Database and Calibration of a Non-invasive Glucose Monitoring Device

NCT ID: NCT03362528

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2019-01-28

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

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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

WM3.4NR

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

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.

Group Type: EXPERIMENTAL

WM3.4NR

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Interventions

WM3.4NR

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 (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

• 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

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital, Dpt. of Endocrinology M

Locations

Department of Endocrinology M

Odense, , Denmark

Countries

Denmark

Other Identifiers

RSP-10

Identifier Type: -

Identifier Source: org_study_id