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

An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Procedure: algorithm

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: algorithm	Procedure: algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the percentage of glucose values obtained every 15 min in predefined glucose ranges	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injected insulin dose		24 hours
Accuracy of the glucose monitoring unit	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	24 hours

Collaborators and Investigators

• Sponsor: Medical University of Graz

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: REACTbyALGO-1