Diabetes
Conditions
Brief summary
Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)) will be investigated to determine the optimal calibration method in patients with type 1 diabetes
Detailed description
The subjects (Type 1 diabetes) will stay at the Clinical Research Centre for the whole period of the investigation (12 hours). Continuous blood glucose monitoring will be performed using the IR-Glucose Reader system and/or the IR-CGM system based on microdialysis. In parallel blood glucose measurements will be performed every 15 min as reference. The measurements of the sensors will be calibrated with different schemes and the difference between the calibrated glucose readings and the reference blood glucose values will be determined.
Interventions
DRUGInsulin dosing
DEVICEGlucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)
Sponsors
European Commission
Medical University of Graz
Study design
Allocation
NA
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
* Informed consent obtained after being advised of the nature of the study * Male or female aged 18 to 75 years (both inclusive) * The subject has Type 1 diabetes (as defined by WHO) for at least 24 months * Body Mass Index (BMI) \<= 35 kg/m2
Exclusion criteria
* Subject is actively enrolled in another clinical trial or took part in a study within 30 days * Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator) * A history of drug or alcohol dependence * Positive result for HIV antibodies * Positive result for Hepatitis B antigen or Hepatitis C antibodies * Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator * 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 | Description |
|---|---|---|
| difference between calibrated measurements and reference | 12 hours | The calibrated sensor signals will be compared with the reference blood glucose values. The difference between the calibrated sensor signal and the reference values will be calculated (which corresponds to the error of the sensor signal) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluate necessary run-in procedures by assessment of error over time | 12 hours | Once the difference between sensor signal and the reference values is calculated these values will be investigated by looking at the data over time which enables to detect a possible change of the difference. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Distribution of the glucose values | 12 hours | The glucose sensors will be tested over a range of different reference glucose values. The distribution of the glucose values (hypo-normo-hyperglycaemia) will be taken into account when calculating the difference (error) between the sensor- and reference value. |
| Malfunction of the systems | 12 hours | Based on the fact that the sensors are in a very early development stage possible malfunctions of the sensor systems will be recorded and categorized to: mechanical, electrical, software and other malfunctions |
Countries
Austria
Outcome results
None listed