Diabetes is a growing problem in the United States. The number of people diagnosed with the disease continues to climb (currently at 16 million), and the costs of care are rising as well (estimated in 1992 to be $98 billion), both for treating acute conditions and more serious complications. Diabetes has also been linked to other prevalent conditions, including obesity and heart disease. Because of these concerns and the wide variety of laboratory tests being marketed for use in diabetes (its diagnosis, management, and daily home monitoring by patients on insulin therapy), the NACB decided these guidelines of “best practices” were needed.

The guidelines were developed by a panel of experts and then reviewed by the Professional Practice Committee of the American Diabetes Association. They were then presented at American Association for Clinical Chemistry’s July 2000 annual meeting; comments received during this presentation were used to further refine the guidelines.

Highlights of the guidelines are as follows:

• Fasting plasma glucose remains the sole diagnostic criteria for diabetes and is useful in screening high-risk individuals for the disease but not for routine monitoring or therapy evaluation.
• Portable meters are recommended for self-monitoring of blood glucose for those patients on insulin, but not for diagnosis or screening due to their imprecision and variability among the different meters available.
• Glycated hemoglobin (GHb or A1C) should be measured at least twice a year in all patients with diabetes to document glycemic control (with the goal of keeping GHb levels below 7%) using an assay certified by the National Glycohemoglobin Standardization Program.
• An annual lipid profile is recommended for all adults with diabetes because of the increased risk of heart disease.

The guidelines are published in the March 2002 issue of Clinical Chemistry. In addition, there is a cover story in the March issue of Clinical Laboratory News. The ADA will also be publishing the guidelines in an upcoming issue of Diabetes Care.

Sources
Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, and Parrott M. “Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.” Clinical Chemistry, March 2002, 48(3):436-472. http://www.clinchem.org/cgi/content/full/48/3/436

Sainato, David. “NACB Issues Guidelines for Lab Testing in Diabetes: Reaffirm Value of Glucose, GHb, and Lipid Determinations.” Clinical Laboratory News, March 2002, 28(3):1,8-9.

American Diabetes Association, Facts and Figures