Closed Loop Insulin Therapy in Type 1 Diabetics Based on Blood Microdialysis, Online Sensors and an eMPC Algorithm
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.
1 other identifier
observational
4
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 24, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedApril 4, 2014
April 1, 2014
September 24, 2007
April 3, 2014
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Graz - Clinical Research Center
Graz, Styria, 8036, Austria
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R Pieber, MD
Medical University Graz, Graz, Austria
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 24, 2007
First Posted
September 26, 2007
Study Start
August 1, 2007
Study Completion
September 1, 2007
Last Updated
April 4, 2014
Record last verified: 2014-04