ESPE2023 Poster Category 2 Late Breaking (77 abstracts)
Results from a Multi-Stakeholder Meeting on Medical Devices in Paediatric Type I Diabetes
Torben Biester 1 , Felix Reschke 1 , Thomas Danne 1 , Marc Julien 2 , Irja Lusar 3 , Katharine Cheng 4 , Maria Cavaller-Bellaubi 5 , Michelle Katz 6 , Elisabeth Niemoeller 7 , Eric Renard 8 , Maren Sturny 9 , Robert Geertsma 10 & Gilles Vassal 11
1AUF DER BULT, Diabetes Center for Children and Adolescents, Hannover, Germany. 2Diabeloop, Grenoble, France. 3, Institute of Medical Microbiology, University of Tartu, Tartu, Estonia. 4former employee of Johnson and Johnson, High Wycombe, United Kingdom. 5EURORDIS-Rare Diseases Europe, Paris, France. 6Eli Lilly, Newtonville, USA. 7Sanofi Diabetes, Frankfurt, Germany. 8Department of Endocrinology, Diabetology and INSERM Clinical Investigation Centre 1411, Montpellier University Hospital, Montpellier, France. 9author, patient advocate (#dedoc° voices program, INPACT leading team), Munich, Germany. 10Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands. 11Department of Pediatric and Adolescent Oncology, Gustave Roussy Comprehensive Cancer Center and Paris Saclay University, Villejuif, France
Objectives: To discuss all challenges involved with providing children (including the very young) and adolescents with diabetes (CwD) with the latest appropriate technology, such as automated insulin delivery systems (AIDs), to manage their blood glucose and help improve their quality of life and suggest ways in which access to new types of devices available to adults can be improved for children with T1D.
Methods: In connection to the ATTD (Advanced Technologies & Treatment for Diabetes) congress in 2023 the “conect4children.org” network organized a multi stakeholder meeting to discuss barriers in providing medical devices to children and adolescents with type 1 diabetes with a focus on pre-schoolers. After announcement, stakeholders were asked to apply to this meeting. A coordinating program committee planned the meeting and a balanced selection of participants from relevant interest groups attended, including academics, clinicians, industry, regulators, patient advocates.
Results: 125 participants took part in the hybrid in-person/virtual 1-day meeting, in person and by web portal (interest groups: 50 academia/research, 21 advocates for CwD, 26 industry, 28 regulatory). Three plenary sessions with 16 presenters and 3 panel discussion with 19 participants were held.
Discussion: The most advanced appropriate technology is often unavailable to children with T1D in Europe.
Main issues highlighted were: •Lack of long-term evidence of benefits/clinical effectiveness and safety of AIDs in very young children • Regulatory approval processes are very lengthy and expensive for sponsors in EU • Market access is variable across countries, and even within countries, depending on the proximity of patient to specialist centres (or their ability to travel) • Reimbursement depends on where the patient lives Results of this meeting will be published and reported to the EU Commission in order to accelerate access to technology and improve therapy for CwD regardless of their age and place of living.
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