EDUCATION :: DIABETES
Advancing diabetes care with updated testing guidelines
By Linda Wilson T
he American Society for Clinical Chemistry (AACC) and the American Diabetes Association (ADA) are updating their evidence-based clinical guidelines for diagnosing and monitoring diabetes. Some of the major areas of revisions or additions involve preserving glucose levels in blood samples, testing in pregnant and postpartum women, the use of continuous glucose meters and managing interferences to HbA1c test results. The guidelines promote the standardization of testing practic-
es, explains, David E. Bruns, MD, Pathologist and Professor Emer- itus at the University of Virginia Medical Center, Charlottesville, and a member of the guidelines committee. “In the area of diagnosis, I think that standardization of the techniques is absolutely crucial, so that we don’t have people being diagnosed with diabetes by different criteria.” The testing guidelines were published previously in 2002 and 2011 in Clinical Chemistry and Diabetes Care. All nine
David E. Bruns, MD
members of the expert committee involved in the 2011 iteration of the guidelines are working on the current effort. While all guidelines are important, this is particularly true
for diabetes testing because it is such a common disease. 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.1 It’s important to not only produce guidelines but to review
and revise them regularly. “These guidelines have to be updated regularly as knowledge advances and lab tests improve and management of patients with diabetes improves,” explains David Sacks MB, ChB, FRCPath, Adjunct Professor of Medicine, Georgetown University; Clinical Professor of Pathology, George Washington University; and committee chairperson.
Methodical process However, the process of updating the diabetes testing guidelines is methodical and laborious, and draft recommendations go through multiple layers of vetting before they become final. Work on the current iteration began several years ago but has been stymied by the fallout from the COVID-19 pandemic, Sacks said, adding that he did not want to provide a guesstimate on when the guidelines would be in final form. The process begins with a committee comprised of experts from both the AACC and ADA. After reviewing and inter- preting new medical literature, committee members draft updated recommendations, which are then graded based on the strength of the recommendation and the quality of the evidence supporting it. A grading system was developed during the 2011 cycle, and the committee is using it during the current guideline-drafting effort, Sacks said. The rating scale ranges from high to very low, and it is described in detail in the 2011 articles.2
The guidelines 24 DECEMBER 2021
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Continuous glucose meters are not appropriate for the diagnosis of diabetes, but they can be useful in helping people with diabetes manage the disease.
also include “good practice” recommendations, which are based on expert consensus rather than high-quality clinical evidence from randomized, controlled studies. Once the committee members draft and grade the guidelines,
they post them on the internet for public comment; they then revise the guidelines based on that feedback. After that, the AACC Evidence Based Lab Medicine Subcommittee and the ADA Professional Practice Committee review the guidelines, which are then sent to peer review before they are finalized, Sacks explains. As of now, the committee is finalizing a set of draft guidelines,
which it will post online. In the meantime, Sacks and several other members of the committee spoke about the process and the draft recommendations during an educational session at AACC’s 2021 annual meeting, which occurred in September in Atlanta. There are numerous areas of the draft guidelines — and
Sacks is careful to emphasize their preliminary status — that the committee emphasized during the AACC presentation.
Glycolysis
One example is how to prevent the loss of glucose in blood samples, which occurs as a result of glycolysis, or the process of converting glucose into compounds that generate energy. To counter that problem, the committee in the 2011 guidelines recommended that lab employees immediately place the sample in an ice-water slurry and subject it to centrifugation to remove the cells within 15-30 minutes. If that wasn’t possible, the com- mittee suggested that labs use a tube containing a glycolytic inhibitor, such as granulated citrate buffer. However, in the preliminary 2021 guidelines, the committee
reversed those recommendations, and now says a test tube containing a glycolytic inhibitor is the best choice. The recom- mendation also says that tubes with only enolase inhibitors,
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