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

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ClinicalTrials.gov Identifier: NCT00535483
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : April 4, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease
Type 1 Diabetes

Study Design

Study Type : Observational
Actual Enrollment : 4 participants
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.
Study Start Date : August 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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:
ClinicalTrials.gov Identifier: NCT00535483     History of Changes
Other Study ID Numbers: ABS3
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014

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