Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device

Diabetes Mellitus Clinical Trial

Official title:

Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352518
• Other study ID #: RSP-12-02
• Status: Completed
• Phase: N/A
• Start date: December 28, 2017
• Est. completion date: April 17, 2018

Study information

• Verified date: November 2017
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Description:

Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 17, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects 18 years of age or older

• Diabetic patients (all types)

Exclusion Criteria:

• Pregnant women

• Subjects not able to understand and read Danish

• In investigator's opinion, subject is not able to follow instructions as specified in the protocol

• Subjects not able to hold hand/arm steadily

• Extensive skin changes, tattoos or diseases on probe application site

• Known allergy to medical grade alcohol used to disinfect skin

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• WM3.4NR
The investigational medical device will collect spectral raman data from tissue.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology M, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation and validation of predictive calibration models	The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.	3 months
Secondary	Safety assessment of the intervention by the paucity of adverse events	The number of subjects experiencing device-related adverse events will be recorded.	3 months