Closing the Loop in Young Children With Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Cambridge.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Daniela Elleri, University of Cambridge
ClinicalTrials.gov Identifier:
NCT01557634
First received: March 14, 2012
Last updated: April 1, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Procedure: Overnight closed-loop insulin delivery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Time in target [ Time Frame: Between 21:00 on Day 1 and 8:00 on Day 2 ] [ Designated as safety issue: No ]
    Time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L)


Secondary Outcome Measures:
  • Time below target [ Time Frame: Between 21:00 on Day 1 and 8:00 on Day 2 ] [ Designated as safety issue: Yes ]
    • Time spent with plasma glucose concentration below the target range (<3.9mmol/L)

  • Glucose variability [ Time Frame: Between 21:00 on Day 1 and 08:00 on Day 2 ] [ Designated as safety issue: No ]
    • Glucose variability as measured by standard deviation of glucose


Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557634

Contacts
Contact: Daniela Elleri, MD +44 1223 7969069 de250@medschl.cam.ac.uk

Locations
United Kingdom
Wellcome Trust Clinical Research Facility, Addenbrooke's hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Janet Allen, RN    +44 1223 769064    ja385@medschl.cam.ac.uk   
Principal Investigator: Roman Hovorka, PhD         
Sponsors and Collaborators
Daniela Elleri
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Roman Hovorka, PhD University of Cambrigde
  More Information

Publications:
Responsible Party: Daniela Elleri, Clinical Research Fellow, University of Cambridge
ClinicalTrials.gov Identifier: NCT01557634     History of Changes
Other Study ID Numbers: APCam10
Study First Received: March 14, 2012
Last Updated: April 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014