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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Procedure: algorithm

• Registration Number: NCT01781533
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
algorithm	algorithm	-

Primary Outcome Measures

Name	Time	Method
the percentage of glucose values obtained every 15 min in predefined glucose ranges	15 minutes

Secondary Outcome Measures

Name	Time	Method
Injected insulin dose	24 hours
Accuracy of the glucose monitoring unit	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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria