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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01781533

Enrollment

Registered

2013-02-01

Start date

2013-01-31

Completion date

2015-01-31

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

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

Interventions

PROCEDUREalgorithm

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026