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Performance Study of a Non-invasive Glucose Monitoring Device Prototype

Diabetes Mellitus Clinical Trial

Official title:
Performance Study of a Non-invasive Glucose Monitoring Device Prototype

Clinical Trial Summary

This clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in private homes of subjects.

Clinical Trial Description

Protocol consists of two parts:

Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03519841
Study type Interventional
Source RSP Systems A/S
Contact
Status Completed
Phase N/A
Start date April 13, 2018
Completion date October 8, 2018
View Details
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