Clinical Assessment of a Closed-loop Insulin Delivery System

This study is currently recruiting participants.
Verified February 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01534013
First received: January 30, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

The purpose of the study is to assess the safety and efficacy of the Imperial College closed loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.


Condition Intervention
Type 1 Diabetes Mellitus
Device: The Imperial College Closed-Loop Insulin Delivery System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Closed-loop Insulin Delivery System

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • % time in euglycaemia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.


Secondary Outcome Measures:
  • % time in hypoglycaemia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in hypoglycaemia is to be calculated using these blood glucose values.

  • % time spent in hyperglycaemia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during patient visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.

  • Glycaemic variability as measured by MAGE and SD [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Calculation using CGM data

  • Glycaemic risk as measured by LBGI and HBG [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Calculation using CGM data

  • Closed loop error grid analysis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Calculation using CGM data

  • Glucose area under the curve [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Calculation using CGM data

  • Insulin requirement in units/kg/hr [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Calculation using average insulin delivered per hour and bodyweight


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closed-loop insulin delivery
The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes
Device: The Imperial College Closed-Loop Insulin Delivery System
The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.
Other Names:
  • Closed-loop insulin delivery system
  • Artificial pancreas
  • Bio-inspired artificial pancreas

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over 18 years of age
  • Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200nmol/L
  • Type 1 diabetes for greater than 1 year
  • Continuous subcutaneous insulin infusion for greater than 6 months
  • HbA1c < 8.5% (69mmol/mol)

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534013

Contacts
Contact: Desmond Johnston, MBChB,PhD,FRCP +442075942429 d.johnston@imperial.ac.uk
Contact: Nick Oliver, MBBS, MRCP +442033111064 n.oliver@imperial.ac.uk

Locations
United Kingdom
Imperial College London, St Mary's Campus Recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Desmond Johnston, MBChB, PhD, FRCP         
Sub-Investigator: Nick Oliver, MBBS, MRCP         
Sub-Investigator: Monika Reddy, MBChB, MRCP         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Desmond Johnston, MBChB,PhD,FRCP Imperial College London
  More Information

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01534013     History of Changes
Other Study ID Numbers: CRO1710
Study First Received: January 30, 2012
Last Updated: February 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Closed loop insulin delivery

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

ClinicalTrials.gov processed this record on April 15, 2014