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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781533
• Other study ID #: REACTbyALGO-1
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: March 17, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• algorithm

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of glucose values obtained every 15 min in predefined glucose ranges		15 minutes	Yes
Secondary	Injected insulin dose		24 hours	Yes
Secondary	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	No

External Links

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