The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.
Implementing a Reference Measurement System for C-Peptide: Successes and Lessons Learned
Open accessAbstract
BACKGROUND: Assessment of endogenous insulin secretion by measuring C-peptide concentrations is widely accepted. Recent studies have shown that preservation of even small amounts of endogenous C-peptide production in patients with type 1 diabetes reduces risks for diabetic complications. Harmonization of C-peptide results will facilitate comparison of data from different research studies and later among clinical laboratory results at different sites using different assay methods. CONTENT: This review provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a reference measurement system for C-peptide. SUMMARY: Efforts to harmonize C-peptide results are described, including those by the National Institute of Diabetes and Digestive and Kidney Diseases–led C-peptide Standardization Committee in the US, activities in Japan, efforts by the National Institute for Biological Standards and Control in the UK, as well as activities led by the Bureau International des Poids et Mesures and the National Metrology Institute in China. A traceability scheme is proposed along with the next steps for implementation. Suggestions are made for better collaboration to optimize the harmonization process for other measurands.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source says what the claim attributes to it.
In the citing paper
“Stakeholders in the U.S., Japan, and elsewhere have worked on developing a reference standard and traceability schemes, but there is a need for further coordination to assure worldwide harmonization of C-peptide (516).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [516]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Palmer, J. P., Fleming, G. A., Greenbaum, C. J., Herold, K. C., Jansa, L. D., Kolb, H., Lachin, J. M., Polonsky, K. S., Pozzilli, P., Skyler, J. S., et al. (2004) · Diabetes · doi:10.2337/diabetes.53.1.250 · Cited by 491
Moran, A., Bundy, B. N., BECKER, D. J., DiMeglio, L. A., Gitelman, S. E., Goland, R., Greenbaum, C. J., Herold, K. C., Marks, J. B., Raskin, P., et al. (2013) · The Lancet · doi:10.1016/s0140-6736(13)60023-9 · Cited by 364
Greenbaum, C. J., Mandrup-Poulsen, T. R., McGee, P. F., Battelino, T., Haastert, B., Ludvigsson, J., Pozzilli, P., Lachin, J. M., & Kolb, H. (2008) · Diabetes Care · doi:10.2337/dc07-2451 · Cited by 285
Lachin, J. M., McGee, P., Palmer, J. P., & for the DCCT/EDIC Research Group (2014) · Diabetes · doi:10.2337/db13-0881 · Cited by 283
Teplizumab Preserves C-Peptide in Recent-Onset Type 1 Diabetes
Hagopian, W., Ferry, R. J., Sherry, N., Carlin, D., Bonvini, E., Johnson, S., Stein, K. E., Koenig, S., Daifotis, A. G., Herold, K. C., et al. (2013) · Diabetes · doi:10.2337/db13-0236 · Cited by 247
Traceability in Laboratory Medicine
Vesper, H. W., & Thienpont, L. M. (2009) · Clinical Chemistry · doi:10.1373/clinchem.2008.107052 · Cited by 169
C-Peptide Replacement Therapy and Sensory Nerve Function in Type 1 Diabetic Neuropathy
Ekberg, K., Brismar, T., Johansson, B., Lindström, P., Juntti‐Berggren, L., Norrby, A., Berne, C., Arnqvist, H. J., Bolinder, J., & Wahren, J. (2006) · Diabetes Care · doi:10.2337/dc06-1274 · Cited by 164
Standardization of C-peptide measurements
Little, R. R., Rohlfing, C. L., Tennill, A. L., Madsen, R. W., Polonsky, K. S., Myers, G. L., Greenbaum, C. J., Palmer, J. P., Rogatsky, E., & Stein, D. T. (2008) · Clinical Chemistry · doi:10.1373/clinchem.2007.101287 · Cited by 103
Self-citationBraga, F., & Panteghini, M. (2013) · Clinica Chimica Acta · doi:10.1016/j.cca.2013.11.022 · Cited by 86
Harmonization: the Sample, the Measurement, and the Report
Miller, W. G., Tate, J. R., Barth, J. H., & Jones, G. R. D. (2014) · Annals of Laboratory Medicine · doi:10.3343/alm.2014.34.3.187 · Cited by 82
Kato, M., Kato, H., Eyama, S., & Takatsu, A. (2009) · Journal of Chromatography B · doi:10.1016/j.jchromb.2009.07.027 · Cited by 73
Self-citationKinumi, T., Goto, M., Eyama, S., Kato, M., Kasama, T., & Takatsu, A. (2012) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-012-6097-1 · Cited by 53
Self-citationThe Joint Committee for Traceability in Laboratory Medicine (JCTLM) – its history and operation
Jones, G. R. D., & Jackson, C. M. (2015) · Clinica Chimica Acta · doi:10.1016/j.cca.2015.11.016 · Cited by 50
Rogatsky, E., Balent, B., Goswami, G., Tomuta, V., Jayatillake, H., Cruikshank, G., Vele, L., & Stein, D. T. (2006) · Clinical Chemistry · doi:10.1373/clinchem.2005.063081 · Cited by 47
Self-citationMarx, N., Silbernagel, G., Brandenburg, V. M., Burgmaier, M., Kleber, M. E., Grammer, T. B., Winkelmann, B. R., Boehm, B. O., & März, W. (2012) · Diabetes Care · doi:10.2337/dc12-1211 · Cited by 43
International Comparison of C-Peptide Measurements
Wiedmeyer, H.-M., Polonsky, K. S., Myers, G. L., Little, R. R., Greenbaum, C. J., Goldstein, D. E., & Palmer, J. P. (2007) · Clinical Chemistry · doi:10.1373/clinchem.2006.081570 · Cited by 42
Self-citationGreenberg, N. L. (2014) · Clinica Chimica Acta · doi:10.1016/j.cca.2013.12.045 · Cited by 36
Luppi, P., Kallas, Å., & Wahren, J. (2013) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.2409 · Cited by 29
C-Peptide Measurement and its Clinical Usefulness: A Review
Bonser, A. M., & Garcia‐Webb, P. (1981) · Annals of Clinical Biochemistry International Journal of Laboratory Medicine · doi:10.1177/000456328101800402 · Cited by 28
Kinumi, T., Mizuno, R., & Takatsu, A. (2014) · Journal of Chromatography B · doi:10.1016/j.jchromb.2014.02.019 · Cited by 25
Self-citationHuman C-peptide Quantitation by LC-MS Isotope-Dilution Assay in Serum or Urine Samples
Stoyanov, A. V. (2013) · Journal of Chromatography & Separation Techniques · doi:10.4172/2157-7064.1000172 · Cited by 23
Kinumi, T., Ichikawa, R., Arimoto, H., & Takatsu, A. (2010) · Analytical Sciences · doi:10.2116/analsci.26.1007 · Cited by 21
Self-citationKato, M., Yamazaki, T., Kato, H., Eyama, S., Goto, M., Yoshioka, M., & Takatsu, A. (2015) · Analytical Sciences · doi:10.2116/analsci.31.805 · Cited by 14
Self-citation
Flagged first, then by citations
Research works printed but not linked: 2
- Josephs, 2017, Metrologia, 54
- Research report, Program for development of measurement standard and intellectual infrastructure
Cited by
Sorted by citations
Clinical and Laboratory Standards Institute
Gressner, A. M., & Arndt, T. (2019) · Springer Reference Medizin · doi:10.1007/978-3-662-48986-4_300416 · Cited by 5,092
Gressner, A. M., & Arndt, T. (2019) · Springer Reference Medizin · doi:10.1007/978-3-662-48986-4_310898 · Cited by 473
CAH (Congenital Adrenal Hyperplasia)-Screening
Gressner, A. M., & Arndt, T. (2019) · Springer Reference Medizin · doi:10.1007/978-3-662-48986-4_300351 · Cited by 368
Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Lernmark, Å., Metzger, B. E., Nathan, D. M., & Kirkman, M. S. (2023) · Diabetes Care · doi:10.2337/dci23-0036 · Cited by 351
Complement-associated protein SP-40,40
Gressner, A. M., & Arndt, T. (2019) · Springer Reference Medizin · doi:10.1007/978-3-662-48986-4_300426 · Cited by 297
Metadata
- Authors
- Little, R. R., Wielgosz, R. I., Josephs, R., Kinumi, T., Takatsu, A., Li, H., Stein, D., & Burns, C.
- Affiliations
- University of Missouri (US)
- Bureau international des poids et mesures (FR)
- National Metrology Institute of Japan (JP)
- National Institute of Metrology (CN)
- Albert Einstein College of Medicine (US)
- National Institute for Biological Standards and Control (GB)
- Corresponding author
- Little, Randie R
- ORCID
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-09-01
- Volume
- 63
- Issue
- 9
- Pages
- 1447-1456
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- PMC
- PMC5575958
- OpenAlex
- W2696753613
- Semantic Scholar
- 909dfba036768bf9c9b2a61af2b3182361e08901
- Cited by
- 383
- References
- 23
- Citations by year
- 2026: 9 · 2025: 6 · 2024: 5 · 2023: 6 · 2022: 6 · 2021: 3 · 2020: 3 · 2019: 336 · 2018: 7 · 2017: 2
- FWCI
- 11.68
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK096587–01)
- National Institute of Mental Health (2014DFA31810, K115/P55.2)
- Topics
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Physical Sciences › Physics and Astronomy › Instrumentation › Scientific Measurement and Uncertainty Evaluation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- C-peptide, reference measurement system, assay harmonization, standardization, traceability, type 1 diabetes, endogenous insulin secretion, metrology, international cooperation
- MeSH terms
- C-Peptide, Diabetes Mellitus, Type 1, Humans, Reference Standards, Observer Variation, Clinical Laboratory Services
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
