CamAPS FX is beneficial for young children with type 1 diabetes, latest evidence shows

A leading closed-loop app which mimics the key functions of a healthy pancreas significantly improves glycaemic control in very young children with type 1 diabetes, new research has identified.

Published in The New England Journal of Medicine (NEJM), the findings highlight promising results from the KIDSAP02 trial which demonstrates that the CamAPS FX is much safer than sensor-augmented pump therapy for children aged between one and seven with type 1 diabetes.

This is the first published data of sufficient duration to report on the safety and efficacy of glycated haemoglobin outcomes in very young children using hybrid closed-loop therapy.

Professor Roman Hovorka, Professor of Metabolic Technology, Department of Paediatrics, University of Cambridge and founder of CamAPS FX said: “This is the first time we have been able to evidence that our hybrid closed-loop system is safe and more effective than standard of care for very young people who are especially vulnerable and at risk of dangerously high blood glucose levels.

“With these new results clinicians have the evidence to show more clearly the potential benefits of what may become a new standard of care for very young children with type 1 diabetes.”

Young children with type 1 diabetes are particularly at risk of dangerously low blood glucose levels and high blood glucose levels, which is associated with lower IQ scores and slower brain growth.

While continuous glucose monitoring (CGM) devices and insulin pump therapy use is increasing in very young children and has been associated with reductions in severe hypoglycaemia and diabetic ketoacidosis events as well as less hypoglycaemia overall, it has not been shown to improve glycaemic control in this age group.

The potential of innovative hybrid closed-loop systems, where an algorithm automatically adjusts insulin delivery based on real-time sensor glucose levels, have been widely anticipated to transform the lives of very young children with type 1 diabetes.

This study demonstrates that by using a hybrid closed loop system, CamAPS FX, very young children are able to improve glycaemic control by reducing their average blood glucose levels – a measurement of a molecule known as glycated haemoglobin or HbA1c.

At baseline, average HbA1c levels were 7.3% and at 16 weeks this was reduced by 0.7 percentage points. Additionally, children using CamAPS FX spent around three-quarters of their day (72.6%) in the target range for their glucose levels, almost nine percentage points higher compared to the control period, accounting for an additional 125 minutes per day in the target range.

This is particularly noteworthy as the study participants had good glycaemic control to begin with and it is often hard to improve glucose control without having more hypoglycaemia events.

Parental fear of hypoglycaemia particularly overnight is common and coupled with hypoglycaemia unawareness contributes to young children not meeting recommended glycaemic targets or achieving optimal glycaemic control only at the expense of excessive caregiver input.

This often leads to high management burden and reduced quality of life for the whole family. In this study children spent less than a quarter (22.9%) of their time with high glucose levels while using CamAPS FX, almost nine percentage points lower than during the control period. There was no difference between the two groups in the time spent in hypoglycaemia.

Additionally, the app was demonstrated to improve sleep quality – one of the biggest challenges reported by families of young children with type 1 diabetes.

Researchers found that more than 80% of overnight sensor readings were within the target range, showing that hybrid closed-loop therapy addresses the night-time problem more effectively than sensor-augmented pump therapy.

Closed-loop usage was consistently high averaging at 93%, supporting the longer-term usability of the system in this age-group, and is like closed-loop usage over 26 weeks in children aged 6-13 years in other studies.

Dr Julia Ware, primary investigator and Clinical fellow, Wellcome-MRC Institute of Metabolic Science, said: “Very young children are extremely vulnerable to changes in their blood glucose levels.

“High levels in particular can have potentially lasting consequences to their brain development. On top of that, diabetes is very challenging to manage in this age group, creating a huge burden for families.”

She added: “CamAPS FX led to improvements in several measures, including hyperglycaemia and average blood glucose levels, without increasing the risk of hypos. This is likely to have important benefits for those children who use it.

“Parents have described our artificial pancreas as life changing as it meant they were able to relax and spend less time worrying about their child’s blood sugar levels, particularly at nighttime.

“They tell us it gives them more time to do what any normal family can do, to play and do fun things with their children.”

CamAPS FX is available as part of a NHS England HCL pilot and through a number of NHS trusts across the UK, including Cambridge University Hospitals NHS Foundation Trust.

To access this study, click here.

Photo by Caleb Woods on Unsplash