The artificial pancreas in very young children with T1D-pilot-KidsAP01
Research type
Research Study
Full title
An open-label, multi-centre, randomised, 2-period cross-over study to assess the efficacy and safety of closed loop insulin delivery using diluted insulin in comparison with closed loop with non-diluted insulin over 21 days in children with type 1 diabetes aged 1 to 7 years in the home setting
IRAS ID
223898
Contact name
Nicole Barber
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study will evaluate the use of the Artificial Pancreas (or closed loop system) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. This is a feasibility study to pilot the setup of a large-scale outcome trial and to address the specific needs of this population. The results of the pilot trial will feed into the design of the outcome study. The KidsAP project is funded by the European Commission’s Horizon 2020 Framework Programme.
In this study we will compare closed loop insulin delivery using standard strength insulin to closed loop use with diluted insulin in very young children with T1D. Diluted insulin is a standard treatment approach for children with low insulin requirements. We hypothesize that diluted insulin will lead to more stable glucose levels by reducing inaccuracies caused by delivery of minute amounts of insulin. These inaccuracies may result from pump plunger micro-jumps, tissues pressure build-up, and infusion set kinking. 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 an open-label, multi-centre, multinational, randomised, two-period crossover design contrasting closed loop glucose control using diluted insulin and closed loop using standard insulin strength under free-living home conditions. The two intervention periods will last 3 weeks each with a 1 to 4 week washout period in between. The order of the two interventions will be random. Up to 30 young children aged 1 to 7 years with T1D on insulin pump therapy will be recruited through outpatient diabetes clinics at participating clinical centres to allow for 24 completed subjects available for assessment in each of the study arms.
Prior to the use of study devices, participants and parents/guardians as well as carers at nursery or school will receive training by the research team on the safe use of the study device. During the intervention periods, subjects and parents/guardians will use the closed loop system for 21 days under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff.REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/0576
Date of REC Opinion
18 Apr 2017
REC opinion
Favourable Opinion