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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz - Clinical Research Center

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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.

Important dates

Study start: 2007
Study completion: 2007
First posted: Sep 26, 2007
Registry last updated: Apr 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed