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| Name | Class |
|---|---|
| Medical University of Graz | OTHER |
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The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction day 1, 4, 7, 14 | Other | Patient will come to the hospital on day 1, 4, 7 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer. |
|
| Induction day 1, 7, 10, 14 | Other | Patient will come to the hospital on day 1, 7, 10 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronom CGM device | Other | Patient receives three Metronom CGM devices on day 1. On day 1, 4, 7 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | Overall percentage of sensor values which fall within ± 20 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 20% at glucose concentrations ≥100 mg/dl | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability | Percentage of sensor values which fall within ± 20 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 20% at glucose concentrations ≥100 mg/dl on different days of wear-time | 14 days |
| Reliability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ursula Morjaria, MSc | Contact | 0032(0)10 23 38 80 | umorjaria@metronomhealth.com | |
| Joris Coteur, MSc | Contact | 0032(0)10 23 38 80 | jcoteur@metronomhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Julia Mader, Ass Prof | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Austria |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| Metronom CGM device | Other | Patient receives three Metronom CGM devices on day 1. On day 1, 7, 10 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer. |
|
Percentage of sensor values which fall within ± 15 mg/dl of the mean reference values
≥100 mg/dl (cf. ISO 15197: 2013, Chapter 6.3.3) (overall, on different days of wear-time)
| 14 days |
| Reliability | Percentage of sensor values which fall within ± 30 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 30% at glucose concentrations ≥100 mg/dl (overall, on different days of wear-time) | 14 days |
| Reliability | Percentage of sensor values which fall within ± 40 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 40% at glucose concentrations ≥100 mg/dl (overall, on different days of wear-time) | 14 days |
| Accuracy | Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%. | 14 days |
| Reliability | Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15% (overall, on different days of wear-time) | 14 days |
| Reliability | Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time) | 14 days |
| Reliability | Mean (MARD) and Median Absolute Relative Difference (MedARD) with regard to reference measurements in the hypoglycaemic (≤70mg/dl), euglycaemic (70- 180mg/dl), and hyperglycaemic (≥180mg/dl) area (overall, on different days of weartime) | 14 days |
| Reliability | Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time) | 14 days |
| Reliability | Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time) | 14 days |
| Steno diabetes center | Copenhagen | Denmark |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |