Validation in the general population of a C-peptide estimate equation to measure beta cell function in recent-onset type
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SHORT COMMUNICATION
Validation in the general population of a C‑peptide estimate equation to measure beta cell function in recent‑onset type 1 diabetes Joanne Wang1 · Naiara Bediaga2,3 · Roberto Mallone4,5 · Etienne Larger4,5 · Leonard C. Harrison2,3 · John M. Wentworth1,2,3 · the ImMaDiab Study Group Received: 5 July 2020 / Accepted: 3 September 2020 © Springer-Verlag Italia S.r.l., part of Springer Nature 2020
Beta cell function, measured as the average C-peptide response to a mixed meal (CPAVE), is commonly used to assess the effectiveness of immune therapy in recent-onset type 1 diabetes. However, the mixed meal test is not suited for routine use because it requires blood sampling at six time points over two hours. We recently developed an equation to estimate average C-peptide, called C PEST, based on insulin dose, disease duration, body mass index, HbA1c, fasting glucose and fasting C-peptide [1] and confirmed that it identified treatment effects in an independent clinical trial population [2]. To further explore the accuracy and clinical utility of CPEST, we compared it to CPAVE obtained from a population of children and adults with recent-onset type 1 diabetes who participated in the ImMaDiab study of immune and beta cell function ([3]; NCT01747967). Ethical approval was granted by the Comité de Protection des Personnes Ile de France 1–2 and all participants
Managed by Massimo Federici. ImMaDiab Investigators and their affiliations are listed in the Appendix. * John M. Wentworth [email protected] 1
Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville 3050, Australia
2
Walter and Eliza Hall Institute Department of Population Health and Immunity, 1G Royal Parade, Parkville 3052, Australia
3
Department of Medical Biology, University of Melbourne, Parkville 3052, Australia
4
Université de Paris, Institut Cochin, CNRS, INSERM, 75014 Paris, France
5
Service de Diabétologie Et Immunologie Clinique, Assistance Publique Hôpitaux de Paris, Hôpitaux Universitaires de Paris Centre-Université de Paris, Cochin Hospital, 75014 Paris, France
or their legal guardians provided written informed consent. Inclusion criteria were: diagnosis of type 1 diabetes within 10 weeks of the first meal test; age between 6 and 60 years; the presence of at least one autoantibody against glutamic acid decarboxylase (GAD), insulinoma-associated antigen (IA-2), zinc transporter 8 (ZnT8) or insulin. Exclusion criteria included current use of immunosuppressive medication, thyroid disease treated with methimazole, primary immune deficiency, progressive cancer and chronic viral infection. Meal tests to measure C PAVE were performed up to six times every six months during the first three years after diagnosis. HbA1c and C-peptide were measured using Variant II HPLC (Bio-Rad Laboratories, Perth, UK) and Centaur RIA (Siemens, Erlangen, Germany) assays, respectively. Statistical analyses were performed using Prism software (v8.3.1 for Mac; GraphPad, San Diego, CA, USA). Values at 3, 6, 12, 18 a
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