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Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor

This study is currently recruiting participants.
Verified January 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01781533
First received: January 23, 2013
Last updated: April 23, 2013
Last verified: January 2013
History of Changes
  Purpose

To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.


Condition Intervention
Diabetes
 Procedure: algorithm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • the percentage of glucose values obtained every 15 min in predefined glucose ranges [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Injected insulin dose [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Accuracy of the glucose monitoring unit [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The absolute and relative difference between glucose monitoring readings and reference values (blood glucose) will be used to determine the accuracy of the monitoring unit


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: algorithm Procedure: algorithm

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female aged 18 to 75 years (both inclusive)
  • Informed consent obtained after being advised of the nature of the study
  • The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
  • The subject's HbA1c <= 10%
  • Body Mass Index (BMI) <= 35 kg/m2
  • The subject is treated with continuous subcutaneous insulin infusion for at least 3 month

Exclusion Criteria:

  • Subject is actively enrolled in another clinical trial or took part in a study within 30 days
  • Experienced recurrent severe hypoglycaemic unawareness
  • Total daily insulin dose >= 1.4 IU/kg
  • Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
  • Allergy against insulin Lispro
  • A history of drug or alcohol dependence
  • Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
  • Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
  • Patient is pregnant, or breast feeding during the period of the study
  • Patient donated blood in the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781533

Contacts
Contact: Stefan Korsatko, MD 43 316 385 ext 72835 stefan.korsatko@medunigraz.at
Contact: Jamala Gurban, MD 43 316 385 ext 72835 jamala.gurban@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Styria, Austria, 8010
Contact: Stefan Korsatko, MD     +43 316 385 ext 72835     stafan.korsatko@medunigraz.at    
Principal Investigator: Thomas R Pieber, MD            
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R Pieber, MD Medical University of Graz
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pieber Thomas, MD, Univ. Prof. Dr. med., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01781533     History of Changes
Other Study ID Numbers: REACTbyALGO-1
Study First Received: January 23, 2013
Last Updated: April 23, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

ClinicalTrials.gov processed this record on May 23, 2013