FASter insulin in closed-loop Technology in children (FAST-Kids)
Research type
Research Study
Full title
A randomised crossover study comparing hybrid closed-loop insulin delivery using ultra-rapid acting insulin to hybrid closed-loop insulin delivery using standard rapid-acting insulin in children with type 1 diabetes in the home setting (FAST-Kids).
IRAS ID
287595
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust jointly with University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary: The study will evaluate the use of ultra-rapid acting insulin in a closed-loop insulin delivery system in 2-6 year old children with type 1 diabetes (T1D).
The purpose of the trial is to determine whether closed-loop insulin delivery using faster insulin aspart, an ultra-rapid acting insulin, will improve glucose control as measured by time within the target glucose range compared with closed-loop insulin delivery using standard insulin aspart in very young children.
This study builds on previous and on-going studies of closed loop systems that have been performed in Cambridge in children and adolescents with T1D in clinical research facilities and in the home setting.
The study adopts a double-blind, multi-centre, randomised, crossover study design, contrasting closed-loop insulin delivery using faster insulin aspart with closed-loop insulin delivery using standard insulin aspart in very young children in the home setting.
Two intervention periods will last 8 weeks each. The order of the two interventions will be random and participants and the research team will be blinded to the allocated order of interventions.
Up to 30 young children aged 2-6 years with T1D on insulin pump therapy will be recruited through outpatient diabetes clinics at participating clinical centres to allow for 24 completed subjects.
Prior to the use of study devices, participants and parents/guardians as well as carers at nursery or school will receive appropriate training by the research team on the safe use of the study devices including the insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system.During the intervention periods, subjects and parents/guardians will use the closed loop system for 8 weeks under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff.
Summary of Results: Managing type 1 diabetes in very young children can be challenging because blood glucose levels can change quickly and children are often unable to recognise or communicate symptoms of low blood glucose (hypoglycaemia). Hybrid closed-loop systems, sometimes called "artificial pancreas" systems, automatically adjust insulin delivery based on continuous glucose monitoring and can help improve diabetes management.
This study investigated whether a newer, faster-acting insulin (Fiasp) could improve glucose control when used with the CamAPS FX hybrid closed-loop system, compared with the standard rapid-acting insulin aspart currently used by many children with type 1 diabetes.
Twenty-five children with type 1 diabetes, with an average age of just over five years, took part in the study. Each child used both insulin types with the CamAPS FX system during different study periods, allowing researchers to directly compare the two approaches.
The study found that both insulin types performed equally well. Children spent around 64–65% of the time within their target glucose range regardless of which insulin was used. There were also no meaningful differences in the amount of time spent with low blood glucose levels, very high glucose levels, or overall glucose stability.
Importantly, no episodes of severe hypoglycaemia or diabetic ketoacidosis (a serious diabetes complication) occurred during the study. Parents reported similar levels of diabetes-related stress and concern about low blood glucose with both treatments, although there was a small trend towards less worry about hypoglycaemia when using Fiasp.
Overall, the results showed that using faster-acting insulin (Fiasp) with the CamAPS FX hybrid closed-loop system is safe and effective in very young children with type 1 diabetes, but it did not provide significant improvements in glucose control compared with standard insulin aspart. These findings help healthcare professionals and families make informed decisions about insulin options when using hybrid closed-loop technology.
The results were published in the journal Diabetes Technology & Therapeutics in 2023.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0001
Date of REC Opinion
12 Feb 2021
REC opinion
Further Information Favourable Opinion