Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: P0.5

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edgbaston
    • Birmingham, Edgbaston, United Kingdom, B15 2TH
      • Centre for Rare Disease ITM, Heritage Building (Queen Elizabeth Hospital Birmingham)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement accuracy of IMD	Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD).	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation: paucity of adverse events	Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study.	8 months

Collaborators and Investigators

• Sponsor: RSP Systems A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Non-invasive glucose monitoring
• Other Study ID Numbers: RSP 18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No