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The Global Platform for the Prevention of Autoimmune Diabetes (GPPAD) has launched the Primary Oral Insulin Trial (POInT) aimed at preventing the development of type 1 diabetes in at-risk children. MBioLIMS Biobanking® was chosen to manage the samples collected from new-borns across five sites in Europe.
What is type 1 diabetes?
Type 1 diabetes results from an autoimmune destruction of the insulin-producing beta cells within the pancreatic islets of Langerhans.
According to the International Diabetes Federation, as of 2017 an estimated 425 million people have diabetes worldwide, of which type 1 diabetes accounts for between 5 and 10 percent. Compared to other regions, Europe has the highest number of children and adolescents (0-19 years) with type 1 diabetes, with 286,000 cases and one of the highest numbers of new cases per year.
Genetic testing for susceptibility to type 1 diabetes can help identify new-borns at risk of developing auto-antibodies against their pancreatic beta cells. This development of auto-antibodies in the blood marks the start of type 1 diabetes-associated autoimmunity. Hence, biological samples are vital for conducting type 1 diabetes prevention trials.
80.000 samples of six different sample types will be registered for this study in the MBioLIMS, which makes it a key component in this clinical trial
What is the GPPAD project?
GPPAD was established in 2015 in Germany, the United Kingdom, Sweden, Belgium, and Poland with the intention to create an infrastructure for identifying new-borns at high-risk of developing type 1 diabetes to conduct primary prevention trials. The platform includes testing sites, a data coordinating centre that provides a database, data analysis, a biorepository, procedures for regulatory approval, a pharmacy, and a communication centre.
The first primary prevention trial to be conducted in the GPPAD platform is the Primary Oral Insulin Therapy (POInT). It is a randomised controlled phase II/III trial using autoantigen-based therapy. It focuses on oral insulin therapy with an objective to test its efficacy in reducing the incidence of beta- cell autoimmunity in at-risk children. The goal is to induce immune tolerance against one auto-antigen before the start of beta-cell autoimmunity. It is expected that other therapeutic approaches to prevent type 1 diabetes will be carried out within the clinical platform in the future.
How is MBioLIMS BioBanking® contributing to the GPPAD project?
In a continuation of the successful collaboration between Helmholtz Zentrum München and Modul- Bio, GPPAD will use MBioLIMS Biobanking® to manage the samples of multiple clinical studies. In the POInT study, the application supports GPPAD in effectively conducting the collection, shipment, and storage of samples and in handling the overall biosample flow among the GPPAD sites in Europe, the central laboratory in Munich, and the biobank in Luxembourg. The five European centres involved are: UZ Leuven in Belgium, Institute of Diabetes Research - Helmholtz Zentrum München in Germany, Institute of Mother and Child in Warsaw, Poland, Lund University in Sweden, and Churchill Hospital in Headington, U.K.
Dr. Florian Haupt, study coordinator at Helmholtz Zentrum München, explains: “The POInT study plans to include more than 1000 children over a period of four years. To evaluate the immune response to the treatment, up to 80.000 samples of six different sample types will be registered for this study in the MBioLIMS, which makes it a key component in this clinical trial”.
Owing to the software’s high throughput capacity, secure software, and user-friendliness, subject inclusion and consent management are centralised, while biological samples are anonymised and managed. Its traceability, advanced reporting functionalities, and seamless integration with the existing infrastructure further assist in the management of the project.
Aligning with the vision of the Helmsley Charitable Trust to improve outcomes, delay, and ultimately prevent type 1 diabetes, and thanks to Helmsley funding, GPPAD will implement a global effort to collect samples from new-borns at risk, and later from the population at large, across Europe for diagnosis and prevention.
GPPAD is an initiative funded by The Leona M. and Harry B. Helmsley Charitable Trust. Its long-term vision is to stop the trend of increasing incidence of childhood type 1 diabetes via coordinated global efforts to launch controlled preventive trials.