Home Testing of Day and Night Closed Loop With Pump Suspend Feature

Summary

The main study objective is to determine whether day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone.

This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed loop system combined with pump suspend feature (intervention group) or by sensor augmented insulin pump therapy (control group).

It is expected that up to 100 subjects, aiming for 84 randomised subjects \[42 youth (6 to 21 years), and 42 adults (22 years and older)\], with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres. Subjects who drop out within the first four weeks of the intervention may be replaced. Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study CGM device.

Subjects in the intervention group will receive appropriate training in the safe use of closed loop insulin delivery system and pump suspend feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in the time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12 week free living phase. Secondary outcomes are HbA1 at the end of treatment period, the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Glucose Metabolism Disorders
• Endocrine System Diseases
• Autoimmune Diseases

Interventions

DEVICE

FlorenceM

The automated closed loop system (FlorenceM) will consist of: * Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family 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.

DEVICE

Medtronic insulin pump 640G

Next generation sensor-augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family real time CGM. Glucose suspend features will be turned off.

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Jaeb Center for Health Research

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• International Diabetes Center at Park Nicollet

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• University of Cambridge

  lead OTHER

Principal Investigators

• Roman Hovorka, PhD · Department of Paedatrics, University of Cambridge, UK

• David B Dunger, Prof · Department of Paedatrics, University of Cambridge, UK

• Fiona Campbell, MD · St James's University Hospital, Leeds, UK

• Amy Criego, Prof · International Diabetes Center at Park Nicollet, Minneapolis, USA

• Mark Evans, MD · Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK

• Lalantha Leelarathna, PhD · Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, UK

• Richard Bergenstal, Prof · International Diabetes Center at Park Nicollet, Minneapolis, USA

• Viral Shah, MD · Barbara Davis Center for Childhood Diabetes, Aurora, USA

• Daniela Elleri, MD · Endocrine/Diabetes Department, Royal Hospital for Sick Children, Edinburgh, UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• United States
• United Kingdom

Study Locations