- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021251
Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
August 13, 2020 updated by: RSP Systems A/S
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects
Study Overview
Detailed Description
Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines.
Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Odense, Denmark, 5000
- Recruiting
- Department of Endocrinology M
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Contact:
- Jan Erik Henriksen, MD
- Phone Number: +45 65411811
- Email: Jan.Erik.Henriksen@rsyd.dk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects 18 years of age or older
- Diabetic patients (all types)
- Skin phototype 1-4
Exclusion Criteria:
- For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- For female participants: Breastfeeding
- Subjects not able to understand and read Danish
- In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
- Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Diagnosed with reduced circulation
- Extensive skin changes, tattoos or diseases on probe application site
- Known allergy to medical grade alcohol
- Known allergy to adhesives, applicable to subjects in RSP-16-01
- Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
- Participants undergoing dialysis treatment
- Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
- Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
- Participants currently enrolled in another study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Short term collection of IMD data
Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days.
Spectral data will be compared to standard BG and/or FGM measurements.
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Investigational Medical Device collecting spectral raman data from tissue.
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Experimental: Medium term collection of IMD data
Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days.
Spectral data will be compared to standard BG measurements.
|
Investigational Medical Device collecting spectral raman data from tissue.
|
Experimental: Long term collection of IMD data
Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months.
Spectral data will be compared to standard BG measurements.
|
Investigational Medical Device collecting spectral raman data from tissue.
|
Experimental: Medium term collection of IMD data, increased # of sessions
Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days.
Spectral data will be compared to standard BG measurements.
The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm.
|
Investigational Medical Device collecting spectral raman data from tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generation of predictive algorithms for determining blood glucose levels
Time Frame: 3 years
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Collected spectral raman data will found the development of predictive algorithms for glucose determination.
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3 years
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Validation of predictive algorithms for determining blood glucose levels
Time Frame: 3 years
|
Performance of predictive models will be evaluated using the consensus error grid.
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Erik Henriksen, MD, Odense University Hospital, Dpt. of Endocrinology M
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2018
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
December 20, 2018
First Submitted That Met QC Criteria
July 15, 2019
First Posted (Actual)
July 16, 2019
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- RSP-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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