More than a decade ago, the IDS published a paper regarding Guidelines for New Onset clinical trials in type 1 diabetes. We now have considerable data from clinical trials; leading us to consider whether it is time to recommend changes to our "standard" template.
In this round table discussion, we will address entry critiera - age of subjects, time from diagnosis, outcome measures - what do we need in addition to C-peptide?, and study design issues - will mechanistic based studies be helpful?