The pilot clinical study (KidsAP01) has been completed. The study compared the use of diluted and standard strength insulin in the artificial pancreas in children aged 1 to 7 years with type 1 diabetes. The study also assessed the safety, efficacy and utility of the artificial pancreas in this age group. The primary manuscript was published in Diabetes Care (
https://doi.org/10.2337/dc18-1881(si apre in una nuova finestra)) a lay summary is available on the KidsAP project website (
http://kidsap.mrl.ims.cam.ac.uk(si apre in una nuova finestra)). The results of the pilot study informed the design of the main outcome study.
The KidsAP02 clinical study has been completed. During the 4 months when children used the closed-loop system, their glucose levels were in the target range an extra 2.1 hours per day, compared to when they used only insulin pump and glucose sensor. They spent 72% of their day with glucose levels in the target range (3.9 to 10.0mmol/L) using closed-loop, compared to 63% using pump and sensor. At the end of each 4-month period, all children had their HbA1c measured, which looks at overall blood glucose control over the previous 3 months. After children used the closed-loop system, their HbA1c was 4mmol/mol lower than when they used pump and sensor. We know that a lower HbA1c reduces the risk of long-term diabetes complications like kidney, heart and eye disease.
High glucose levels can affect brain growth and learning in young children with T1D. In the study, children spent 32% of their day with high glucose levels when using pump and sensor, but this was reduced to 23% when using closed-loop. Low glucose levels can be dangerous too, but children spent no extra time with low glucose levels when they used closed-loop.
When children used the closed-loop system, their glucose levels were most stable overnight, with more than 80% of glucose levels in the target range. Parents of children with T1D often sleep poorly because they have to get up to check glucose levels or give insulin. Using closed-loop kept glucose levels more stable at night, which could help to improve parents’ sleep.
The primary manuscript was published in the New England Journal of Medicine :
https://www.nejm.org/doi/full/10.1056/NEJMoa2111673?query=featured_endocrinology(si apre in una nuova finestra) and the University of Cambridge released a press release:
https://www.cam.ac.uk/stories/KidsArtificialPancreas(si apre in una nuova finestra).
Together with Digibete, an NHS-funded video platform, we are creating videos that show the results of the KidsAP02 study. These videos will be shared with families, healthcare professionals and the public to help spread the message about closed-loop and its benefits for very young children.
This year, the National Institute for Clinical Excellence (NICE), is publishing new guidelines on closed-loop and they will make recommendations on whether it should be available on the NHS. We have shared the study results with NICE and hope that the new guidelines will make closed-loop more accessible for children and their families.
