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

Medical University of Graz

Status

Completed

Conditions

Diabetes

Treatments

Procedure: algorithm

Study type

Interventional

Funder types

Other

Identifiers

REACTbyALGO-1

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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