Database and Calibration of a Non-invasive Glucose Monitoring Device

NCT03362528 | Completed

• 1 other identifier: RSP-10
• Study Type: interventional
• Target: 12
• 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 (1)

• Generation and validation of predictive algorithms for determining blood glucose levels

  Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid

  7 months

Study Arms (2)

Short term collection of IMD data

EXPERIMENTAL

Subjects will collect spectral raman data on WM3.4NR four times a day for 30 days distributed over a time period of 60 days. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.

Device: WM3.4NR

Long term collection of IMD data

EXPERIMENTAL

Subjects will collect spectral raman data on WM3.4NR four times a day for the initial 30 days, distributed over a time period of 60 days. Subjects will for the remaining 60 days of measurements, distributed over 120 days collect spectral data twice a day. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.

Device: WM3.4NR

Interventions

WM3.4NR DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Long term collection of IMD data; 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 (all types) patients

You may not qualify if:

• Pregnant women
• Subjects not able to understand and read Danish
• In investigator's opinion, subject is not able to follow instructions as specified in the protocol
• Subjects not able to hold hand/arm steadily
• Extensive skin changes, tattoos or diseases on probe application site
• Rejection by prescreening optical measurements
• Known allergy to medical grade alcohol used to disinfect skin

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Department of Endocrinology M

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

  Odense University Hospital, Dpt. of Endocrinology M

  PRINCIPAL INVESTIGATOR

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: November 20, 2017
• First Posted: December 5, 2017
• Study Start: September 25, 2017
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)