ClinicalTrials.gov
ClinicalTrials.gov Menu

Performance Study of a Non-invasive Glucose Monitoring Device Prototype

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03519841
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
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 Mellitus Device: P0.1 Not Applicable

Detailed Description:

Protocol consists of two parts:

Part A) Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Part B) Subjects will collect 4 daily optical Raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days period.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized comparison study between device and blood references with diabetic patients
Masking: Single (Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Performance Study of a Non-invasive Glucose Monitoring Device Prototype
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : October 15, 2018

Arm Intervention/treatment
Experimental: RSP-13-01
Experimental: IMD data collection Subjects will intensively collect spectral Raman data in a home-based setting for 5 days using P0.1 and comparators
Device: P0.1
Investigational Medical Device collecting spectral Raman data from tissue.

Experimental: RSP-13-02
Experimental: IMD data collection Subjects will collect spectral Raman data on P0.1 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: P0.1
Investigational Medical Device collecting spectral Raman data from tissue.




Primary Outcome Measures :
  1. Generation and validation of predictive models by ISUP and MARD measures [ Time Frame: 6 months ]

    Optical glucose data will be collected together with paired reference values (BGM and FGM, Protocol 1 and BGM, Subprotocol 2).

    For subprotocol 1, measurements will be collected every 15 minutes for 10 hours á day for 5 days distributed over a period of 10 day.

    For subprotocol 2, four daily measurements will be collected while subject is maintaining normal routines. Data will be collected for 30 days distributed over a period of 60 days.

    Optical glucose readings will be masked to the subjects.

    Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using MARD and ISUP measures.



Secondary Outcome Measures :
  1. Safety evaluation: paucity of adverse events [ Time Frame: 6 months ]
    Safety will be evaluated in a descriptive manner by the paucity of adverse events



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.


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 patients (all types), insulin requiring
  • 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
  • Rejection by optical screenings
  • 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-13-01
  • Systemic or topical administration of glucocorticoids for the past 7 days
  • Subjects 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

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): NCT03519841


Contacts
Contact: Stefan Ovesen Banke, MSc +45 71 99 28 18 stefan@rspsystems.com

Locations
Denmark
Steno Diabetes Center Odense Recruiting
Odense, Denmark, 5000
Contact: Vibe Vestergaard, Nurse       vibe.vestergaard@rsyd.dk   
Sponsors and Collaborators
RSP Systems A/S
Investigators
Principal Investigator: Jan Erik Henriksen, MD, PhD Steno Diabetes Center Odense, Denmark
Principal Investigator: Vibe Vestergaard, Nurse Steno Diabetes Center Odense, Denmark

Responsible Party: RSP Systems A/S
ClinicalTrials.gov Identifier: NCT03519841     History of Changes
Other Study ID Numbers: RSP-13
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by RSP Systems A/S:
Non-invasive glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases