Point-of-care HbA1c testing with the a1cnow test kit in general practice dental clinics: A pilot study involving its accuracy and practical issues in its use

Point of Care

Volumn 13, Issue 4, 2014, Pages 142-147

  Strauss, Shiela M ^a   Rosedale, Mary ^a   Pesce, Michael A ^b   Juterbock, Caroline ^c   Kaur, Navjot ^a   DePaola, Joe ^a   Goetz, Deborah ^c   Wolff, Mark S ^d   Malaspina, Dolores ^c   Danoff, Ann ^c,e  

^a NEW YORK UNIVERSITY   (United States)

^b Department of Medicine   (United States)

^c NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^d NEW YORK UNIVERSITY COLLEGE OF DENTISTRY   (United States)

^e DEPARTMENT OF VETERANS AFFAIRS   (United States)

Author keywords

A1c; Dental visit; Diabetes screening; Point of care

Indexed keywords

EID: 84925298770     PISSN: 1533029X     EISSN: 15330303     Source Type: Journal    
DOI: 10.1097/POC.0000000000000039     Document Type: Article

References (59)

1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet 2011. National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011. Available at: www.cdc.gov/diabetes/ pubs/pdf/ndfs-2011.pdf. Accessed February 16, 2014.
2. Boyle JP, Thompson TJ, Gregg EW, et al. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010;8:29.
3. Harris MI, Klein R, Welborn TA, et al. Onset of NIDDM occurs at least 4-7 yr before clinical diagnosis. Diabetes Care. 1992;15(7):815-819.
4. U.K. Prospective Diabetes Group. U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995;44(11):1249-1258.
5. American Diabetes Association. Standards of medical care in diabetes-2013. Diabetes Care. 2013;36(Suppl 1:S11-S66.
6. Harris MI, Eastman RC. Early detection of undiagnosed diabetes mellitus: a US perspective. Diabetes Metab Res Rev. 2000;16(4):230-236.
7. Diabetes Prevention Program Research Group. The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the Diabetes Prevention Program. Diabet Med. 2007;24(2):137-144.
8. Sumner CJ, Sheth S, Griffin JW, et al. The spectrum of neuropathy in diabetes and impaired glucose tolerance. Neurology. 2003;60(1):108-111.
9. Herman WH. Diabetes epidemiology: guiding clinical and public health practice: the Kelly West Award Lecture, 2006. Diabetes Care. 2007;30(7):1912-1919.
10. Barrett-Connor E, Ferrara A. Isolated postchallenge hyperglycemia and the risk of fatal cardiovascular disease in older women and men. The Rancho Bernardo Study. Diabetes Care. 1998;21(8):1236-1239.
11. Haffner SM, Lehto S, Rönnemaa T, et al. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;339(4):229-234.
12. Adler AI, Neil HA, Manley SE, et al. Hyperglycemia and hyperinsulinemia at diagnosis of diabetes and their association with subsequent cardiovascular disease in the United Kingdom prospective diabetes study (UKPDS 47). Am Heart J. 1999;138(5 Pt 1):S353-S359.
13. The DECODE Study Group. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. The DECODE study group. European Diabetes Epidemiology Group. Diabetes Epidemiology: collaborative analysis of diagnostic criteria in Europe. Lancet. 1999;354(9179):617-621.
14. Nathan DM, Cleary PA, Backlund JY, et al. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353(25):2643-2653.
15. Barr EL, Zimmet PZ, Welborn TA, et al. Risk of cardiovascular and all-cause mortality in individuals with diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance: the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab). Circulation. 2007;116(2):151-157.
16. Borch-Johnsen K, Lauritzen T, Glümer C, et al. Screening for Type 2 diabetes-should it be now? Diabet Med. 2003;20(3):175-181.
17. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998;15(7):539-553.
18. Diabetes UK. Position Statement. Early Identification of People With Type 2 Diabetes. 2012. Available at: http://www.diabetes.org.uk/Documents/ Position%20statements/diabetes-uk-position-statement-early-identification-type-2-0513.pdf. Accessed February 16, 2014.
19. Diabetes Australia. National Evidence-Based Guideline for Case Detection and Diagnosis of Type 2 Diabetes, Part 3, Case Detection and Diagnosis. 2001. Available at: http://www.nhmrc.gov.au/-files-nhmrc/file/ publications/synopses/di9.pdf. Accessed February 16, 2014.
20. Wareham NJ, Griffin SJ. Should we screen for type 2 diabetes? Evaluation against National Screening Committee criteria. BMJ. 2001;322(7292):986-988.
21. Ginde AA, Delaney KE, Lieberman RM, et al. Estimated risk for undiagnosed diabetes in the emergency department: a multicenter survey. Acad Emerg Med. 2007;14(5):492-495.
22. Silverman RA, Pahk R, Carbone M, et al. The relationship of plasma glucose and HbA1c Levels among emergency department patients with no prior history of diabetes mellitus. Acad Emerg Med. 2006;13(7):722-726.
23. Howse JH, Jones S, Hungin AP. Screening for diabetes in optometry practices: acceptability to users. Ophthalmic Physiol Opt. 2011;31(4):367-374.
24. Snella KA, Canales AE, Irons BK, et al. Pharmacy-and community-based screenings for diabetes and cardiovascular conditions in high-risk individuals. J Am Pharm Assoc. 2006;46(3):370-377.
25. Hein C. Scottsdale revisited: the role of dental practitioners in screening for undiagnosed diabetes and the medical co-management of patients with diabetes or those at risk for diabetes. Compend Contin Educ Dent. 2008;29(9):538-540, 542-544, 546-553.
26. Grossi SG, Genco RJ. Periodontal disease and diabetes mellitus: a two-way relationship. Ann Periodontol. 1998;3(1):51-61.
27. Mealey BL, Rethman MP. Periodontal disease and diabetes mellitus. Bidirectional relationship. Dent Today. 2003;22(4):107-113.
28. Mealey BL. Periodontal disease and diabetes. A two-way street. J Am Dent Assoc. 2006;137(Suppl 2):26S-31S.
29. Taylor GW. Bidirectional interrelationships between diabetes and periodontal diseases: an epidemiologic perspective. Ann Periodontol. 2001;6(1):99-112.
30. Sutherland JH, Taylor GW, Offenbacher S. Diabetes and periodontal infection: making the connection. Clin Diabetes. 2005;23:171-178.
31. Barasch A, Gilbert GH, Spurlock N, et al. DPBRN Collaborative Group. Random plasma glucose values measured in community dental practices: findings from the Dental Practice-Based Research Network. Clin Oral Investig. 2013;17(5):1383-1388.
32. Borrell LN, Kunzel C, Lamster I, et al. Diabetes in the dental office: using NHANES III to estimate the probability of undiagnosed disease. J Periodontal Res. 2007;42(6):559-565.
33. Greenberg BL, Glick M. Assessing systemic disease risk in a dental setting: a public health perspective. Dent Clin North Am. 2012;56(4):863-874.
34. Strauss SM, Russell S, Wheeler A, et al. The dental office visit as a potential opportunity for diabetes screening: an analysis using NHANES 2003-2004 data. J Public Health Dent. 2010;70(2):156-162.
35. Glümer C, Carstensen B, Sandbaek A, et al. A Danish diabetes risk score for targeted screening: the Inter99 study. Diabetes Care. 2004;27(3):727-733.
36. Griffin SJ, Little PS, Hales CN, et al. Diabetes risk score: towards earlier detection of type 2 diabetes in general practice. Diabetes Metab Res Rev. 2000;16(3):164-171.
37. Lindström J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003;26(3):725-731.
38. Ginde AA, Cagliero E, Nathan DM, et al. Value of risk stratification to increase the predictive validity of HbA1c in screening for undiagnosed diabetes in the US population. J Gen Intern Med. 2008;23(9):1346-1353.
39. Magee MF, Nassar C. Hemoglobin A1c testing in an emergency department. J Diabetes Sci Technol. 2011;5(6):1437-1443.
40. Papastergiou J, Rajan A, Diamantouros A, et al. HbA1c testing in the community pharmacy: a new strategy to improve care for patients with diabetes. Can Pharm J (Ott). 2012;145(4):165-167.
41. Al Hamarneh YN, Rosenthal M, Tsuyuki RT. Glycemic control in community-dwelling patients with type 2 diabetes. Can Pharm J (Ott). 2012;145(2):68-69.
42. Leal S, Soto-Rowen M. Usefulness of point-of-care testing in the treatment of diabetes in an underserved population. J Diabetes Sci Technol. 2009;3 (4):672-676.
43. Bode BW, Irvin BR, Pierce JA, et al. Advances in hemoglobin A1c point of care technology. J Diabetes Sci Technol. 2007;1(3):405-411.
44. Kennedy L, Herman WH, GOAL A1C Study Team. Glycated hemoglobin assessment in clinical practice: comparison of the A1cNow point-of-care device with central laboratory testing (GOAL A1C Study). Diabetes Technol Ther. 2005;7(6):907-912.
45. Sicard DA, Taylor JR. Comparison of point-of-care HbA1c test versus standardized laboratory testing. Ann Pharmacother. 2005;39(6):1024-1028.
46. Schwartz KL, Monsur JC, Bartoces MG, et al. Correlation of same-visit HbA1c test with laboratory-based measurements: a MetroNet study. BMC Fam Pract. 2005;6:28.
47. St John A, Davis TM, Goodall I, et al. Nurse-based evaluation of point-of-care assays for glycated haemoglobin. Clin Chim Acta. 2006;365(1-2):257-263.
48. Lemke C, Matthaei S. The point-of-care (POC) A1cNow+ device: precision and accuracy of an improved version. Diabetes. 2009;58(Suppl 1):A111.
49. Chang A, Frank J, Knaebel J, et al. Evaluation of an over-the-counter glycated hemoglobin (A1C) test kit. J Diabetes Sci Technol. 2010;4(6):1495-1503.
50. Genco RJ, Schifferle RE, Dunford RG, et al. Screening for diabetes mellitus in dental practices: a field trial. J Am Dent Assoc. 2014;145(1):57-64.
51. D-10 Dual Program Package insert from Bio-Rad Laboratories INC. Hercules, CA 94547, Dec 2010.
52. American Diabetes Association. Standards of medical care in diabetes-2010. Diabetes Care. 2010;33(Suppl 1): S11-S61.
53. Kerbel D, Glazier R, Holzapfel S, et al. Adverse effects of screening for gestational diabetes: a prospective cohort study in Toronto, Canada. J Med Screen. 1997;4(3):128-132.
54. Meystre-Agustoni G, Paccaud F, Jeannin A, et al. Anxiety in a cohort of Swiss women participating in a mammographic screening programme. J Med Screen. 2001;8(4):213-219.
55. Wardle J, Pernet A, Collins W, et al. False positive results in ovarian cancer screening: one year follow-up of psychological status. Psychol Health. 1994;10(1): 33-40.
56. Rajan P, Nera M, Pavalura AK, et al. Comparison of glycosylated hemoglobin (HbA1C) levels in patients with chronic periodontitis and healthy controls. Dent Res J (Isfahan). 2013;10(3):389-393.
57. Wolff RE, Wolff LF, Michalowicz BS. A pilot study of glycosylated hemoglobin levels in periodontitis cases and healthy controls. J Periodontol. 2009;80(7):1057-1061.
58. Sheetz MJ, King GL. Molecular understanding of hyperglycemia's adverse effects for diabetic complications. JAMA. 2002;288(20):2579-2588.
59. Pfützner J, Hellhammer J, Musholt P, et al. Evaluation of dexterity in insulin-treated patients with type 1 and type 2 diabetes mellitus. J Diabetes Sci Technol. 2011;5(1):158-165.