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|Title:||Beta cell function in type 1 diabetes determined from clinical and fasting biochemical variables|
|Citation:||Diabetologia, 2019; 62(1):33-40|
|John M. Wentworth, Naiara G. Bediaga, Lynne C. Giles, Mario Ehlers, Stephen E. Gitelman, Susan Geyer, Carmella Evans-Molina, Leonard C. Harrison, the Type 1 Diabetes TrialNet Study Group, the Immune Tolerance Network Study Group|
|Abstract:||AIMS/HYPOTHESIS:Beta cell function in type 1 diabetes is commonly assessed as the average plasma C-peptide concentration over 2 h following a mixed-meal test (CPAVE). Monitoring of disease progression and response to disease-modifying therapy would benefit from a simpler, more convenient and less costly measure. Therefore, we determined whether CPAVE could be reliably estimated from routine clinical variables. METHODS:Clinical and fasting biochemical data from eight randomised therapy trials involving participants with recently diagnosed type 1 diabetes were used to develop and validate linear models to estimate CPAVE and to test their accuracy in estimating loss of beta cell function and response to immune therapy. RESULTS:A model based on disease duration, BMI, insulin dose, HbA1c, fasting plasma C-peptide and fasting plasma glucose most accurately estimated loss of beta cell function (area under the receiver operating characteristic curve [AUROC] 0.89 [95% CI 0.87, 0.92]) and was superior to the commonly used insulin-dose-adjusted HbA1c (IDAA1c) measure (AUROC 0.72 [95% CI 0.68, 0.76]). Model-estimated CPAVE (CPEST) reliably identified treatment effects in randomised trials. CPEST, compared with CPAVE, required only a modest (up to 17%) increase in sample size for equivalent statistical power. CONCLUSIONS/INTERPRETATION:CPEST, approximated from six variables at a single time point, accurately identifies loss of beta cell function in type 1 diabetes and is comparable to CPAVE for identifying treatment effects. CPEST could serve as a convenient and economical measure of beta cell function in the clinic and as a primary outcome measure in trials of disease-modifying therapy in type 1 diabetes.|
|Keywords:||Type 1 Diabetes TrialNet Study Group|
Immune Tolerance Network Study Group
|Rights:||© Springer-Verlag GmbH Germany, part of Springer Nature 2018|
|Appears in Collections:||Aurora harvest 8|
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