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Closed Loop Insulin Therapy in Type 1 Diabetics Based on Blood Microdialysis, Online Sensors and an eMPC Algorithm

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00535483
First received: September 24, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.

It is the aim of this study to evaluate the feasibility to establish glycaemic control in type 1 diabetic subjects over a period of 30 hours by manually combining these three - previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a laptop-based computer algorithm).


Condition
Type 1 Diabetes

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: An Open, Mono-Centre Pilot Study to Investigate a Novel Technique to Establish Glycaemic Control for Critically Ill Patients, Tested in Type 1 Diabetic Subjects for a Period of 30 Hours.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Enrollment: 4
Study Start Date: August 2007
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent obtained before any trial-related activities
  • Age of analysable subjects in the range from 18 to 65 years
  • Type 1 diabetes (Treatment with multiple daily injection for more than 12 months)

Exclusion Criteria:

  • Severe acute and/or chronic diseases
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • Taking of any vasoactive substances or anticoagulation medication.
  • Diseases of the skin which could interfere with application of the catheters.
  • Pregnancy or breastfeeding
  • Bleeding disorder
  • Known heparin allergy or heparin intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535483

Locations
Austria
Medical University Graz - Clinical Research Center
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R Pieber, MD Medical University Graz, Graz, Austria
  More Information

Additional Information:
(CLINICIP (background information about the overall project))  This link exits the ClinicalTrials.gov site
(Healthsite (background information to the study site and investigators))  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00535483     History of Changes
Other Study ID Numbers: ABS3
Study First Received: September 24, 2007
Last Updated: September 24, 2007
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
blood microdialysis
glucose monitoring
glucose control
automated blood sampling
 online-sensor
algorithm
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013