This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.
Steno Diabetes Center Copenhagen (SDCC)
Gentofte Municipality, Denmark
Generation of predictive algorithms for determining blood glucose levels
Collected spectral raman data will found the development of predictive algorithms for glucose determination.
Time frame: 12 months
Validation of predictive algorithms for determining blood glucose levels
Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.
Time frame: 12 months
Risk/benefit analysis
Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects.
Time frame: 12 months
Number of encountered Device Deficiencies
Evaluation of Device Deficiencies with respect to identity, quality, durability or reliability, including malfunctions, use errors and inadequate labeling.
Time frame: 12 months
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