A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest
Biester, Torben Reschke, Felix Danne, Thomas Julien, Marc Lutsar, Irja Cheng, Katharine Cavaller-Bellaubi, Maria Katz, Michelle Niemöller, Elisabeth Renard, Eric
Biester, Torben
Reschke, Felix
Danne, Thomas
Julien, Marc
Lutsar, Irja
Cheng, Katharine
Cavaller-Bellaubi, Maria
Katz, Michelle
Niemöller, Elisabeth
Renard, Eric
Series / Report no.
Open Access
Type
Journal Article
Review
Article
Review
Article
Language
en
Date of publication
2025-09-15
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest
Translated Title
Published in
J Pediatr Endocrinol Metab 2025; 38(10):1001-1015
Abstract
INTRODUCTION: Medical devices for glycaemic control have revolutionised the lives of people with type 1 diabetes (TD1), yet providing children and adolescents with T1D with suitable automated insulin delivery (AID) systems remains challenging, leading to unmet medical needs.
CONTENT: The conect4children network organised an international multi-stakeholder meeting in conjunction with the Advanced Technologies and Treatment in Diabetes (ATTD) 2023 congress to discuss how to improve access to suitable AID systems for young people with T1D.
SUMMARY: A total of 125 participants attended the 1-day meeting (academics/clinicians, n=50; advocates for children with T1D, n=21; industry, n=26; regulators, n=28). The attendees discussed treatment options, including available medical devices and their limitations. Carers and adolescents described their experiences related to T1D and accessing the latest technologies. The most advanced appropriate technology is often unavailable to children with T1D in Europe. The challenges and potential solutions for providing AID systems to very young children were discussed in the context of understanding the differences in European and United States medical device regulations. The main issues highlighted were a lack of long-term evidence of benefits/clinical effectiveness and safety of AIDs in very young children, lengthy and expensive regulatory approval processes in the European Union, variable market access and reimbursement across countries and even within countries, depending on the proximity of the patient to specialist centres (or their ability to travel).
OUTLOOK: All stakeholders need to take their responsibility and cooperate to ensure that young people with T1D have access to appropriate technology and therapy regardless of their age and place of living.