Day and Night Closed-loop in Young People With Type 1 Diabetes

Summary

The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c.

This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group).

It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy.

Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose 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 HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), 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 and diabetic ketoacidosis (DKA).

Conditions

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

Interventions

DEVICE

FlorenceM (US) and FlorenceX (UK)

The automated closed loop system (FlorenceM in US) will consist of: Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Guardian3 CGM and glucose suspend feature. The automated closed loop system (FlorenceX in UK) will consist of: The DANA Diabecare R insulin pump (Sooil Development, Korea) incorporating the Dexcom G6 CGM. An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.

DEVICE

Insulin pump therapy

Subjects will continue using their own insulin pump for 6 months.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Indiana University

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Nemours Children's Health System

  collaborator OTHER

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Roman Hovorka, PhD · University of Cambridge

• Ajay Thankamony, MD · University of Cambridge

• Fiona Campbell, MD · The Leeds Teaching Hospitals NHS Trust

• Bruce Buckingham, MD · Stanford University

• Stuart Weinzimer, MD · Yale University

• Linda DiMeglio, MD · Indiana University

• Paul Wadwa, MD · University of Colorado, Denver

• Korey Hood, PhD · Stanford University

• Dana Goldman, PhD · University of Southern California

• Nikki C Davis, MD · Southampton Children's Hospital

• Louise Denvir, MD · Nottingham Children's Hospital

• Nelly Mauras, MD · Nemours Children's Health System

• Rachel Besser, MD · Oxford Children's Hospital

• Atrayee Ghatak, MD · Alder Hey Children's NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-12

Primary Completion

2020-08-27

Completion

2020-08-27

FDA Device

Yes

Countries

• United States
• United Kingdom

Study Locations