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D4Kids

Children living with Type 1 diabetes have to sustain the burden of frequently checking their glycaemia (for meals and physical activity). The D4Kids project has developed a medical device for regulating insulin delivery in real time that is tailored to these children’s needs. The system allows remote monitoring by parents.


Publié le 6 janvier 2021


D4Kids : EITHealth 18178 Diabeloop for Children

Children living with Type 1 diabetes have to sustain the burden of frequently checkingtheir glycaemia (for meals and physical activity). The D4Kids project has developed a medical device for regulating insulin delivery in real time that is tailored to these children’s needs. The system allows remote monitoring by parents.


 

Starting date : Jan 2018 > Dec 2018    Lifetime:12 months


Program in support : 

EITHealth 18178 Diabeloop for Children


 

Status project : complete


CEA-Leti's contact: Maeva Doron 

                                 Patrick Boisseau                             

                                               

 

Project Coordinator: CEA-Leti 


Partners:  

  • Katholieke Universiteit Leuven (BE)

  • Profil Institut für Stoffwechselforschung GmbH 5DE)

  • CERITD, Diabeloop SA

Target market: n/a


Investment:  € 9.1 m.

EC Contribution€ 0.5 m.

Stakes

  • CEA-Leti has mainly contributed to the technological aspect of the project and, more specifically, to data analysis, algorithm development and establishment of a bio-regulation computing library in compliance with regulatory rules governing medical devices. The project team initially received data from clinicians, who provided information on the children's normal treatment. This included glucose measurements from Continuous Glucose Measurement (CGM) sensors, insulin delivery with either bolus and basal doses, meal time and size. 

  • This allowed us to compare, for example the glycemic trends of children and various populations already on CEA-Leti databases (adults using open-loop and closed-loop systems). This European project has been undertaken in parallel with the work of a laboratory developing an artificial pancreas for adults, which combines CEA-Leti and partners Diabeloop SA (medical device manufacturer) and CERITD (diabetologists and clinical research organization). 


  • The medical device for adults was CE-marked in autumn 2018 and the children's device could take advantage of previous developments for adults. Most of the bioregulation algorithm is based on the Hovorka model (Hovorka et al. 2002, 2004); its personalization step is of prime importance. We used a Model Predictive Control approach because the model's capacity to understand the patient physiology at any instant was crucial to determining the right insulin dose to be delivered at the right time. On completion of the project in 2019, the prototype was used in clinical trials in France and Belgium. Some 25 children were equipped with the child's artificial pancreas during 6 weeks of everyday life. Child patients, their parents and pediatric diabetologists are very enthusiastic about the results. In May 2019, EITHealth selected Diabeloop SA as a D4Kids project partner to represent EITHealth at the EIT Innovator Awards.




OBJECTIVES

  • Diabetes in children (6 to 10 years old) is characterized by high insulin sensitivity and high blood glucose variability due to unpredictable physical activity and higher glycemic response to carbohydrate intake. 


  • Diabeloop’s artificial pancreas adaptation to children started with a pilot study to collect glucose and insulin data of a few children treated with an insulin pump over a period of 4 weeks. Based on this data, our EIT Health project focused on adapting the closed loop system along two axes: fine-tuning of entry parameters and adaptation of both the closed-loop algorithm and the HMI (Human Machine Interface). The D4KIDS solution is to be validated clinically in a randomized cross-over design with 6 children during 2 days in KU Leuven under CERITD promotion. 

  • A complementary study (KCA) will be conducted on 24 diabetic children in 2 hospitals in France. Ergonomy and user-friendliness of the interface were assessed and CERITD elaborated the educational kit for children, parents, and caregivers, and test in KU Leuven. Diabeloop defined with Profil a penetration access strategy for the new product in European countries.


IMPACT

  • A first impact is removal of a considerable burden from the daily lives of both children and their families: fewer mild hypoglycemic events (several a week) and severe hypoglycemia at night. A second impact is reduction of long-term complications, thereby greatly reducing the costs of T1DM throughout the patient’s life. The artificial pancreas for children (6-12 years) DBLK will undoubtedly be a worldwide innovation. In 2019, EITHealth provided funding for a new project dedicated developing an artificial pancreas for teenagers.