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
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.
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