Fr1da Insulin Intervention - Mechanistic study using oral insulin for immune and treatment efficacy in secondary prevention of type 1 diabetes - Fr1da Insulin Intervention

Technische Universität München, Fakultät für Medizin0 个研究点目标入组 220 人开始时间: 2015年8月11日最近更新: 2021年8月10日

试验速览

暂无简介。

•1.Written informed consent signed by either parent(s) or legal guardian(s).
•2.Children aged 2 years to 12 years.
•3.Positive for at least two islet autoantibodies out of autoantibodies to glutamic acid decarboxylase (GAD65), to insulin (IAA), autoantibodies to IA-2 (IA2A), or autoantibodies to zink transporter 8 (ZnT8A) (time between screening sample collection and randomization must not exceed 90 days).
•4.Normoglycemia assessed by oral glucose tolerance test (OGTT).
•5. Participation in an observational study that regularly monitors diabetes development
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 220
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Dysglycaemia or overt hyperglycemia (diabetes)
•2.Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators.
•3.Current participation in another intervention trial.
•4.Any condition that could be associated with poor compliance.

发起方

Technische Universität München, Fakultät für Medizin