Dataset from Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part
of the body which helps fight infections) mistakenly attacks and destroys the cells that
produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's
ability to produce insulin decreases. There is evidence suggesting that repeated oral
administration of an autoantigen (the same protein that the immune system is reacting to) may
introduce a protective immunity and cause the immune system to stop its attack. An earlier,
large scale study was done to see if oral insulin could delay or prevent the development of
Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results
showed that for the entire study population, oral insulin did not delay or prevent Type 1
diabetes. However, an analysis that was done after the conclusion of the trial suggested a
potential beneficial effect in a subgroup of participants. The participants who seemed to
benefit from oral insulin had higher levels of insulin autoantibodies which are directed
against insulin itself ( called mIAA).

The Type 1 Diabetes TrialNet study group will further explore the potential role of oral
insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also
include a secondary group of individuals at different levels of risk than those in the
primary cohort to gather information for future studies.

1型糖尿病（Type 1 diabetes, T1D）是一种自身免疫性疾病，即机体免疫系统——负责抵御感染的身体组分——错误地攻击并破坏产生胰岛素的细胞（胰腺内的胰岛细胞）。随着这些细胞被破坏，机体产生胰岛素的能力逐渐下降。有证据表明，重复口服给予自身抗原（即免疫系统靶向的同种蛋白质）可诱导保护性免疫，使免疫系统停止攻击。此前一项大规模研究旨在探究口服胰岛素能否延缓或预防1型糖尿病高危亲属的发病。整体研究结果显示，在全部研究人群中，口服胰岛素并未起到延缓或预防1型糖尿病的作用。然而，试验结束后开展的一项分析提示，在某一亚组受试者中或许存在潜在获益。这些似乎从口服胰岛素中获益的受试者，其体内针对胰岛素本身的胰岛素自身抗体（mIAA）水平更高。

1型糖尿病试验网（Type 1 Diabetes TrialNet）研究组将在同类高危人群中进一步探究口服胰岛素延缓或预防1型糖尿病的潜在作用。本研究还将纳入一组与原始队列风险等级不同的次要队列人群，为后续研究收集相关数据。