96
Participants
Start Date
January 31, 2017
Primary Completion Date
July 31, 2023
Study Completion Date
July 31, 2024
Closed-loop system (Florence M or CamAPS FX)
"The automated closed-loop system (FlorenceM) will consist of:~* Sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite/Guardian 3 real time CGM and glucose suspend feature.~* An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.~The automated closed-loop system (CamAPS FX) will consist of:~* Dana R or RS insulin pump~* Dexcom G6 real-time CGM~* CamAPS FX App on an unlocked android smartphone.~Rapid acting insulin analogue will be used (insulin aspart, insulin lispro, insulin glulisine or similar or ultra-rapid insulin analogue)."
Multiple Daily Injections
"Rapid acting insulin analogue and long acting insulin analogue will be subcutaneously administered using CE-marked insulin pen devices in accordance with the manufacturer's instructions for their intended purposes.~Participants will be given long acting analogue (insulin glargine, insulin detemir or similar) once or twice daily according to their needs and boluses of rapid acting analogue (insulin aspart, insulin lispro, insulin glulisine or similar or ultra-rapid insulin analogue) when carbohydrates are consumed."
Southampton Children's Hospital, Southampton
Nottingham Children's Hospital, Nottingham
John Radcliffe Hospital, Oxford
Alder Hey Children's NHS Foundation Trust, Liverpool
St James's University Hospital, Leeds
Cambridge University Hospitals NHS Foundation Trust, Cambridge
Royal Hospital for Sick Children, Edinburgh
Collaborators (1)
Cambridge University Hospitals NHS Foundation Trust
OTHER
Alder Hey Children's NHS Foundation Trust
OTHER
Nottingham University Hospitals NHS Trust
OTHER
Oxford University Hospitals NHS Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Jaeb Center for Health Research
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
University of Edinburgh
OTHER
University of Cambridge
OTHER