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

NCT ID: NCT01781533

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

algorithm

Group Type: EXPERIMENTAL

algorithm

Intervention Type: PROCEDURE

Interventions

algorithm

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Pieber Thomas, MD

Univ. Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas R Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

REACTbyALGO-1

Identifier Type: -

Identifier Source: org_study_id