NCT03782649

Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: RSP Systems A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Detailed description

Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Working Model 3.4NR	Investigational Medical Device collecting spectral Raman data from tissue

Timeline

• Start date: 2018-11-29
• Primary completion: 2019-06-19
• Completion: 2019-06-19
• First posted: 2018-12-20
• Last updated: 2019-12-12

Locations

1 site across 1 country: Sweden