Paul R. Conlin, MD; Jeffrey Colburn, MD; David Aron, MD, MS; Rose Mary Pries, DrPH; Mark P. Tschanz, DO; Leonard Pogach, MD, MBA
Disclaimer: The views expressed in this article are not to be construed as those of the U.S. Department of Veterans Affairs or the U.S. Department of Defense.
Acknowledgment: The authors thank the participants of the VA/DoD working group for their commitment to advancing evidence-based care for diabetes (see Appendix G of the CPG ) and the patient focus group for their valuable insights into the care we provide them.
Financial Support: Development of the VA/DoD CPG was supported by the Office of Quality, Safety and Value of the U.S. Department of Veterans Affairs.
Disclosures: Dr. Aron reports a grant from the U.S. Department of Veterans Affairs Health Services Research and Development Service during the conduct of the study and is a member of the quality measures committee of the Endocrine Society. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-1362.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Leonard Pogach, MD, MBA, Veterans Affairs Central Office, Office of Specialty Care (P11), 810 Vermont Avenue, Washington, DC 20420; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Conlin: Chief, Medical Service, VA Boston Healthcare System, 1400 VFW Parkway, West Roxbury, MA 02132.
Dr. Colburn: Staff Endocrinologist, San Antonio Military Medical Center, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, TX 78234-4504.
Dr. Aron: Director, Clinical Program Research and Evaluation, Louis Stokes Cleveland VA Medical Center, Administrative Building EUL 5M677, 10701 East Boulevard, Cleveland, OH 44106.
Dr. Pries: National Program Manager, Veterans Health Education Program, VHA National Center for Health Promotion and Disease Prevention (10P4N), Office of Patient Care Services, 3022 Croasdaile, Suite 200, Durham, NC 27705.
Dr. Tschanz: Associate Program Director, Naval Medical Center San Diego, Internal Medicine, Building 3/3, 34800 Bob Wilson Drive, San Diego, CA 92134.
Dr. Pogach: National Director, Medicine, Veterans Affairs Central Office, Office of Specialty Care Services (P11), 810 Vermont Avenue, Washington, DC 20420.
Author Contributions: Conception and design: P.R. Conlin, J. Colburn, D. Aron, R.M. Pries, M.P. Tschanz, L. Pogach.
Analysis and interpretation of the data: P.R. Conlin, J. Colburn, D. Aron, R.M. Pries, M.P. Tschanz, L. Pogach.
Drafting of the article: P.R. Conlin, J. Colburn, D. Aron, R.M. Pries, M.P. Tschanz, L. Pogach.
Critical revision of the article for important intellectual content: P.R. Conlin, J. Colburn, D. Aron, R.M. Pries, M.P. Tschanz, L. Pogach.
Final approval of the article: P.R. Conlin, J. Colburn, D. Aron, R.M. Pries, M.P. Tschanz, L. Pogach.
Provision of study materials or patients: J. Colburn.
In April 2017, the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) approved a joint clinical practice guideline for the management of type 2 diabetes mellitus.
The VA/DoD Evidence-Based Practice Work Group convened a joint VA/DoD guideline development effort that included a multidisciplinary panel of practicing clinician stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions in collaboration with the ECRI Institute, which systematically searched and evaluated the literature through June 2016, developed an algorithm, and rated recommendations by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.
This synopsis summarizes key features of the guideline in 7 areas: patient-centered care and shared decision making, glycemic biomarkers, hemoglobin A1c target ranges, individualized treatment plans, outpatient pharmacologic treatment, glucose targets for critically ill patients, and treatment of hospitalized patients.
Table. Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus
Algorithmic approach to evaluating glycemic control risk factors, setting a personalized glycemic control target range, providing self-management (including lifestyle and nutrition) education, and initiating or reevaluating medication therapy.
In this video, Paul R. Conlin, MD, offers additional insight into the article, "Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus."
Clayton R. Wilburn, MD, Andrew J. Goodwin, MD, and Michael R. Lewis, MD, MBA
Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont
December 6, 2017
Comment on: Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus
We commend Conlin and colleagues for highlighting in their guideline (1) the limitations of using a single HbA1c measurement to make treatment decisions without incorporating all of the clinical context and additional findings. The authors state that point-of-care (POC) HbA1c testing is not subject to systematic quality oversight, but this is not always the case. POC testing falls under two categories defined by the FDA based on the complexity of the testing: waived (e.g., capillary blood glucose) or non-waived (e.g., cardiac troponin). POC testing in the medical setting is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (2). For outpatient clinics or other sites that perform only waived POC testing, a certificate of waiver can be obtained which requires the site only to follow the manufacturer’s operating guidelines and requires little quality oversight. Increasingly, outpatient clinics are components of healthcare systems in which administration and oversight of POC testing is provided by pathologists serving as CLIA laboratory directors. As a CLIA laboratory director, a pathologist implements the testing guidelines and quality management requirements promulgated by the Clinical and Laboratory Standards Institute (3) and the CLIA-approved accreditation organization that routinely inspects the laboratory, such as The Joint Commission or the College of American Pathologists (CAP) (4). The laboratory director of a CAP-accredited POC testing site ensures that a quality management program is in place to continuously evaluate test performance, that personnel performing testing have the appropriate training and qualifications, and that new POC test methods have been validated. In a CAP-accredited laboratory, the validation requirements for waived POC tests are set by the CLIA laboratory director and often, as in our practice at the University of Vermont Medical Center (UVMMC), exceed the manufacturer’s requirements. For a waived POC test, CAP requires that quality controls be run each day of patient testing and that the laboratory director reviews those results at minimum on a monthly basis. Like many of our laboratory director colleagues, we ensure that our laboratory participates in semi-annual CAP-sponsored accuracy and linearity surveys to further ensure the accuracy of POC testing systems. We want to remind the readers of the Annals that their pathologist colleagues serving as CLIA laboratory directors are constantly monitoring the quality of the testing they oversee and are always available as clinical and technical consultants and collaborators.References: 1. Conlin PR, Colburn J, Aron D, Pries RM, Tschanz MP, Pogach L. Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus. Ann Intern Med. 2017;167(9):655-63. 2. Clinical Laboratory Improvement Amendments (CLIA) [internet]. Baltimore: Centers for Medicare and Medicaid Services (CMS); 2017 [cited 2017 Dec 05]. Available from: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html3. Clinical Laboratory and Standards Institute (CLSI). Quality management: approaches to reducing errors at the point of care; approved guideline. CLSI document POCT07-A. Wayne (PA): CLSI; 2010.4. Commission on Laboratory Accreditation, College of American Pathologists (CAP). Laboratory accreditation program all common checklist. Northfield (IL): CAP, 2017.
Conlin PR, Colburn J, Aron D, et al. Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus. Ann Intern Med. 2017;167:655–663. [Epub ahead of print 24 October 2017]. doi: https://doi.org/10.7326/M17-1362
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Published: Ann Intern Med. 2017;167(9):655-663.
Published at www.annals.org on 24 October 2017
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism, Guidelines.
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