Closing the Loop in Adolescents During Non-compliance Behaviours

This study has been completed.
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge
ClinicalTrials.gov Identifier:
NCT01629277
First received: April 4, 2011
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Closed-loop
Device: standard insulin pump
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 24-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment Simulating Non-compliant Behaviours in Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Primary efficacy outcome measure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Secondary efficacy outcome measure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    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)


Enrollment: 12
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01629277

Locations
United Kingdom
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Roman Hovorka, PhD University of Cambridge
  More Information

Additional Information:
Publications:
Responsible Party: Dr Roman Hovorka, Principal Research Associate, University of Cambridge
ClinicalTrials.gov Identifier: NCT01629277     History of Changes
Other Study ID Numbers: DAN03
Study First Received: April 4, 2011
Last Updated: June 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Cambridge:
Closed-loop insulin delivery
Non-compliant behaviours during adolescence

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

ClinicalTrials.gov processed this record on July 22, 2014