NCT03368209

Noninvasive Glucose Measurements - Database and Calibration Compilation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: RSP Systems A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.

Detailed description

This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	WM3.4	Investigational Medical Device collecting spectral raman data from tissue.

Timeline

• Start date: 2015-12-04
• Primary completion: 2017-05-07
• Completion: 2017-05-07
• First posted: 2017-12-11
• Last updated: 2020-10-08

Locations

1 site across 1 country: Denmark