Database and Calibration of a Non-invasive Glucose Monitoring Device

Diabetes Clinical Trial

Official title:

Database and Calibration of a Non-invasive Glucose Monitoring Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362528
• Other study ID #: RSP-10
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: January 28, 2019

Study information

• Verified date: December 2019
• 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 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• 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 (all types) patients

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

• Rejection by prescreening optical measurements

• Known allergy to medical grade alcohol used to disinfect skin

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• WM3.4NR
Investigational Medical Device collecting spectral raman data from tissue.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology M	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 algorithms for determining blood glucose levels	Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid	7 months