Children with diabetes? How many are there and what treatment prospects do they have? The artificial pancreas is it effective? We need to pay close attention to these do-it-yourself systems trusted by the parents of diabetic children aged 0 to 6, say the Italian and international experts who have asked for new studies to be implemented soon on these devices used by the little ones. The system can be effective but not without risks such as over- and under-dosing of insulin.
Pancreas and algorithms
There are about 2,000 children under 6 in Italy with type 1 diabetes, 400 new diagnoses every year. For them it just exists an automated insulin delivery system (Automated Insulin Devices, Aid), just approved by the regulatory bodies in our country and in Europe. But for some years, dozens of people, then hundreds and now thousands, have also been experimenting with moles children “DIY artificial pancreas“, the so-called Do-It-Yourself Artificial Pancreas System (Diyaps)based on customized and “homemade” algorithms by the community of patients or by the parents themselves, also sometimes exploiting old out-of-market models of other components (pump and sensor). In this way, parents can delegate this task to an algorithm, reducing the stress and inconvenience of children and families. According to one estimate, contained in a study published in 2021 in ‘The Lancet Diabetes & Endocrinology’, there would be at least 10 thousand people who rely on ‘do it yourself’, of which 20% are under the age of 18.
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Artificial pancreas in Italy
Also in ItalyBased on these estimates, there are dozens of cases of recourse to do-it-yourself. The experts have decided to address the issue during a scientific meeting, the Congress ‘Advanced Technologies & Treatments for Diabetes’ (ATTD), underway in Berlin until 25 February, dedicated to technological innovations for the management of diabetes.
We need to speed up the studies on these DIY systems
In this context, the specialists of the Italian Society of Pediatric Endocrinology and Diabetology (Siedp) warn of the risks of using a homemade artificial pancreas in children under 6 with type 1 diabetes. This approach of homemade devices it is not shared by a large part of the scientific community which however, on the other hand, indicates the urgency of promoting research and clinical trials of more automatic systems for children under the age of 6, so that in the near future all young patients with type 1 diabetes can access these innovative devices safely. A consensus document was discussed today for the first time at the ATDT meeting by international experts and patient associations, to bring to the attention of companies and research institutions the need to accelerate the studies of these new systems which have already demonstrated optimal levels of efficacy and safety in the management and control of the disease even in the youngest.
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Artificial pancreas, because parents choose it
Why did some parents take the DIY route? In Italy and Europe at the moment there is only one prototype of an automatic device authorized for the little ones, which is insufficient – explains a note – to meet the needs of patients with type 1 diabetes in the 0-6 age group. Smaller models are needed, without an external catheter and easier to use. The Italian experts of Siedp are among the promoters of the consensus document initiative for promote the testing of more automated insulin delivery systems, bringing those developed by the parents and patients themselves out of the shadows. In detail, the invitation to companies and research institutions is to increase official studies on the artificial pancreas in the pediatric population up to 6 years of age, all without abandoning the dozens of Italian families who have adopted do-it-yourself systems while awaiting the development of research and regulatory authorizations, the experts point out.
«The artificial pancreas represents the most advanced scientific innovation for the treatment of type 1 diabetes which, despite being the least widespread form, concerns 20 million people in the world and 300 thousand in Italy, of which about 2 thousand children under the age of 6», he recalls on behalf of the pediatric diabetes community Valentine Cherubinipresident-elect of Siedp, director of the Pediatric Diabetology Unit of the Marche University Hospital of Ancona.
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Type 1 diabetes, what is it
Type 1 diabetes it is an autoimmune disease in which the immune system knocks out the insulin-producing beta cells. With no more ability to produce the hormone that regulates blood sugar, patients have to continuously monitor your blood glucose manually and manually self-inject insulin every time their blood sugar goes up, going into sudden jumps up or down, which are bad for you in the long run.
«At risk are especially the youngest children – highlights Cherubini – for whom it is difficult to manage the disease because the parents have to deal with the vivacity of the children, their activities and the ever-changing meals that cause continuous glycemic variations. THEAbove all, the artificial pancreas represents a potential solution for them»being «equipped with sensors that monitor blood glucose automatically and very frequently, and with a pump that injects insulin on the basis of needs, connected in recent years to software that “rethinks” insulin levels automatically, considering not only the blood sugar but also the activity that the little patient is carrying out».
Such systemscontinues Cherubini, «as well as improving glycemic outcomes and overall health long-term in children, reduce discomfort and improve sleep quality». Devices that infuse insulin as needed without patient intervention have been available for some years also in Italy e to date, about 18,000 out of 300,000 patients are treated with an artificial pancreas under a reimbursement regime. But among these very few children under the age of 6 use them.
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Children aged 0-6 and artificial pancreas: what the latest studies say
«To date, even if few, the works conducted to observe the effectiveness of the systems on the under 6s show good results – reports Cherubini – One of the most recentpublished last January in the ‘New England Journal of Medicine’ and also funded by the European Commission, reported a significant improvement in glycemic control in children aged 1 to 5 years with type 1 diabetes, without increasing time in hypoglycemia». In particular, says the expert, «thanks to the automatic system, the young patients exceeded the glycemic target by 8.7 percentage points compared to the control group. However, approvals for new drugs and devices for young children have traditionally been delayed due to challenges in approvals for experimentation which always takes place after satisfactory results have been obtained in adolescents and adults. On the other hand, not extending the search to these systems also contemplates possible risks deriving from the use of devices that have not yet been approved. We need to speed up so that all the little ones with type 1 diabetes can access these systems safely». Over the years, says Cherubini, «a phenomenon born of the “#WeAreNotWaiting” movement has spread and expanded, which has also landed 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 a resort to do-it-yourself artificial pancreas systems».
Building your own device can be risky
Systems «home-made and not without risk, albeit limited, such as excess and underdosing of insulin – reports the specialist – These devices are often built following the instructions of open source projects downloadable from the Internet and programmed and customized. Obviously it is safer to wait for clinical trials of devices awaiting authorization, rather than doing it yourself while waiting. But the opportunity is that this phenomenon that can no longer be ignored accelerate research to put on the market low-cost devices based on new technologies, which contribute to improving the lives especially of the little ones and their parents”. «Let’s think – he intervenes Mariacarolina Salerno, Siedp president – to enrollment in school, accomplished in serenity after the onset of the disease, or to sports and recreational activities, such as a snack with peers, to be experienced without particular worries. It also means educating children and young people in autonomy who, thanks to the system, do not feel constantly controlled by their parents. The change brought about by these technologies has also been accompanied over the years by Siedp’s training work in schools for the management of type 1 diabetes by teachers, pupils and families”.
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