Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

NCT ID: NCT04021251

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2021-08-31

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

Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Short term collection of IMD data

Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days. Spectral data will be compared to standard BG and/or FGM measurements.

Group Type: EXPERIMENTAL

P0.2

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Medium term collection of IMD data

Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements.

Group Type: EXPERIMENTAL

P0.2

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Long term collection of IMD data

Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months. Spectral data will be compared to standard BG measurements.

Group Type: EXPERIMENTAL

P0.2

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Medium term collection of IMD data, increased # of sessions

Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm.

Group Type: EXPERIMENTAL

P0.2

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Interventions

P0.2

Investigational Medical Device collecting spectral raman data from tissue.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male and female subjects 18 years of age or older
• Diabetic patients (all types)
• Skin phototype 1-4

Exclusion Criteria

• For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
• For female participants: Breastfeeding
• Subjects not able to understand and read Danish
• In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
• Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
• Diagnosed with reduced circulation
• Extensive skin changes, tattoos or diseases on probe application site
• Known allergy to medical grade alcohol
• Known allergy to adhesives, applicable to subjects in RSP-16-01
• Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
• Participants undergoing dialysis treatment
• Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
• Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
• Participants currently enrolled in another study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RSP Systems A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Erik Henriksen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital, Dpt. of Endocrinology M

Locations

Department of Endocrinology M

Odense, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Stefan Ovesen Banke, MSc

Role: CONTACT

stefan@rspsystems.com

+45 71 99 79 77

Facility Contacts

Jan Erik Henriksen, MD

Role: primary

Jan.Erik.Henriksen@rsyd.dk

+45 65411811

Other Identifiers

RSP-16

Identifier Type: -

Identifier Source: org_study_id