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| Name | Class |
|---|---|
| European Commission | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin dosing and glucose sensors | Experimental | To test the glucose sensors different levels of glycemia are needed. To provoke different glycemic levels the following intervention will be performed: Lunch (with fast glucose absorption characteristics) will be served. Up to 30 minutes after the usual insulin dosing time, the subjects will take his/her lunch dose of insulin adjusted to the chosen lunch plus additional approximately 25% (in the range of 0-50% according to the discretion of the Investigator) of insulin - in order to provoke moderate postprandial hypoglycaemia with glucose values < 70 mg/dl. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin dosing | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| difference between calibrated measurements and reference | 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) | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate necessary run-in procedures by assessment of error over time | 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. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the glucose values | 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. | 12 hours |
| Malfunction of the systems |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R Pieber, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8010 | Austria |
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| Label | URL |
|---|---|
| Website of the project which is funded by the European Commission | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D000069057 | Insulin Detemir |
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany) | Device |
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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 |
| 12 hours |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |