This is a companion article to “The Need for Point-of-Care HbA1c Testing for Diabetes.”

Researchers continue to study the clinical utility of point-of-care (POC) HbA1c testing for diabetes applications. Two areas in particular have shown promise that may signal forthcoming changes in clinical practice guidelines on HbA1c testing. 33,34

HbA1c Testing for Diabetes Diagnosis

HbA1c testing is essential for assessing glycemic control in diabetic patients. Now, it can also play an earlier role, as a rapid and cost-effective diagnostic tool for diabetes.5 The diabetes care guidelines issued by the American Diabetes Association (ADA) in 2018 include HbA1c testing as an option for diagnosing diabetes, using a standardized central laboratory method certified by the National Glycohemoglobin Standardization Program, but not a POC method.9 However, one POC method was recently cleared by FDA for use as an aid in the diagnosis of diabetes at testing sites that maintain a CLIA license for performing moderately complex tests.

In a 255-patient study, the results from POC testing for HbA1c aligned almost fully with the results from standard laboratory testing, with five new diabetes cases diagnosed by the central laboratory and six by POC testing.35 Diagnosis using POC HbA1c tests is not currently recommended by ADA. Nevertheless, according to ADA, such POC testing for HbA1c “may be considered in the future, if proficiency testing is performed and documented.”9

This is an area where further investigation may help to determine whether decentralized testing can provide the necessary accuracy, and be implemented in such a way that it becomes helpful for identifying people who have undiagnosed diabetes.

HbA1c Testing to Identify Prediabetes

Targeted testing to identify patients with prediabetes could have long-term health and economic benefits by allowing providers to intervene earlier to help prevent diabetes and its associated complications. HbA1c test results have been shown capable of predicting the development of type 2 diabetes in the short- and long-term.36

One POC HbA1c test was recently cleared by FDA for identifying patients at risk for developing diabetes. A recent study found that POC testing for HbA1c in the physician’s office was 22% more effective at revealing chronic hyperglycemia and prediabetes than standard laboratory glucose testing.37 Similar to POC HbA1c testing to diagnose diabetes, there is need of further evidence and the appropriate FDA clearances before any point-of-care method can be implemented to identify prediabetes.