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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01781533
First received: January 23, 2013
Last updated: January 30, 2014
Last verified: August 2013
  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:


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: 20
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781533

Locations
Austria
Medical University of Graz
Graz, Styria, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R Pieber, MD Medical University of Graz
  More Information

Additional Information:
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: January 30, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

ClinicalTrials.gov processed this record on July 28, 2014