Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device

Not Applicable

Completed

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

• Registration Number: NCT03352518
• 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 spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2017-12-28
• Primary Completion: 2018-04-13
• Study Completion: 2018-04-17
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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
• Known allergy to medical grade alcohol used to disinfect skin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMD data collection	WM3.4NR	Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators.

Primary Outcome Measures

Name	Time	Method
Generation and validation of predictive calibration models	3 months	The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.

Secondary Outcome Measures

Name	Time	Method
Safety assessment of the intervention by the paucity of adverse events	3 months	The number of subjects experiencing device-related adverse events will be recorded.

Trial Locations

Locations (1)

Department of Endocrinology M, Odense University Hospital; 🇩🇰 Odense, Denmark