Performance Study of a Non-invasive Glucose Monitoring Device Prototype

NCT ID: NCT03519841

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2018-10-08

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

Protocol consists of two parts:

Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

RSP-13-01

Experimental: IMD data collection Subjects will intensively collect spectral Raman data on P0.1 in a home-based setting for 5 days. Data will be paired with reference measurements.

Group Type: EXPERIMENTAL

P0.1

Intervention Type: DEVICE

Investigational Medical Device collecting spectral Raman data from tissue.

RSP-13-02

Experimental: IMD data collection Subjects will collect spectral Raman data on P0.1 during four measuring sessions a day for 30 days distributed over a time period of 60 days. Each timepoint is conducted in duplicate. Spectral data will be compared to standard BG measurements.

Group Type: EXPERIMENTAL

P0.1

Intervention Type: DEVICE

Investigational Medical Device collecting spectral Raman data from tissue.

Interventions

P0.1

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), insulin requiring
• 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
• Rejection by optical screenings
• 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-13-01
• Systemic or topical administration of glucocorticoids for the past 7 days
• Subjects 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, PhD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Odense, Denmark

Vibe Vestergaard, Nurse

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Odense, Denmark

Locations

Steno Diabetes Center Odense

Odense, , Denmark

Countries

Denmark

Other Identifiers

RSP-13

Identifier Type: -

Identifier Source: org_study_id