There would be dozens of children under the age of six who use automatic systems with sensors and insulin pumps managed by unapproved algorithms, developed by patients or their families
The “fashion”, as often happens, comes from overseas, but this time it is good not to copy: automatic do-it-yourself artificial pancreas systems can be risky, especially in young children. These systems, which they pair blood glucose sensors and insulin pumps through algorithms developed by patients or family members of patients that have never been approved by regulators, are already quite widespread in the United States; according to the alarm raised by the experts of the Italian Society of Pediatric Endocrinology and Diabetology (SIEDP) during the «Advanced Technologies and Treatments for Diabetes» congress, even in Italy there could be dozens of children with type 1 diabetes under the age of six managed with these «do-it-yourself» tools.
Open source programs downloadable from the net
The high-tech “bricolage” that assembles sensors and insulin pumps by making them controlled by do-it-yourself algorithms was born in the United States, where they already appeared about ten years ago open source programs downloadable from the netoften conceived by patients or their family members with computer skills frustrated by the slow evolution of knowledge and above all by the long wait for permission ai
artificial pancreas systems tested in controlled clinical trials. Patients are not dissatisfied with it, but also recently the Food and Drug Administration he advised against their use and now the SIEDP experts reiterate the dangers, reporting that according to some estimates there are at least 10,000 people with type 1 diabetes in the world who rely on do-it-yourself, of which 20 percent are under 18. « Over the years, a phenomenon born from the #WeAreNotWaiting movement has spread and expanded, also arriving on social networks, which due to the limited availability of commercial versions of automatic systems has led thousands of people around the world and dozens in Italy to resort to pancreatic systems artificial DIY», observes Valentino Cherubini, president-elect of SIEDP. “These are homemade systems and not without risk, albeit limitedsuch as excess and underdosing of insulin».
A real problem
«Obviously», continues Cherubini, «it’s safer wait for clinical trials of devices awaiting authorization, rather than do it yourself while waiting. However, this phenomenon can no longer be ignored and should lead to an acceleration of research to bring low-cost devices based on new technologies to the official market, which help to improve the lives of children and their parents”. The tools approved after the trial process exist and also in Italy about 18 thousand patients with type 1 diabetes use them, but the children under six years old there are very few whys there is only one approved model for them, insufficient to satisfy needs because smaller models are needed, without an external catheter and easier to use. There aren’t many studies on children, but those that do have shown good results: in 2022 for example a research published on New England Journal of Medicine.
“It recorded a significant improvement in glycemic control in children aged between one and five years with type 1 diabetes, without increasing the time spent in hypoglycemia,” Cherubini points out. “New medicines and tools for young children are coming to patients late due to approval difficulties for experimentation, which always takes place after satisfactory results have been obtained in adolescents and adults. On the other hand, however, not expanding research on these systems entails possible risks due to the use of tools that have not yet been approved: it is therefore necessary to speed up so that all the youngest children with type 1 diabetes can access these systems safely”, concludes Cherubini .
February 22, 2023 (change February 22, 2023 | 17:28)
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