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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781533
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz

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

Condition or disease Intervention/treatment
Diabetes Procedure: algorithm

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2013
Primary Completion Date : January 2015
Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: algorithm Procedure: algorithm

Primary Outcome Measures :
  1. the percentage of glucose values obtained every 15 min in predefined glucose ranges [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. Injected insulin dose [ Time Frame: 24 hours ]
  2. Accuracy of the glucose monitoring unit [ Time Frame: 24 hours ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781533

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

Additional Information:
Responsible Party: Pieber Thomas, MD, Univ. Prof. Dr. med., Medical University of Graz Identifier: NCT01781533     History of Changes
Other Study ID Numbers: REACTbyALGO-1
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015