An interventional study of WM3.4NR in Diabetes, sponsored by RSP Systems A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by RSP Systems A/S · Not applicable, Interventional, and Basic science
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
Subjects will collect 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →RSP Systems A/S is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects will collect spectral raman data on WM3.4NR four times a day for 30 days distributed over a time period of 60 days. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.
Device: WM3.4NR
Subjects will collect spectral raman data on WM3.4NR four times a day for the initial 30 days, distributed over a time period of 60 days. Subjects will for the remaining 60 days of measurements, distributed over 120 days collect spectral data twice a day. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.
Device: WM3.4NR
Investigational Medical Device collecting spectral raman data from tissue.
Generation and validation of predictive algorithms for determining blood glucose levels
Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid
Time frame: 7 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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RSP Systems A/S