Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin

NCT04060693 | Withdrawn

• 1 other identifier: RSP 18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety evaluation: paucity of adverse events

  8 months

Study Arms (1)

Protocol 1

EXPERIMENTAL

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

Interventions

P0.5 DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Protocol 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Centre for Rare Disease ITM, Heritage Building (Queen Elizabeth Hospital Birmingham)

Birmingham, Edgbaston, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open, non-randomized comparison study between device and blood references with diabetic patients.

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: August 19, 2019
• Study Start: December 10, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)