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Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin

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: NCT04060693
Recruitment Status : Withdrawn (Miscommunication with the CRO that was hired to help with the regulatory submission process)
First Posted : August 19, 2019
Last Update Posted : October 8, 2020
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: P0.5 Not Applicable

Detailed Description:
The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a blood glucose meter (Contour Next One, Ascenia). Optical measurements are collected with the investigational medical device. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open, non-randomized comparison study between device and blood references with diabetic patients.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Protocol 1
The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a BG-meter (Contour Next One, Ascenia). Optical measurements are collected with the IMD. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a BG-meter and two IMD measurements. IMD measurements will be performed within 3 minutes after the BG measurement using the thenar of the right hand of the subject.
Device: P0.5
Investigational Medical Device collecting spectral raman data from tissue.




Primary Outcome Measures :
  1. Measurement accuracy of IMD [ Time Frame: 8 months ]
    Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD).


Secondary Outcome Measures :
  1. Safety evaluation: paucity of adverse events [ Time Frame: 8 months ]
    Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study.



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:

  • Between 18 and 40 years of age.
  • Have a diagnosis of diabetes mellitus.
  • Distribution of skin phototype: 50-70 % of enrolled subjects phototype IV, 20-40 % of enrolled subjects phototype III, 5-15 % of enrolled subjects phototype II, 5-15 % of enrolled subjects phototype I.
  • Be willing to perform a minimum of 8 finger sticks per day during the study.
  • Be willing to perform a minimum of 8 optical measurements per day during the study.
  • Be willing to provide written signed and dated informed consent.

Exclusion Criteria:

  • Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only).
  • Subjects not able to understand and read English.
  • Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
  • Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
  • Diagnosed with cardiovascular diseases.
  • Reduced circulation in right hand evaluated by Allen's test.
  • Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity.
  • Radiotherapy for the past six months.
  • Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
  • Known allergy to medical grade alcohol used to clean the skin.
  • Systemic or topical administration of glucocorticoids for the past 7 days and under investigation.
  • Subjects undergoing dialysis treatment.
  • Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
  • Medical history or any condition that may, in the opinion of the investigator, compromise subject's ability to participate.
  • Subjects 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): NCT04060693


Locations
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United Kingdom
Centre for Rare Disease ITM, Heritage Building (Queen Elizabeth Hospital Birmingham)
Birmingham, Edgbaston, United Kingdom, B15 2TH
Sponsors and Collaborators
RSP Systems A/S
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Responsible Party: RSP Systems A/S
ClinicalTrials.gov Identifier: NCT04060693    
Other Study ID Numbers: RSP 18
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
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
Keywords provided by RSP Systems A/S:
Non-invasive glucose monitoring