دورية أكاديمية

Clinical utility of point-of-care glucose testing in the assessment of gestational diabetes: Prospective cohort study.

التفاصيل البيبلوغرافية
العنوان: Clinical utility of point-of-care glucose testing in the assessment of gestational diabetes: Prospective cohort study.
المؤلفون: Al-Hasani W; Department of Clinical Biochemistry (Synnovis), King's College Hospital NHS Foundation Trust, London, UK., Ranasinghe R; Department of Clinical Biochemistry (Synnovis), King's College Hospital NHS Foundation Trust, London, UK., Rogers H; Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK., Spanier W; Department of Clinical Biochemistry (Synnovis), King's College Hospital NHS Foundation Trust, London, UK., Spears K; Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK., Gayle C; Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK., Long L; Department of Obstetrics, King's College Hospital NHS Foundation Trust, London, UK., Dimitriadis GK; Department of Endocrinology, King's College Hospital NHS Foundation Trust, London, UK.; School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK., Hunt KF; Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.; School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK., Vincent RP; Department of Clinical Biochemistry (Synnovis), King's College Hospital NHS Foundation Trust, London, UK.; School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
المصدر: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2024 Aug; Vol. 131 (9), pp. 1270-1278. Date of Electronic Publication: 2024 Mar 18.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100935741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-0528 (Electronic) Linking ISSN: 14700328 NLM ISO Abbreviation: BJOG Subsets: MEDLINE
أسماء مطبوعة: Publication: : Oxford : Wiley-Blackwell
Original Publication: Oxford [England] : Blackwell Science, [2000]-
مواضيع طبية MeSH: Diabetes, Gestational*/diagnosis , Diabetes, Gestational*/blood , Blood Glucose*/analysis , Glucose Tolerance Test* , Point-of-Care Testing* , Sensitivity and Specificity*, Humans ; Female ; Pregnancy ; Prospective Studies ; Adult ; Predictive Value of Tests ; Point-of-Care Systems/standards
مستخلص: Objective: To assess the clinical utility of point-of-care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT).
Design: Prospective cohort study.
Setting: Antenatal clinics at King's College Hospital.
Population: Women screened for GDM between March and June 2020.
Methods: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse-It 5.40.2.
Main Outcome Measures: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method.
Results: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%-99%) and 97% (93%-98%) at fasting and 97% (91%-99%) and 79% (71%-84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%.
Conclusions: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.
(© 2024 John Wiley & Sons Ltd.)
References: Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358(19):1991–2002.
Bao W, Yeung E, Tobias DK, Hu FB, Vaag AA, Chavarro JE, et al. Long‐term risk of type 2 diabetes mellitus in relation to BMI and weight change among women with a history of gestational diabetes mellitus: a prospective cohort study. Diabetologia. 2015;58(6):1212–1219.
Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005;352(24):2477–2486.
Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009;361(14):1339–1348.
Farrar D, Simmonds M, Griffin S, Duarte A, Lawlor DA, Sculpher M, et al. The identification and treatment of women with hyperglycaemia in pregnancy: an analysis of individual participant data, systematic reviews, meta‐analyses and an economic evaluation. Health Technol Assess. 2016;20(86):1–348.
Sacks DA, Hadden DR, Maresh M, Deerochanawong C, Dyer AR, Metzger BE, et al. Frequency of gestational diabetes mellitus at collaborating centers based on IADPSG consensus panel‐recommended criteria: the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study. Diabetes Care. 2012;35(3):526–528.
Ben‐Haroush A, Yogev Y, Hod M. Epidemiology of gestational diabetes mellitus and its association with Type 2 diabetes. Diabet Med. 2004;21(2):103–113.
Diabetes in pregnancy: management from preconception to the postnatal period NICE Guideline 3. Methods, evidence and recommendations 2015.
Rebel A, Rice MA, Fahy BG. Accuracy of point‐of‐care glucose measurements. J Diabetes Sci Technol. 2012;6(2):396–411.
Baumstark A, Jendrike N, Kamecke U, Liebing C, Pleus S, Freckmann G. Measurement accuracy of two professional‐use systems for point‐of‐care testing of blood glucose. Clin Chem Lab Med. 2020;58(3):445–455.
DuBois JA, Slingerland RJ, Fokkert M, Roman A, Tran NK, Clarke W, et al. Bedside glucose monitoring‐is it safe? A new, regulatory‐compliant risk assessment evaluation protocol in critically ill patient care settings. Crit Care Med. 2017;45(4):567–574.
Vučić Lovrenčić M, Radišić Biljak V, Božičević S, Pape‐Medvidović E, Ljubić S. Validation of point‐of‐care glucose testing for diagnosis of type 2 diabetes. Int J Endocrinol. 2013;2013:206309.
Corporation NB. The StatStrip® Glucose and ß‐Ketone Hospital Meter instructions for use manual. 2020.
El‐Osta A, Woringer M, Pizzo E, Verhoef T, Dickie C, Ni MZ, et al. Does use of point‐of‐care testing improve cost‐effectiveness of the NHS Health Check programme in the primary care setting? A cost‐minimisation analysis. BMJ Open. 2017;7(8):e015494.
Goldstein LN, Wells M, Vincent‐Lambert C. The cost‐effectiveness of upfront point‐of‐care testing in the emergency department: a secondary analysis of a randomised, controlled trial. Scand J Trauma Resusc Emerg Med. 2019;27(1):110.
Srimaekarat T. Capillary blood glucose screening (Accu‐Chek Advantage) for gestational diabetes. J Med Assoc Thai. 2009;92(10):1268–1272.
Stavrianos C, Anastasiou E. Oral glucose tolerance test evaluation with forearm and fingertip glucose measurements in pregnant women. Diabetes Care. 2004;27(2):627–628.
Boriboonhirunsarn D, Robkhonburi A, Asad‐dehghan M. Accuracy of capillary blood glucose for 50‐g glucose challenge test for gestational diabetes screening. Diabetol Int. 2022;13(3):561–565.
Bruns DE, Knowler WC. Stabilization of glucose in blood samples: why it matters. Clin Chem. 2009;55(5):850–852.
Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2011;57(6):e1–e47.
Daly N, Carroll C, Flynn I, Harley R, Maguire P, Turner M. Evaluation of point‐of‐care maternal glucose measurements for the diagnosis of gestational diabetes mellitus. BJOG. 2017;124(11):1746–1752.
van den Berg S, Thelen M, Boonen K. Inventarisation of the (pre) analytical aspects of the glucose determination in Dutch laboratories: time for harmonization. Ned Tijdschr Klin Chem Labgeneesk. 2015;40(1):69.
Lippi G, Montagnana M, Giavarina D. National survey on the pre‐analytical variability in a representative cohort of Italian laboratories. Clin Chem Lab Med. 2006;44(12):1491–1494.
Bhavadharini B, Mahalakshmi MM, Maheswari K, Kalaiyarasi G, Anjana RM, Deepa M, et al. Use of capillary blood glucose for screening for gestational diabetes mellitus in resource‐constrained settings. Acta Diabetol. 2016;53(1):91–97.
García‐Claver A, Ramos‐Corral R, Laviña‐Fañanás C, Solans‐Blecua I, Puzo‐Foncillas J. Capillary glucose concentration during oral glucose tolerance test for the diagnosis of gestational diabetes. Int J Gynecol Obstet. 2020;150(2):234–240.
Balaji V, Madhuri BS, Paneerselvam A, Arthi T, Seshiah V. Comparison of venous plasma glucose and capillary whole blood glucose in the diagnosis of gestational diabetes mellitus: a community‐based study. Diabetes Technol Ther. 2012;14(2):131–134.
Balaji V, Balaji MS, Paneerselvam A, Thiyagarajah A, Seshiah V. Point of care for gestational diabetes mellitus—a community‐based study. J Indian Med Assoc. 2012;110(5):314–316.
Hossain N, Shah T, Rajar S, Sehtoo A, Riaz M, Fawwad A, et al. Comparison of venous plasma glucose and capillary whole blood glucose in diagnosis of gestational diabetes: study from Karachi, Pakistan. Clin Epidemiol Glob Health. 2017;5(4):185–189.
Afzal N, Kanwal M, Irfani I, Mahmood A, Shams N, Fehmida. Accuracy of fasting capillary blood glucose by glucometer for screening of gestational diabetes mellitus: simplicity is the key. J Soc Obstet Gynaecol Pakistan. 2021;11:82–86.
Jadhav DS, Wankhede UN. Comparative study of capillary blood glucose estimation by glucometer and venous plasma glucose estimation in women undergoing the one step DIPSI test (diabetes in pregnancy study group India) for screening and diagnosis of gestational diabetes mellitus. International Journal of reproduction, contraception. Obstet Gynecol. 2017;6(4):1488.
O'Malley EG, Reynolds CME, O'Kelly R, Killalea A, Sheehan SR, Turner MJ. A prospective evaluation of point‐of‐care measurements of maternal glucose for the diagnosis of gestational diabetes mellitus. Clin Chem. 2020;66(2):316–323.
Adam S, Rheeder P. Evaluating the utility of a point‐of‐care glucometer for the diagnosis of gestational diabetes. Int J Gynaecol Obstet. 2018;141(1):91–96.
van den Berg SA, de Groot MJ, Salden LP, Draad PJ, Dijkstra IM, Lunshof S, et al. Pregnancy diabetes: a comparison of diagnostic protocols based on point‐of‐care, routine and optimized laboratory conditions. Sci Rep. 2015;5:16302.
Gallardo H, Lomelin‐Gascon J, Martinez LA, Montoya A, Reyes‐Muñoz E, Tapia‐Conyer RC. 1358‐P: point of care OGTT for the screening of gestational diabetes: a feasible proposal for low‐resource settings. Diabetes. 2020;69(Supplement_1):1358.
Kristensen K, Wangel A‐M, Katsarou A, Shaat N, Simmons D, Fadl H, et al. Diagnosis of gestational diabetes mellitus with point‐of‐care methods for glucose versus hospital laboratory method using isotope dilution gas chromatography‐mass spectrometry as reference. J Diabetes Res. 2020;2020:7937403.
Landberg E, Nevander S, Hadi M, Blomberg M, Norling A, Ekman B, et al. Evaluation of venous plasma glucose measured by point‐of‐care testing (Accu‐Chek Inform II) and a hospital laboratory hexokinase method (Cobas c701) in oral glucose tolerance testing during pregnancy – a challenge in diagnostic accuracy. Scand J Clin Lab Invest. 2021;81(8):607–614.
Nevander S, Landberg E, Blomberg M, Ekman B, Lilliecreutz C. Comparison of venous and capillary sampling in Oral glucose testing for the diagnosis of gestational diabetes mellitus: a diagnostic accuracy cross‐sectional study using Accu‐Chek Inform II. Diagnostics. 2020;10(12):1011.
Mohsen E, Abu‐Elkheir M, Elghaffar A, Dawood S, Mohey S, Hazzaa E, et al. The accuracy of capillary whole blood glucose versus venous plasma glucose in the diagnosis of gestational diabetes mellitus in Egyptian women. J Womens Health Reprod Med. 2020;4(3):4.
فهرسة مساهمة: Keywords: capillary blood glucose; gestational diabetes mellitus; oral glucose tolerance test; point of care; venous plasma glucose
المشرفين على المادة: 0 (Blood Glucose)
تواريخ الأحداث: Date Created: 20240318 Date Completed: 20240703 Latest Revision: 20240703
رمز التحديث: 20240703
DOI: 10.1111/1471-0528.17811
PMID: 38497098
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-0528
DOI:10.1111/1471-0528.17811