test

GlycoMark is an FDA-cleared and CE-marked non-fasting blood test. Since its discovery,the GlycoMark test,a quantitative test for 1,5-Anhydroglucitol (1,5-AG),has been described in more than 1,300 scientific and medical publications. GlycoMark is available at major reference laboratories in the United States and worldwide. More information is available at www.glycomark.com.

About Precision Diabetes,Inc. (PDI)

Precision Diabetes,Inc. (Raleigh,North Carolina) is the exclusive supplier of the GlycoMark test in the U.S.,Europe,Australia,the Asia-Pacific Region,the Middle East,and Mexico. Precision Diabetes is an emerging leader in enabling precision medicine for diabetes using novel diabetes biomarkers and algorithms. The company's mission is to revolutionize the diagnostic assessment of diabetes by providing a spectrum of unique diabetes tests,spanning the risk of developing diabetes to developing diabetes complications. More information is available at www.precisiondiabetesinc.com.

MEDIA CONTACT

Juliana Button

919-903-1391

jbutton@precisiondiabetesinc.com