title: PRIDE Statement on the Need for a Moratorium on the CMS Plan to Cite Hospitals for Performing Point-of-Care Capillary Blood Glucose Monitoring on Critically Ill Patients.
abstract: OBJECTIVE
  A writing committee of the Planning Research in Inpatient Diabetes (PRIDE) group has written this consensus article on behalf of the group in response to a specific request for input from the Centers for Medicare and Medicaid Services (CMS). The purpose of this article is to respond to the March 13, 2015 statement from that agency regarding plans to enforce prohibition of the off-label use of point of care (POC) capillary blood glucose monitor (BGM) testing in most critically ill patients. The article discusses: 1) how POC BGM testing is currently regulated; 2) how POC BGM testing is currently used in the United States; and 3) how POC BGM testing can be safely and effectively regulated in the future through cooperation between the clinician, laboratory, regulatory, industry, and patient communities.
  
  
  METHODS
  Nine members of PRIDE volunteered to write the statement on behalf of the entire group.
  
  
  METHODS
  Descriptions of current medical practice for critically ill patients were derived from the experience of the authors. Descriptions of the performance of various methods for measuring glucose levels for intensive insulin therapy came from a literature review.
  
  
  METHODS
  Eleven questions were developed by the PRIDE writing group. After extensive electronic and telephone discussion, the article was written and reviewed by all nine authors and then reviewed by two outside experts in the care of critically ill patients. All suggestions by the authors and the outside experts were incorporated.
  
  
  CONCLUSIONS
  Although the CMS is attempting to protect patients with abnormal glycemic control from harm due to inaccurate POC fingerstick capillary BGM testing, their plan will result in more harm than good. A moratorium on enforcement of the prohibition of off-label use of POC capillary BGM testing is needed.
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: David C
authors.initials: DC
authors.lastname: Klonoff
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Boris
authors.initials: B
authors.lastname: Draznin
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Andjela
authors.initials: A
authors.lastname: Drincic
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Dungan
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Roma
authors.initials: R
authors.lastname: Gianchandani
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Silvio E
authors.initials: SE
authors.lastname: Inzucchi
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: James H
authors.initials: JH
authors.lastname: Nichols
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Rice
authors.affiliation: Diabetes Research Institute (D.C.K.), Mills-Peninsula Health Services, San Mateo, California 94401; University of Colorado Denver, School of Medicine (B.D.), Aurora, Colorado 80045; The Nebraska Medical Center Diabetes Center (A.D.), Omaha, Nebraska 68198; The Ohio State University (K.D.), Columbus, Ohio 43210; University of Michigan (R.G.), Ann Arbor, Michigan 48109; Yale University School of Medicine (S.E.I.), New Haven, Connecticut 06510; Vanderbilt University School of Medicine (J.H.N., M.J.R.), Nashville, Tennessee 37232; and New York-Presbyterian Hospital/Weill Cornell Medical College (J.J.S.), New York, New York 10065.
authors.forename: Jane Jeffrie
authors.initials: JJ
authors.lastname: Seley
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D014487:Centers for Medicare and Medicaid Services, U.S.; D032921:Consensus; D016638:Critical Illness / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D006301:Health Services Needs and Demand; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods*; D056687:Off-Label Use; D019095:Point-of-Care Systems; D014481:United States
chemical_list: D001786:Blood Glucose