Database and Calibration of a Non-invasive Glucose Monitoring Device

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: WM3.4NR

Detailed Description

Subjects will collect 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Department of Endocrinology M

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects 18 years of age or older
• Diabetic (all types) patients

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short term collection of IMD data; 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; Investigational Medical Device collecting spectral raman data from tissue.
Experimental: Long term collection of IMD data; 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; Investigational Medical Device collecting spectral raman data from tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RSP Systems A/S
• Investigators: Principal Investigator: Jan Erik Henriksen, MD, Odense University Hospital, Dpt. of Endocrinology M

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): January 28, 2019
• Study Completion (Actual): January 28, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RSP-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No