Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Not Applicable

• Conditions: Diabetes

• Registration Number: NCT04021251
• 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 either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-17
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male and female subjects 18 years of age or older
• Diabetic patients (all types)
• Skin phototype 1-4

Exclusion Criteria

• For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
• For female participants: Breastfeeding
• Subjects not able to understand and read Danish
• In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
• Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
• Diagnosed with reduced circulation
• Extensive skin changes, tattoos or diseases on probe application site
• Known allergy to medical grade alcohol
• Known allergy to adhesives, applicable to subjects in RSP-16-01
• Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
• Participants undergoing dialysis treatment
• Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
• Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
• Participants currently enrolled in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Validation of predictive algorithms for determining blood glucose levels	3 years	Performance of predictive models will be evaluated using the consensus error grid.
Generation of predictive algorithms for determining blood glucose levels	3 years	Collected spectral raman data will found the development of predictive algorithms for glucose determination.

Trial Locations

Locations (1)

Department of Endocrinology M; 🇩🇰 Odense, Denmark