Comparison of Visual Methods to Reanalyze Provocative Test Data from Randomized Controlled Clinical Trials in New- or Recent-Onset Type 1 Diabetes.

Introduction: Over the last 13 years, the Immune Tolerance Network (ITN), has conducted trials of agents to abrogate the autoimmunity underlying type 1 diabetes. Primary endpoints center on the change of C-peptide production during mixed meal tolerance tests (MMTT), measured as the area under the curve (AUC) or AUC mean over 2-3 years. Studies permit rapid-acting insulin until a few hours before the MMTT, and thus do not exclude overnight hyperglycemia prior to testing.