Study Center for Childhood Diabetes - Studies for Prevention and Immunotherapy of Type 1 Diabetes
Our clinical research is dedicated to conducting studies to prevent the development of the autoimmune disease type 1 diabetes in children, as well as to prevent the progression from an autoimmune to the metabolic disease type 1 diabetes, and to maintain the body's own insulin production.
Our clinical research is dedicated to conducting studies to prevent the development of the autoimmune disease type 1 diabetes in children, as well as to prevent the progression from an autoimmune to the metabolic disease type 1 diabetes, and to maintain the body's own insulin production.
Our clinical trials focus on novel treatment approaches to preserve the function of insulin-producing beta cells.
Treatments can be given at any stage of the pathogenesis of type 1 diabetes. In primary prevention studies, we are testing new treatments that can prevent or delay the onset of islet autoimmunity in children at high risk for type 1 diabetes. In the presymptomatic early stage of type 1 diabetes, we are attempting to prevent or delay the clinical onset of the disease through immunomodulation. After manifestation of clinical type 1 diabetes, the goal is to preserve residual beta cell function.
The study center for childhood diabetes is composed of the clinical study center unit, a regulatory and a biostatistical unit as well as a biobank and the central laboratory for clinical studies.
Study Center Units
Clinical study center
In our clinical trials, we are investigating new approaches for the treatment and prevention of type 1 diabetes. Visits and examinations of study participants take place in our spacious, modern and child-friendly clinical study center. Our team of study physicians and study nurses provide support and counseling to study participants and their families and ensure that studies are conducted according to Good Clinical Practice.
Central laboratory
The Central Laboratory team is responsible for laboratory aspects of clinical studies, such as processing, storage, and shipping of biospecimens, as well as sample testing, data collection and reporting.
Biobank
The biobank of the Institute of Diabetes Research, Helmholtz Munich, contains extensive sample material (serum, plasma, DNA, RNA, PBMC, blood, stool and urine) from study participants. Since all data obtained in our studies are intended to serve the scientific progress that could ultimately benefit patients, scientists can use the sample material for various research activities within collaborative projects. The Institute of Diabetes Research provides pseudonymized data from the data & biobank to the scientific community upon request.
Regulatory affairs
The Regulatory affairs team is responsible for regulatory and ethical committee submissions, study documents and tools, TMF maintenance, management of monitoring and audits, central data review and data cleaning, coordination of external vendors, SOPs and IMP management.
Biometrics & study design
The biometrics & study design team supports the planning and evaluation of clinical studies using appropriate statistical and epidemiological methods.
Currently Active Clinical Studies
AGONIST GmbHEnrolment of study participants ongoing:
Primary intervention study to determine whether daily administration of B. infantis EVC001 until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.
POInT Primary Oral Insulin TrialEnrolment of study participants completed; intervention phase ongoing:
1050 young children at high genetic risk for type 1 diabetes are participating in a randomized clinical trial of high-dose daily oral insulin treatment to prevent or delay the development of type 1 diabetes.
Fr1daEnrolment of study participants and intervention phase completed; follow-up phase ongoing:
220 children with presymptomatic type 1 diabetes (stage 1) are participating in a randomized clinical trial of high-dose daily oral insulin treatment to prevent or delay the development of clinical type 1 diabetes.
Currently active observational studies on type 1 diabetes development:
