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Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin

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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Recruitment Status : Withdrawn (Miscommunication with the CRO that was hired to help with the regulatory submission process)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

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE August 19, 2019
Last Update Posted Date October 8, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Official Title  ICMJE Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Brief Summary This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Device: P0.5
Investigational Medical Device collecting spectral raman data from tissue.
Study Arms  ICMJE 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.
Intervention: Device: P0.5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 6, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2019)
15
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04060693
Other Study ID Numbers  ICMJE RSP 18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RSP Systems A/S
Study Sponsor  ICMJE RSP Systems A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RSP Systems A/S
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP