Insulin is necessary but not sufficient: changing the therapeutic paradigm in type 1 diabetes.

Despite the clear evidence that type 1 diabetes (T1D) begins well before hyperglycemia is evident, there are no clinically available disease-modifying therapies for early-stage disease. However, following the exciting results of the Teplizumab Prevention Study, the first study to demonstrate that overt T1D can be delayed with immunotherapy, there is renewed optimism that in the future, T1D will be treated before hyperglycemia develops. A different treatment paradigm is needed, as a majority of people with T1D do not meet the glycemic targets that are associated with a lower risk of T1D complications and therefore remain vulnerable to complications and shortened life expectancy. The following review will outline the history and current status of immunotherapy for T1D and highlight some challenges and ideas for the future. Although such efforts have been worldwide, we will focus particularly on the activities of Diabetes TrialNet, a National Institutes of Health consortium launched in 2004.