ADA Releases Guidance on Use of Laboratory Analysis in Diagnosis, Management of Diabetes

Robert Gabbay, MD, PhD
Credit: LinkedIn

The American Diabetes Association (ADA) has released new guidance for the use of laboratory analysis in the diagnosis and management of diabetes.

Released jointly with the American Association of Clinical Chemistry (AACC), the document was created to provide guidance aimed at streamlining the diagnostic process, standardizing laboratory procedures, and ensuring people with diabetes receive the most comprehensive and accurate care.^1,2

"Scientific advances, particularly in the field of laboratory diagnostics, have necessitated a reassessment of our existing guidelines,” said Robert Gabbay, MD, PhD, the chief scientific and medical officer of the ADA. “Our goal with these updates is to empower healthcare providers with the latest tools and knowledge for accurate, early diagnosis, and optimal management of diabetes."

In the past decade, even dating back to the turn of the century, few fields with such immense public health implications have seen the level of interest and scientific advancement as the management of diabetes. Despite these advances in technology, pharmacotherapies, and management practices, the community has encountered major hurdles in their pursuit of optimized care, namely the increasing prevalence of both type 1 and type 2 diabetes.^3,4

Approved by the AACC’s Evidence Based Laboratory Medicine Subcommittee in January 2023, the AACC Academy Council in February 2023, the AACC Board of Directors in March 2023, and the ADA in March 2023, the document, titled “Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus,”, was simultaneously published in Diabetes Care and Clinical Chemistry. At 49 pages in length and citing more than 500 references, the document represents both organization’s latest efforts at streamlining diagnosis and management of diabetes.^1,2

The document itself contains dozens of recommendations, ranging in strength from strongly recommended to good practice to point, across 12 aspects of diagnosis and management. These 12 aspects include glucose, glucose meters, continuous glucose monitoring, noninvasive glucose sensing, gestational diabetes mellitus, urine glucose, ketone testing, HbA1c, genetic markers, autoimmune markers, urine albumin, and miscellaneous potentially important analytes.^1,2

Some of the highest strength recommendations from within the document are highlighted below:^1,2

• Fasting glucose should be measured in venous plasma when used to establish the diagnosis of diabetes, with a value >7.0mmol/L diagnostic of diabetes. Strongly Recommended; High Quality Evidence
• Routine use of blood glucose monitoring is not recommended for people with type 2 diabetes treated with diet and/or oral agents alone. Strongly Recommended; High Quality Evidence
• Real-time CGM should be used in conjunction with insulin as a tool to lower HbA1c concentrations and/or reduce hypoglycemia in teens and adults with type 1 diabetes who are not meeting glycemic targets or have hypoglycemia unawareness and/or episodes of hypoglycemia. Strongly Recommended; High Quality Evidence
• All pregnant women not previously known to have diabetes should be evaluated for gestational diabetes mellitus at 24 to 28 weeks of gestation. Strongly Recommended; High Quality Evidence
• Annual testing for albuminuria should begin in pubertal or post-pubertal individuals 5 years after diagnosis of type 1 diabetes and at the time of diagnosis of type 2 diabetes, regardless of treatment. Strongly Recommended; High Quality Evidence
• Urine albumin should be measured annually in adults with diabetes using morning spot urine albumin-to-creatinine ratio. Strongly Recommended; High Quality Evidence

"Applying this new guidance not only enhances diagnostic accuracy but also aids in risk stratification as well as helping clinicians tailor treatment plans,” said Nuha El Sayed, MD, MMSc, vice president of Healthcare Improvement and chair of the Professional Practice Committee of the ADA.

References:

1. Sacks DB, Arnold M, Bakris GL, et al. Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus [published online ahead of print, 2023 Jul 20]. Diabetes Care. 2023;dci230036. doi:10.2337/dci23-0036
2. Sacks DB, Arnold M, Bakris GL, et al. Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus [published online ahead of print, 2023 Jul 20]. Diabetes Care. 2023;dci230048. doi:10.2337/dci23-0048
3. Campbell P. Study forecasts number of people with type 1 diabetes to double by 2040. HCP Live. September 21, 2022. Accessed July 25, 2023. https://www.hcplive.com/view/study-number-of-people-with-type-1-diabetes-to-double-by-2040.
4. GBD 2021 Diabetes Collaborators. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;402(10397):203-234. doi:10.1016/S0140-6736(23)01301-6