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
1 other identifier
interventional
20
1 country
1
Brief Summary
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 18, 2015
March 1, 2015
2 years
January 23, 2013
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
the percentage of glucose values obtained every 15 min in predefined glucose ranges
15 minutes
Secondary Outcomes (2)
Injected insulin dose
24 hours
Accuracy of the glucose monitoring unit
24 hours
Study Arms (1)
algorithm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, Styria, 8010, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R Pieber, MD
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ. Prof. Dr. med.
Study Record Dates
First Submitted
January 23, 2013
First Posted
February 1, 2013
Study Start
January 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 18, 2015
Record last verified: 2015-03