NCT03782441

Study of a Novel Non-invasive Glucose Monitoring Device

A Pilot Study of a Novel Non-invasive Glucose Monitoring Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: RSP Systems A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Detailed description

The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Prototype 0.5	Investigational Medical Device collecting spectral Raman data from tissue

Timeline

• Start date: 2019-11-05
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-12-20
• Last updated: 2020-12-03

Locations

1 site across 1 country: Denmark