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

Diabete Mellitus Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03781232
Study type Interventional
Source RSP Systems A/S
Contact
Status Completed
Phase N/A
Start date November 22, 2018
Completion date August 5, 2019
View Details
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