Type 1 Diabetes Clinical Trial
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.
| Verified date | April 2014 |
| Source | Medical University of Graz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Graz - Clinical Research Center | Graz | Styria |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Graz |
Austria,
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