Closed Loop From Onset in Type 1 Diabetes

NAActive, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

July 31, 2023

Study Completion Date

July 31, 2024

Conditions
Diabetes MellitusType 1 Diabetes
Interventions
DEVICE

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)."

OTHER

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."

Trial Locations (7)

SO16 6YD

Southampton Children's Hospital, Southampton

NG5 1PB

Nottingham Children's Hospital, Nottingham

OX3 9DU

John Radcliffe Hospital, Oxford

L12 2AP

Alder Hey Children's NHS Foundation Trust, Liverpool

LS9 7TF

St James's University Hospital, Leeds

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

EH9 1LF

Royal Hospital for Sick Children, Edinburgh

Sponsors
All Listed Sponsors
collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

collaborator

Alder Hey Children's NHS Foundation Trust

OTHER

collaborator

Nottingham University Hospitals NHS Trust

OTHER

collaborator

Oxford University Hospitals NHS Trust

OTHER

collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

collaborator

Jaeb Center for Health Research

OTHER

collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

collaborator

University of Edinburgh

OTHER

lead

University of Cambridge

OTHER