Comparison of Blood Glucose Measurements Using Samples Obtained from the Forearm, Finger Skin Puncture, and Venous Serum
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background : Blood glucose testing (BGT) at the forearm minimizes the pain experienced during sampling of capillary blood. We compared the BGT results for forearm sampling with those for standard finger skin puncture and venous serum to evaluate the clinical validity of forearm BGT. Methods : BGT was performed on the finger (GF) and forearm (GA) with a portable glucometer in 555 subjects, including 61 diabetic patients, under fasting conditions. BGT with venous serum (GV) was followed within an hour in 514 subjects. Simple linear regression, intraclass correlation, and Passing-Bablok regression analyses were performed using the GA-GF and GA-GV data. Results : GA showed an excellent linear relationship with both GF and GV with a Pearson correlation coefficient (r) of 0.97 (P<0.0001) in the patient group, which was similar to the findings in the normal group except for the lower r values. The mean bias between GA and GF and between GA and GV were within ±10 mg/dL in both groups. The intraclass correlation coefficients were slightly smaller than the corresponding r values, but they showed the same tendency in both groups. In the Passing-Bablok analyses, the 95% confidence intervals of the slope and intercept parameters were <±20% of unity and <±20 mg/dL, respectively, which were within the acceptable ranges. All 3 statistical analyses supported the satisfactory agreement of GA with GF or GV. Conclusions : BGT at the forearm was highly consistent with the standard BGT, thereby confirming its applicability in clinical practice for self-testing under steady fasting conditions. (Korean J Lab Med 2010;30:264-75)
Abstract
Background : Blood glucose testing (BGT) at the forearm minimizes the pain experienced during sampling of capillary blood. We compared the BGT results for forearm sampling with those for standard finger skin puncture and venous serum to evaluate the clinical validity of forearm BGT. Methods : BGT was performed on the finger (GF) and forearm (GA) with a portable glucometer in 555 subjects, including 61 diabetic patients, under fasting conditions. BGT with venous serum (GV) was followed within an hour in 514 subjects. Simple linear regression, intraclass correlation, and Passing-Bablok regression analyses were performed using the GA-GF and GA-GV data. Results : GA showed an excellent linear relationship with both GF and GV with a Pearson correlation coefficient (r) of 0.97 (P<0.0001) in the patient group, which was similar to the findings in the normal group except for the lower r values. The mean bias between GA and GF and between GA and GV were within ±10 mg/dL in both groups. The intraclass correlation coefficients were slightly smaller than the corresponding r values, but they showed the same tendency in both groups. In the Passing-Bablok analyses, the 95% confidence intervals of the slope and intercept parameters were <±20% of unity and <±20 mg/dL, respectively, which were within the acceptable ranges. All 3 statistical analyses supported the satisfactory agreement of GA with GF or GV. Conclusions : BGT at the forearm was highly consistent with the standard BGT, thereby confirming its applicability in clinical practice for self-testing under steady fasting conditions. (Korean J Lab Med 2010;30:264-75)
참고문헌 (38)
- Zimmet P, "Global and societal implications of the diabetes epidemic", Nature, 414, pp.782~787 (2001)
- Kim MH, "Educational disparities in the metabolic syndrome in a rapidly changing society: the case of South Korea", Int J Epidemiol, 34, pp.1266~1273 (2005)
- Cho NH, "Diabetes epidemiology in Korean", J Korean Diabetes Assoc, 25, pp.1~10 (2001)
- Korea National Statistical Office, "Annual report on the cause of death statistics (based on vital registration) 2006", Statstice Korea, ~ (2007)
- Kim EJ, "Diabetics. 3rd ed", pp.1~ (2005), Korea Medical Book Company
- Parchman ML, "Continuity of care, self-management behaviors, and glucose control in patients with type 2 diabetes", Med Care, 40, pp.137~144 (2002)
- Kim EJ, "Diabetics. 2nd ed", pp.303~308 (1998), Korea Medical Book Company
- Skyler JS, "Self-monitoring of blood glucose", Med Clin North Am, 66, pp.1227~1250 (1982)
- 최자윤, "당뇨환자와 일반인의 혈당검사 방법 별 지각된 통증정도에 대한 비교", Journal of Korean Academy of Nursing, 33(8), pp.928~935 (2003), 한국간호과학회
- Park SW, "Current status of diabetes management in Korea using national insurance database", Korean Diabetes Association 19th Spring Meeting, pp.227~228 (2006)
- Cowett RM, "Capillary (heelstick) versus venous blood sampling for the determination of glucose concentration in the neonate", Biol Neonate, 62, pp.32~36 (1992)
- Barker DP, "Exposure to invasive procedures in neonatal intensive care unit admissions", Arch Dis Child Fetal Neonatal Ed, 72, pp.F47~F48 (1995)
- McIntosh N, "Alleviation of the pain of heel prick in preterm infants", Arch Dis Child Fetal Neonatal Ed, 70, pp.F177~F181 (1994)
- Cunningham DD, "Vacuum-assisted lancing of the forearm: an effective and less painful approach to blood glucose monitoring", Diabetes Technol Ther, 2, pp.541~548 (2000)
- 박미숙, "전완부위 최소통증 채혈을 위한 진공 자동 채혈기법", 의공학회지, 25(6), pp.18~18 (2004), 대한의용생체공학회
- Lock JP, "Anagnostopoulos A. Whole-blood glucose testing at alternate sites: glucose values and hematocrit of capillary blood drawn from fingertip and forearm", Diabetes Care, 25, pp.337~341 (2002)
- Cohen M, "A comparison of blood glucose meters in Australia", Diabetes Res Clin Pract, 71, pp.113~118 (2006)
- Reinauer H, "Laboratory diagnosis and monitoring of diabetes mellitus", pp.11~12 (2002), World Health Organization
- U. S. Food and Drug Administration, "Review criteria for assessment of portable blood glucose monitoring in-vitro diagnostic devices using glucose oxidase, dehydrogenase, or hexokinase methodology. Guidance document (medical devices)", U. S. Department of Health and Human Service, 5~ (1997)
- Koch GG, "Intraclass correlation coefficient in Encyclopedia of statistical sciences", pp.213~217 (1982), John Wiley & Sons
- Passing H, "A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I", J Clin Chem Clin Biochem, 21, pp.709~720 (1983)
- National Committee for Clinical Laboratory Standards, "Point-of-care blood glucose testing in acute and chronic care facilities: approved guideline. Document C30-A2. 2nd ed", pp.22~ (2002), NCCLS
- International Organization for Standardization, "ISO 15197:2003. In vitro diagnostic test systems requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus", International Organization for Standardization, ~ (2003)
- Clarke WL, "Evaluating clinical accuracy of systems for self-monitoring of blood glucose", Diabetes Care, 10, pp.622~628 (1987)
- Kim DK, "Basic investigation for the non-invasive measurement of blood glucose concentrations by millimeter waves", IEEK Journal (SC), 42, pp.3~6 (1998)
- Waynant RW, "Overview of non-invasive fluid glucose measurement using optical techniques to maintain glucose control in diabetes mellitus", LEOS newsletter, 12, pp.3~6 (1998)
- Paul EK, "Carbohydrates in Clinical diagnosis and management by laboratory methods", pp.214~ (2001), WB Sanders
- 권민정, "혈당측정기 GLUCOCARD X-METER 평가", The Korean Journal of Laboratory Medicine, 28(1), pp.8~15 (2008), 대한진단검사의학회
- Jungheim K, "Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection", Diabetes Care, 25, pp.956~960 (2002)
- Jungheim K, "Risky delay of hypoglycemia detection by glucose monitoring at the arm", Diabetes Care, 24, pp.1303~1306 (2001)
- Ellison JM, "Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites", Diabetes Care, 25, pp.961~964 (2002)
- Fagrell B, "Microcirculation of the skin. In the physiology and pharmacology of the microcirculation", pp.133~180 (1984), Academic Press
- Rendell M, "Microvascular blood flow, volume, and velocity measured by laser Doppler techniques in IDDM", Diabetes, 38, pp.819~824 (1989)
- Stansberry KB, "Primary nociceptive afferents mediate the blood flow dysfunction in non-glabrous (hairy) skin of type 2 diabetes: a new model for the pathogenesis of microvascular dysfunction", Diabetes Care, 22, pp.1549~1554 (1999)
- McGarraugh G, "Response to Jungheim and Koschinsky: glucose monitoring at the arm", Diabetes Care, 24, pp.1304~1306 (2001)
- Pohl SL, "Self-measurement of blood glucose concentration: clinical significance of patient-generated measurements", Diabetes Care, 8, pp.617~619 (1985)
- Tieszen KL, "Alternate site blood glucose testing: do patients prefer it?", Diabet Med, 20, pp.325~328 (2003)
- Dai KS, "Accuracy of the EasyTouch blood glucose self-monitoring system: a study of 516 cases", Clin Chim Acta, 319, pp.135~141 (2004)