Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

NCT04021251 | Unknown

• 1 other identifier: RSP-16
• Study Type: interventional
• Target: 24
• 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

Outcome Measures

Primary Outcomes (2)

• Generation of predictive algorithms for determining blood glucose levels

  Collected spectral raman data will found the development of predictive algorithms for glucose determination.

  3 years

• Validation of predictive algorithms for determining blood glucose levels

  Performance of predictive models will be evaluated using the consensus error grid.

  3 years

Study Arms (4)

Short term collection of IMD data

EXPERIMENTAL

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.

Device: P0.2

Medium term collection of IMD data

EXPERIMENTAL

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.

Device: P0.2

Long term collection of IMD data

EXPERIMENTAL

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.

Device: P0.2

Medium term collection of IMD data, increased # of sessions

EXPERIMENTAL

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.

Device: P0.2

Interventions

P0.2 DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Long term collection of IMD data; Medium term collection of IMD data; Medium term collection of IMD data, increased # of sessions; Short term collection of IMD data

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Department of Endocrinology M

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Erik Henriksen, MD

  Odense University Hospital, Dpt. of Endocrinology M

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Ovesen Banke, MSc

CONTACT

+45 71 99 79 77; stefan@rspsystems.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: July 16, 2019
• Study Start: December 20, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)