Diabetes testing guidelines deserve support from the lab community

Nov. 23, 2021

Diabetes is one of the most common chronic diseases in the United States.

In 2018, 34.2 million Americans, or 1 in 10, had diabetes and 88 million American adults, or 1 in 3, had prediabetes, according to the Centers for Disease Control and Prevention (CDC). In addition, 7.3 million adults aged 18 years or older who met laboratory criteria for diabetes were not even aware that they had the disease.

Diabetes also is a major contributor to the nation’s annual healthcare tab. In a 2018 report, the American Diabetes Association (ADA) said the total estimated 2017 direct medical costs from diagnosed cases of diabetes was $237 billion.

On an individual level, each person diagnosed with diabetes incurs average medical expenditures of $16,752 per year, of which about $9,601 is directly attributable to diabetes, the ADA said, adding that this per-person cost is about 2.3 times higher than it is for people without a diabetes diagnosis.

None of this is news to clinical laboratorians. Testing to diagnose new cases of diabetes and prediabetes or to monitor blood sugar control in existing cases of diabetes is an important part of the daily workflow at many clinical labs.

What may be news to laboratorians, however, is an ongoing effort on the part of the ADA and the American Association for Clinical Chemistry (AACC) to update diabetes testing guidelines. The guidelines were first crafted in 2002 and revised in 2011. The nine-member expert committee has been working on reviewing new medical evidence and writing revisions for several years.

The committee members released a preliminary draft of the guidelines at the AACC’s annual meeting in September. Medical Laboratory Observer describes some of those recommendations and the overall guideline-review process in an article in this issue.

As you know, standardization of diagnostic methods and measures ensures that a patient will get the same result no matter what lab performs the testing. In fact, the idea of standardization that is based on medical evidence is a central tenant of the healthcare industry’s efforts to improve the quality of patient care.

Committee members have put in many volunteer hours so far: about a month of 40-hour work weeks, according to the estimate of one committee member. It is important work, and I am glad that this group has agreed to undertake this endeavor.

Committee Chairperson David B. Sacks, MB ChB, FACP, FRCPath, Adjunct Professor of Medicine, Georgetown University and Clinical Professor of Pathology, George Washington University, told me he cannot predict when the preliminary guidelines will be in final form. The COVID-19 pandemic has slowed forward momentum in this project — just as it has for so many others.

I urge all of you to learn about the preliminary guidelines. You will have an opportunity to submit comments at some point in the process. And once the recommendations become final, you should evaluate them and consider what, if any, procedures you should update in your lab’s daily work to align with the recommendations.

I welcome your comments, questions, and opinions – please send them to me at [email protected].