Closing the Loop in Young Children With Type 1 Diabetes

April 1, 2013 updated by: Daniela Elleri

An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of Overnight Closed-loop Insulin Delivery Using Diluted Insulin in Comparison With Closed-loop With Non-diluted Insulin in Children With Type 1 Diabetes Aged 2 to 6 Years

The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. On both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. The study will take place at the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from paediatric diabetes clinics in England.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
        • Contact:
        • Principal Investigator:
          • Roman Hovorka, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is between 2 and 6 years of age (inclusive)
  • The subject has had type 1 diabetes, as defined by WHO criteria for at least 6 months
  • The subject will be an insulin pump user and carers will have a good knowledge of insulin dose adjustment
  • HbA1c below 12 % (108mmol/mol)

Exclusion Criteria:

  • Non-type 1 diabetes mellitus including those secondary to chronic disease
  • Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
  • Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids
  • Known or suspected allergy against insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closed-loop with diluted insulin
Insulin pump therapy using diluted insulin (20 IU/ml) will be driven by computer-based algorithm from 1700 on Day 1 until 0800 on Day 2
Procedure: Overnight closed-loop insulin delivery
Basal insulin infusion rates on insulin pump will be directed by MPC algorithm using diluted versus non-diluted insulin
Active Comparator: Closed-loop with non-diluted insulin
Insulin pump therapy using standard non-diluted insulin (100 IU/ml) will be driven by computer-based algorithm from 1700 on Day 1 until 0800 on Day 2
Procedure: Overnight closed-loop insulin delivery
Basal insulin infusion rates on insulin pump will be directed by MPC algorithm using diluted versus non-diluted insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in target
Time Frame: Between 21:00 on Day 1 and 8:00 on Day 2
Time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L)
Between 21:00 on Day 1 and 8:00 on Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time below target
Time Frame: Between 21:00 on Day 1 and 8:00 on Day 2
• Time spent with plasma glucose concentration below the target range (<3.9mmol/L)
Between 21:00 on Day 1 and 8:00 on Day 2
Glucose variability
Time Frame: Between 21:00 on Day 1 and 08:00 on Day 2
• Glucose variability as measured by standard deviation of glucose
Between 21:00 on Day 1 and 08:00 on Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Elleri

Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Roman Hovorka, PhD, University of Cambrigde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APCam10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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