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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
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.
Medical University of Graz
Graz, Austria
Steno diabetes center
Copenhagen, Denmark
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
Time frame: 14 days
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
Time frame: 14 days
Reliability
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)
Time frame: 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)
Time frame: 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)
Time frame: 14 days
Accuracy
Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%.
Time frame: 14 days
Reliability
Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15% (overall, on different days of wear-time)
Time frame: 14 days
Reliability
Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)
Time frame: 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)
Time frame: 14 days
Reliability
Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)
Time frame: 14 days
Reliability
Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)
Time frame: 14 days
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