Effect of oral insulin on prevention of diabetes in relatives of patients with T1DM: a randomized clinical trial

Abstract

Insulin is one of the autoantigens involved in the pathogenesis of T1DM. Therefore several trials with insulin given orally, nasal or subcutaneous have been conducted to prevent the development of T1DM in genetically high risk populations. This trial design built on the results of DPT-1 and included further investigations related to first phase insulin release. A dose of 7.5 mg/d did not prevent T1DM in the high risk population of autoantibody positive T1DM relatives. Possibly ongoing trials with higher insulin doses might show better effects on beta cell autoimmunity and T1DM incidence. Knowledge of pre-diabetes staging has informed several prevention trials and epidemiological studies in high risk populations. Individuals with two or more beta cell antibodies are now classified as Stage 1. Without intervention, most of these will develop abnormal glucose tolerance (Stage 2) and then clinically manifest T1DM (Stage 3). The overall rate of progression from Stage 1 to 3 is ~9.5% per year.