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Diabetes Metab Res Rev. 2016 Nov;32(8):827-834. doi: 10.1002/dmrr.2800. Epub 2016 Apr 21.

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

Author information

1
Health Informatics Institute, University of South Florida, Tampa, FL, USA.
2
Health Informatics Institute, University of South Florida, Tampa, FL, USA. jpkrischer@epi.usf.edu.

Abstract

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.

KEYWORDS:

C-peptide; clinical trial; type 1 diabetes

PMID:
26991448
PMCID:
PMC5117187
DOI:
10.1002/dmrr.2800
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

The authors declare that they have no conflicts of interest. Drs. Bundy and Krischer work at the TrialNet Coordinating Center funded by the NIDDK of the NIH.

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