NCT03781232

Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes

Non-invasive Glucose Measurement With Raman Technology. Calibration of Newly Developed Devices in Patients With Type 1 and Type 2 Diabetes - Glucobrunn Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: RSP Systems A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3

Detailed description

Subjects are recruited at two different sites. Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement sessions a day. A measurement session consist of a reference capillary blood sample and two measures on the IMD. Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days. During the home measurements, 6 measurement sessions will be performed by the subjects a day. A measurement session consists of two reference BGMs, two reference CGMs and two measurements on the device. On in-clinic visits, subjects will be administered high glucose breakfast and the following 6-7 hours, measurement sessions are performed every 15 minutes.

Conditions

• Diabete Mellitus
• Medical Device

Interventions

Type	Name	Description
DEVICE	Prototype 0.3	Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy

Timeline

• Start date: 2018-11-22
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2018-12-19
• Last updated: 2019-12-04

Locations

2 sites across 1 country: Germany