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Study: Traditional Testing Misses More Than 80% of Patients With Diabetes Risk Factors

Authors champion multimarker approach

Comprehensive biomarker testing of insulin resistance and pancreatic beta-cell dysfunction identifies diabetes risk earlier than current glycemia-based approaches, according to a new study published online in the Journal of Cardiovascular Translational Research.

The study assessed 1,687 patients at risk of cardiovascular disease receiving routine clinical care with a comprehensive panel of biomarkers related to insulin resistance (IR), beta-cell function, and glycemic control. On the basis of traditional fasting glucose and hemoglobin A1c (HbA1c) levels, 415 patients (25%) had glycemic indicators consistent with prediabetes and 343 (20%) had indicators consistent with diabetes, reflecting a high-risk cohort. However, 766 patients that were not classified as “at risk” of developing diabetes by traditional measures were identified with one or more biomarkers of IR or beta-cell dysfunction.

After 5 months of treatment and lifestyle intervention, the proportion of patients who improved their glycemic status was significantly greater than those with worsened status (35% vs. 9%, respectively; P < 0.0001). Among those in the “high normal” category of HbA1c values (5.5 to 5.6), glycenic status improved in 56% of patients and worsened in 18% (P < 0.0001).

The study’s key findings also included the following:

  • Physiologic signs of IR and beta-cell dysfunction were identified in 80% of at-risk individuals who would have been classified as “normoglycemic” by conventional glycemic criteria.
  • No single biomarker was responsible for the increased sensitivity; diverse patterns of biomarker abnormalities were observed, particularly in patients with normal glycemic markers.
  • Improvements in the glycemic category observed in the subset of patients for which follow-up data were available suggest that the multimarker approach may be successfully implemented in routine clinical practice.

Diabetes affects more than 25 million people in the U.S. and more than 366 million people worldwide. According to the authors, if trends continue, one in three Americans will meet the criteria for diabetes by 2030. Prediabetes affects more than 87 million U.S. adults and confers a 30% to 50% lifetime risk of conversion to diabetes. Insulin-resistance syndromes (i.e., diabetes, prediabetes, and metabolic syndrome) are associated with up to 70% of cases of cardiovascular disease, and adults with diabetes are twice as likely to die from heart disease and stroke than are those without diabetes.

The American Diabetes Association estimates that the average cost of managing diabetes for 1 year is $7,900 per patient, and the treatment of type-2 diabetes is projected to cost the U.S. $500 billion per year by 2020.

Sources: Health Diagnostic Laboratory, Inc.; August 6, 2014; and JCTR; July 29, 2014.

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