Skip to main content
OpenTrials
Completed

NCT Number: NCT01629277

Closing the Loop in Adolescents During Non-compliance Behaviours

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop

Device

Subcutaneous insulin delivery will be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings

standard insulin pump

Device

Subcutaneous insulin delivery will be administered according the standard insulin pump settings

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.