Database and Calibration of a Non-invasive Glucose Monitoring Device

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: WM3.4NR

• Registration Number: NCT03362528
• Lead Sponsor: RSP Systems A/S

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.

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-05
• Primary Completion: 2019-01-28
• Study Completion: 2019-01-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short term collection of IMD data	WM3.4NR	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.
Long term collection of IMD data	WM3.4NR	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.

Primary Outcome Measures

Name	Time	Method
Generation and validation of predictive algorithms for determining blood glucose levels	7 months	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

Trial Locations

Locations (1)

Department of Endocrinology M; 🇩🇰 Odense, Denmark