The Artificial Pancreas in Very Young Children With T1D - Pilot (KidsAP01)

Summary

The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme. The project evaluates the use of the Artificial Pancreas (or closed loop systems) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial 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.

In this study the investigators 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. The investigators hypothesize that diluted insulin will lead to more stable glucose levels by reducing inaccuracies accentuated by delivery of minute amounts of insulin (frequently less than 0.1U/h \[1μl/h with standard strength insulin\] in small children compared to 1U/h in adults). 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 weeks washout period in between. The order of the two interventions will be random. A total of 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 will receive appropriate training by the research team on the safe use of the study pump and continuous glucose monitoring system, and the hybrid closed loop insulin delivery system. Carers at nursery or school may also receive training by the study team if required. 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.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/l as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.

Conditions

• Type 1 Diabetes Mellitus

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.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• University of Luxembourg

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Jaeb Center for Health Research

  collaborator OTHER

• University of Cambridge

  lead OTHER

Principal Investigators

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

• Carlo Acerini, MD · Department of Paediatrics, University of Cambridge, UK

• Carine de Beaufort, PhD · Clinique Pédiatrique de Luxembourg, University of Luxembourg, Luxembourg

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

• Elke Fröhlich-Reiterer, MD · Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria

• Sabine Hofer, MD · Department of Pediatrics I, Medical University of Innsbruck, Innsbruck, Austria

• Thomas Kapellen, MD · Division for Paediatric Diabetology, University of Leipzig, Leipzig, Germany

• Birgit Rami-Merhar, MD · Deptartment of Pediatrics, Medical University of Vienna, Vienna, Austria

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

1 Year

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-08

Primary Completion

2018-05-11

Completion

2018-05-11

Countries

• Austria
• Germany
• Luxembourg
• United Kingdom

Study Locations