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Recruitment Status : Withdrawn (Miscommunication with the CRO that was hired to help with the regulatory submission process)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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: P0.5||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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)|
|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|
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.
Investigational Medical Device collecting spectral raman data from tissue.
- 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).
- 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.
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
|Centre for Rare Disease ITM, Heritage Building (Queen Elizabeth Hospital Birmingham)|
|Birmingham, Edgbaston, United Kingdom, B15 2TH|