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CompletedNCT00535483Updated Apr 4, 2014

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

An observational study in Type 1 Diabetes, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-04-04.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
4
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • blood microdialysis
  • glucose monitoring
  • glucose control
  • automated blood sampling
  • online-sensor
  • algorithm
  • type 1 diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 4 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Time perspective
Prospective
Enrollment
4 participants (actual)
06

Study locations

1 site
  • Medical University Graz - Clinical Research Center
    Graz, Styria 8036, Austria
07

References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00535483
Lead sponsor
Medical University of Graz
First posted
Sep 26, 2007
Start date
Aug 2007
Completion
Sep 2007
Last update
Apr 4, 2014

Study contacts

Thomas R Pieber, MD
principal investigator · Medical University Graz, Graz, Austria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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