Status:

COMPLETED

Database and Calibration of a Non-invasive Glucose Monitoring Device

Lead Sponsor:

RSP Systems A/S

Conditions:

Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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

Detailed 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 ...

Eligibility Criteria

Inclusion

  • Male and female subjects 18 years of age or older
  • Diabetic (all types) patients

Exclusion

  • 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

Key Trial Info

Start Date :

September 25 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 28 2019

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03362528

Start Date

September 25 2017

End Date

January 28 2019

Last Update

December 4 2019

Active Locations (1)

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Department of Endocrinology M

Odense, Denmark, 5000