Closing the Loop in Adolescents During Non-compliance Behaviours

June 26, 2012 updated by: Dr Roman Hovorka, University of Cambridge

An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment Simulating Non-compliant Behaviours in Adolescents With Type 1 Diabetes

The ultimate goal of the investigators ongoing research is the development of a closed-loop system for insulin delivery, which can help people with type 1 diabetes (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 computes 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 was evaluated both overnight and over a prolonged period of time including the day-time in children and adolescents with T1D. 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 test the performance of closed-loop further, by evaluating the system during common non-compliant behaviours in the administration of meal insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D under various "real-life mimicking" common circumstances. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy will be compared with the conventional insulin pump therapy in 12 adolescents with T1D.

Participants aged 12 to 18 years will be randomised for two 24 hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump therapy (control arm). On both occasions, participants will under-estimate and omit the meal-related insulin dose for the evening-meal and lunch, respectively. The study will take place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants recruited from paediatric diabetes clinics in England.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 12-18 years
  • Type 1 diabetes diagnosed for > 1 year
  • Insulin pump treatment for at least 3 months
  • HbA1c between 8 and 12%
  • Subject willing to perform reduction/omission of meal insulin boluses during clinical studies

Exclusion Criteria:

  • Non-type 1 diabetes mellitus
  • Physical or psychological disease likely to interfere with the normal conduct of the study
  • Current treatment with drugs known to interfere with glucose metabolism
  • Known or suspected allergy against insulin
  • Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy
  • Total daily insulin dose >= 2 IU/kg/day
  • Pregnancy, planned pregnancy, or breast feeding

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
Active Comparator: Control
Subcutaneous insulin delivery will be administered according the standard insulin pump settings
Device: standard insulin pump
Subcutaneous insulin delivery will be administered according the standard insulin pump settings
Experimental: Closed-loop
Subcutaneous insulin delivery will be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings
Device: Closed-loop
Subcutaneous insulin delivery will be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary efficacy outcome measure
Time Frame: 24 hours
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0mmol/L) between 19:00 on Day 1 and 18:00 on Day 2 (23 hours), as obtained with closed-loop insulin delivery as compared with conventional insulin pump therapy.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy outcome measure
Time Frame: 24 hours

Secondary outcomes will include:

  • Time spent with plasma glucose concentration above the target range (>10mmol/L) between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).
  • Time spent with plasma glucose concentration below the target range (<3.9mmol/L) between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).
  • Total and basal insulin delivery between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).
  • CGM glucose levels between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).
  • Overnight plasma glucose levels between 24:00 on Day 1 and 08:00 on Day 2 (8 hours)
24 hours

Collaborators and Investigators

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

Sponsor

University of Cambridge

Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators

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

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

July 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAN03

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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