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Clinical Assessment of a Closed-loop Insulin Delivery System

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ClinicalTrials.gov Identifier: NCT01534013
Recruitment Status : Unknown
Verified February 2012 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : February 16, 2012
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: The Imperial College Closed-Loop Insulin Delivery System

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Closed-loop Insulin Delivery System
Study Start Date : August 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. % time in euglycaemia [ Time Frame: 18 months ]
    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 :
  1. % time in hypoglycaemia [ Time Frame: 18 months ]
    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.

  2. % time spent in hyperglycaemia [ Time Frame: 18 months ]
    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.

  3. Glycaemic variability as measured by MAGE and SD [ Time Frame: 18 months ]
    Calculation using CGM data

  4. Glycaemic risk as measured by LBGI and HBG [ Time Frame: 18 months ]
    Calculation using CGM data

  5. Closed loop error grid analysis [ Time Frame: 18 months ]
    Calculation using CGM data

  6. Glucose area under the curve [ Time Frame: 18 months ]
    Calculation using CGM data

  7. Insulin requirement in units/kg/hr [ Time Frame: 18 months ]
    Calculation using average insulin delivered per hour and bodyweight



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Georgiou P, Toumazou C. Towards an ultra low power chemically inspired electronic beta cell for diabetes. Circuits and Systems, 2006. ISCAS 2006. Proceedings. 2006 IEEE International Symposium on, p. 173, 2006.
Ho M, Georgiou P, Singhal S, Oliver NS, Toumazou C. A bio-inspired closed loop insulin delivery based on the silicon pancreatic beta-cell. Circuits and Systems, 2008. ISCAS 2008. IEEE International Symposium on, pp. 1052-1055, 2008

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01534013     History of Changes
Other Study ID Numbers: CRO1710
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

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, Globin Zinc
Insulin
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents