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Database and Calibration of a Non-invasive Glucose Monitoring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362528
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
RSP Systems A/S

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

Condition or disease Intervention/treatment Phase
Diabetes Device: WM3.4NR Not Applicable

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 a 60 days period or collect data for 90 days during 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Database and Calibration of a Non-invasive Glucose Monitoring Device
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : January 28, 2019

Arm Intervention/treatment
Experimental: Short term collection of IMD data
Subjects will collect spectral raman data on WM3.4NR four times a day for 30 days distributed over a time period of 60 days. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.
Device: WM3.4NR
Investigational Medical Device collecting spectral raman data from tissue.

Experimental: Long term collection of IMD data
Subjects will collect spectral raman data on WM3.4NR four times a day for the initial 30 days, distributed over a time period of 60 days. Subjects will for the remaining 60 days of measurements, distributed over 120 days collect spectral data twice a day. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.
Device: WM3.4NR
Investigational Medical Device collecting spectral raman data from tissue.




Primary Outcome Measures :
  1. Generation and validation of predictive algorithms for determining blood glucose levels [ Time Frame: 7 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362528


Locations
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Denmark
Department of Endocrinology M
Odense, Denmark, 5000
Sponsors and Collaborators
RSP Systems A/S
Investigators
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Principal Investigator: Jan Erik Henriksen, MD Odense University Hospital, Dpt. of Endocrinology M
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Responsible Party: RSP Systems A/S
ClinicalTrials.gov Identifier: NCT03362528    
Other Study ID Numbers: RSP-10
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No