CClinicalTrials.gg
CompletedNCT01781533Updated Mar 18, 2015

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

An interventional study of algorithm in Diabetes, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    algorithm

    Procedure: algorithm

Interventions

  • Procedurealgorithm
06

What researchers measure

Primary outcomes

  1. the percentage of glucose values obtained every 15 min in predefined glucose ranges

    Time frame: 15 minutes

Secondary outcomes

  1. Injected insulin dose

    Time frame: 24 hours

  2. 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

    Time frame: 24 hours

07

Study locations

1 site
  • Medical University of Graz
    Graz, Styria 8010, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01781533
Lead sponsor
Medical University of Graz
Responsible party
Pieber Thomas, MD (Univ. Prof. Dr. med., Medical University of Graz) — Principal investigator
First posted
Feb 1, 2013
Start date
Jan 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Mar 18, 2015

Study contacts

Thomas R Pieber, MD
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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