Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
NCT ID: NCT03352518
Last Updated: 2018-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2017-12-28
2018-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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IMD data collection
Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators.
WM3.4NR
The investigational medical device will collect spectral raman data from tissue.
Interventions
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WM3.4NR
The investigational medical device will collect spectral raman data from tissue.
Eligibility Criteria
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Inclusion Criteria
* Diabetic patients (all types)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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RSP Systems A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Erik Henriksen, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Odense
Locations
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Department of Endocrinology M, Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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RSP-12-02
Identifier Type: -
Identifier Source: org_study_id
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