Performance Study of a Non-invasive Glucose Monitoring Device Prototype

NCT03519841 | Completed

• 1 other identifier: RSP-13
• Study Type: interventional
• Target: 6
• 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; Raman spectroscopy

Outcome Measures

Primary Outcomes (1)

• Generation and validation of predictive models by ISUP and MARD measures

  Optical glucose data will be collected together with paired reference values (BGM and FGM, Protocol 1 and BGM, Subprotocol 2). For subprotocol 1, measurements will be collected every 15 minutes for 10 hours a day for 5 days distributed over a period of 10 days. For subprotocol 2, four daily measurements will be collected while subject is maintaining normal routines. Data will be collected for 30 days distributed over a period of 60 days. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using MARD and ISUP measures.

  6 months

Secondary Outcomes (1)

• Safety evaluation: paucity of adverse events

  6 months

Study Arms (2)

RSP-13-01

EXPERIMENTAL

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.

Device: P0.1

RSP-13-02

EXPERIMENTAL

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.

Device: P0.1

Interventions

P0.1 DEVICE

Investigational Medical Device collecting spectral Raman data from tissue.

RSP-13-01; RSP-13-02

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), insulin requiring
• 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
• 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

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Steno Diabetes Center Odense

Odense, 5000, Denmark

Location

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, PhD

  Steno Diabetes Center Odense, Denmark

  PRINCIPAL INVESTIGATOR

• Vibe Vestergaard, Nurse

  Steno Diabetes Center Odense, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized interventional study comparing device and blood reference measurements in diabetic patients

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 9, 2018
• Study Start: April 13, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)