Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes: TEDDY

Kendra Vehik, Steven W. Fiske, Chad A. Logan, Daniel Agardh, Corrado M. Cilio, William Hagopian, Olli Simell, Merja Roivainen, Jin-Xiong She, Thomas Briese, Sami Oikarinen, Heikki Hyoty, Anette G. Ziegler, Marian Rewers, Ake Lernmark, Beena Akolkar, Jeffrey P. Krischer, Brant R. Burkhardt

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Background: The vast array and quantity of longitudinal samples collected in The Environmental Determinants of Diabetes in the Young study present a series of challenges in terms of quality control procedures and data validity. To address this, pilot studies have been conducted to standardize and enhance both biospecimen collection and sample obtainment in terms of autoantibody collection, stool sample preservation, RNA, biomarker stability, metabolic biomarkers and T-cell viability. Research Design and Methods: The Environmental Determinants of Diabetes in the Young is a multicentre, international prospective study (n=8677) designed to identify environmental triggers of type 1 diabetes (T1D) in genetically at-risk children from ages 3months until 15years. The study is conducted through six primary clinical centres located in four countries. Results: As of May 2012, over three million biological samples and 250 million total data points have been collected, which will be analysed to assess autoimmunity status, presence of inflammatory biomarkers, genetic factors, exposure to infectious agents, dietary biomarkers and other potentially important environmental exposures in relation to autoimmunity and progression to T1D. Conclusions: Detailed procedures were utilized to standardize both data harmonization and management when handling a large quantity of longitudinal samples obtained from multiple locations. In addition, a description of the available specimens is provided that serve as an invaluable repository for the elucidation of determinants in T1D focusing on autoantibody concordance and harmonization, transglutaminase autoantibody, inflammatory biomarkers (T-cells), genetic proficiency testing, RNA lab internal quality control testing, infectious agents (monitoring cross-contamination, virus preservation and nasal swab collection validity) and HbA1c testing.

Original languageEnglish (US)
Pages (from-to)557-567
Number of pages11
JournalDiabetes/Metabolism Research and Reviews
Volume29
Issue number7
DOIs
StatePublished - Oct 1 2013

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Type 1 Diabetes Mellitus
Quality Control
Biomarkers
Autoantibodies
Autoimmunity
T-Lymphocytes
Transglutaminases
Environmental Exposure
RNA Stability
Genetic Testing
Nose
Cell Survival
Research Design
Prospective Studies
RNA
Viruses

Keywords

  • Biomarker stability
  • Data integrity
  • Metabolic biomarkers
  • Quality control
  • RNA
  • Stool sample preservation
  • T-cell viability

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes : TEDDY. / Vehik, Kendra; Fiske, Steven W.; Logan, Chad A.; Agardh, Daniel; Cilio, Corrado M.; Hagopian, William; Simell, Olli; Roivainen, Merja; She, Jin-Xiong; Briese, Thomas; Oikarinen, Sami; Hyoty, Heikki; Ziegler, Anette G.; Rewers, Marian; Lernmark, Ake; Akolkar, Beena; Krischer, Jeffrey P.; Burkhardt, Brant R.

In: Diabetes/Metabolism Research and Reviews, Vol. 29, No. 7, 01.10.2013, p. 557-567.

Research output: Contribution to journalArticle

Vehik, K, Fiske, SW, Logan, CA, Agardh, D, Cilio, CM, Hagopian, W, Simell, O, Roivainen, M, She, J-X, Briese, T, Oikarinen, S, Hyoty, H, Ziegler, AG, Rewers, M, Lernmark, A, Akolkar, B, Krischer, JP & Burkhardt, BR 2013, 'Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes: TEDDY', Diabetes/Metabolism Research and Reviews, vol. 29, no. 7, pp. 557-567. https://doi.org/10.1002/dmrr.2427
Vehik, Kendra ; Fiske, Steven W. ; Logan, Chad A. ; Agardh, Daniel ; Cilio, Corrado M. ; Hagopian, William ; Simell, Olli ; Roivainen, Merja ; She, Jin-Xiong ; Briese, Thomas ; Oikarinen, Sami ; Hyoty, Heikki ; Ziegler, Anette G. ; Rewers, Marian ; Lernmark, Ake ; Akolkar, Beena ; Krischer, Jeffrey P. ; Burkhardt, Brant R. / Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes : TEDDY. In: Diabetes/Metabolism Research and Reviews. 2013 ; Vol. 29, No. 7. pp. 557-567.
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AU - Vehik, Kendra

AU - Fiske, Steven W.

AU - Logan, Chad A.

AU - Agardh, Daniel

AU - Cilio, Corrado M.

AU - Hagopian, William

AU - Simell, Olli

AU - Roivainen, Merja

AU - She, Jin-Xiong

AU - Briese, Thomas

AU - Oikarinen, Sami

AU - Hyoty, Heikki

AU - Ziegler, Anette G.

AU - Rewers, Marian

AU - Lernmark, Ake

AU - Akolkar, Beena

AU - Krischer, Jeffrey P.

AU - Burkhardt, Brant R.

PY - 2013/10/1

Y1 - 2013/10/1

N2 - Background: The vast array and quantity of longitudinal samples collected in The Environmental Determinants of Diabetes in the Young study present a series of challenges in terms of quality control procedures and data validity. To address this, pilot studies have been conducted to standardize and enhance both biospecimen collection and sample obtainment in terms of autoantibody collection, stool sample preservation, RNA, biomarker stability, metabolic biomarkers and T-cell viability. Research Design and Methods: The Environmental Determinants of Diabetes in the Young is a multicentre, international prospective study (n=8677) designed to identify environmental triggers of type 1 diabetes (T1D) in genetically at-risk children from ages 3months until 15years. The study is conducted through six primary clinical centres located in four countries. Results: As of May 2012, over three million biological samples and 250 million total data points have been collected, which will be analysed to assess autoimmunity status, presence of inflammatory biomarkers, genetic factors, exposure to infectious agents, dietary biomarkers and other potentially important environmental exposures in relation to autoimmunity and progression to T1D. Conclusions: Detailed procedures were utilized to standardize both data harmonization and management when handling a large quantity of longitudinal samples obtained from multiple locations. In addition, a description of the available specimens is provided that serve as an invaluable repository for the elucidation of determinants in T1D focusing on autoantibody concordance and harmonization, transglutaminase autoantibody, inflammatory biomarkers (T-cells), genetic proficiency testing, RNA lab internal quality control testing, infectious agents (monitoring cross-contamination, virus preservation and nasal swab collection validity) and HbA1c testing.

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