A model-based approach to sample size estimation in recent onset type 1 diabetes.

Diabetes Metab Res Rev 2016 11 21;32(8):827-834. Epub 2016 Apr 21.

Health Informatics Institute, University of South Florida, Tampa, FL, USA.

Background: The area under the curve C-peptide following a 2-h mixed meal tolerance test from 498 individuals enrolled on five prior TrialNet studies of recent onset type 1 diabetes from baseline to 12 months after enrolment were modelled to produce estimates of its rate of loss and variance.

Results: Age at diagnosis and baseline C-peptide were found to be significant predictors, and adjusting for these in an ANCOVA resulted in estimates with lower variance.

Conclusions: Using these results as planning parameters for new studies results in a nearly 50% reduction in the target sample size. The modelling also produces an expected C-peptide that can be used in observed versus expected calculations to estimate the presumption of benefit in ongoing trials. Copyright © 2016 John Wiley & Sons, Ltd.

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http://dx.doi.org/10.1002/dmrr.2800DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5117187PMC
November 2016
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References

(Supplied by CrossRef)

Snedecor et al.
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