Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies

<h4>Background</h4> We compared HbA1c values obtained from capillary blood collection kits versus venous whole blood collections in study participants with type 1 or type 2 diabetes. <h4>Methods</h4> A total of 122 subjects, 64 with type 2 diabetes participating in the Glycem...

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Autores principales:	David M. Nathan, Heidi Krause-Steinrauf, Barbara H. Braffett, Valerie L. Arends, Naji Younes, Paula McGee, Claire Lund, Mary Johnson, Gayle Lorenzi, Xiaoyu Gao, Michael W. Steffes, John M. Lachin, the GRADE Research Group, the DCCT/EDIC Research Group
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/a1509ef7c5804f69b3b15ceb3c2de327
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spelling	oai:doaj.org-article:a1509ef7c5804f69b3b15ceb3c2de3272021-11-25T06:10:58ZComparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies1932-6203https://doaj.org/article/a1509ef7c5804f69b3b15ceb3c2de3272021-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592405/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4> We compared HbA1c values obtained from capillary blood collection kits versus venous whole blood collections in study participants with type 1 or type 2 diabetes. <h4>Methods</h4> A total of 122 subjects, 64 with type 2 diabetes participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study and 58 with type 1 diabetes from the Epidemiology of Diabetes Interventions and Complications (EDIC) Study, participated in the validation study. Capillary tubes were filled by fingerstick by the participants on the same day as the collection of venous whole blood samples in EDTA-containing test tubes and were mailed to the central laboratory. HbA1c in all samples was measured with the same high-performance liquid chromatography. GRADE participants also completed a questionnaire on the ease of performing capillary collections. <h4>Results</h4> Participants from 22 clinical centers (GRADE n = 5, EDIC n = 17) were between 35 and 86 years of age, with 52% male and diverse race/ethnicities. Venous HbA1c results ranged between 5.4–11.9% (35.5–106.6 mmol/mol) with corresponding capillary results ranging between 4.2–11.9% (22.4–106.6 mmol/mol). The venous and capillary results were highly correlated (R2 = 0.993) and 96.7% differed by ≤0.2% (2.2 mmol/mol). Of participants surveyed, 69% indicated that the instructions and collection were easy to follow and 97% felt the collection method would be easy to do at home. <h4>Conclusions</h4> The capillary blood HbA1c results compared well with the conventional venous whole blood results. The capillary kits can be employed in other studies to reduce interruption of critical data collection and potentially to augment clinical care when in-person visits are not possible.David M. NathanHeidi Krause-SteinraufBarbara H. BraffettValerie L. ArendsNaji YounesPaula McGeeClaire LundMary JohnsonGayle LorenziXiaoyu GaoMichael W. SteffesJohn M. Lachinthe GRADE Research Groupthe DCCT/EDIC Research GroupPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q David M. Nathan Heidi Krause-Steinrauf Barbara H. Braffett Valerie L. Arends Naji Younes Paula McGee Claire Lund Mary Johnson Gayle Lorenzi Xiaoyu Gao Michael W. Steffes John M. Lachin the GRADE Research Group the DCCT/EDIC Research Group Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies
description	<h4>Background</h4> We compared HbA1c values obtained from capillary blood collection kits versus venous whole blood collections in study participants with type 1 or type 2 diabetes. <h4>Methods</h4> A total of 122 subjects, 64 with type 2 diabetes participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study and 58 with type 1 diabetes from the Epidemiology of Diabetes Interventions and Complications (EDIC) Study, participated in the validation study. Capillary tubes were filled by fingerstick by the participants on the same day as the collection of venous whole blood samples in EDTA-containing test tubes and were mailed to the central laboratory. HbA1c in all samples was measured with the same high-performance liquid chromatography. GRADE participants also completed a questionnaire on the ease of performing capillary collections. <h4>Results</h4> Participants from 22 clinical centers (GRADE n = 5, EDIC n = 17) were between 35 and 86 years of age, with 52% male and diverse race/ethnicities. Venous HbA1c results ranged between 5.4–11.9% (35.5–106.6 mmol/mol) with corresponding capillary results ranging between 4.2–11.9% (22.4–106.6 mmol/mol). The venous and capillary results were highly correlated (R2 = 0.993) and 96.7% differed by ≤0.2% (2.2 mmol/mol). Of participants surveyed, 69% indicated that the instructions and collection were easy to follow and 97% felt the collection method would be easy to do at home. <h4>Conclusions</h4> The capillary blood HbA1c results compared well with the conventional venous whole blood results. The capillary kits can be employed in other studies to reduce interruption of critical data collection and potentially to augment clinical care when in-person visits are not possible.
format	article
author	David M. Nathan Heidi Krause-Steinrauf Barbara H. Braffett Valerie L. Arends Naji Younes Paula McGee Claire Lund Mary Johnson Gayle Lorenzi Xiaoyu Gao Michael W. Steffes John M. Lachin the GRADE Research Group the DCCT/EDIC Research Group
author_facet	David M. Nathan Heidi Krause-Steinrauf Barbara H. Braffett Valerie L. Arends Naji Younes Paula McGee Claire Lund Mary Johnson Gayle Lorenzi Xiaoyu Gao Michael W. Steffes John M. Lachin the GRADE Research Group the DCCT/EDIC Research Group
author_sort	David M. Nathan
title	Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies
title_short	Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies
title_full	Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies
title_fullStr	Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies
title_full_unstemmed	Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies
title_sort	comparison of central laboratory hba1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the grade and edic studies
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/a1509ef7c5804f69b3b15ceb3c2de327
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Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies

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