Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Diabetes Clinical Trial

Official title:

Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021251
• Other study ID #: RSP-16
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: August 2021

Study information

• Verified date: August 2020
• Source: RSP Systems A/S
• Contact: Stefan Ovesen Banke, MSc
• Phone: +45 71 99 79 77
• Email: stefan[@]rspsystems.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• P0.2
Investigational Medical Device collecting spectral raman data from tissue.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology M	Odense

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of predictive algorithms for determining blood glucose levels	Collected spectral raman data will found the development of predictive algorithms for glucose determination.	3 years
Primary	Validation of predictive algorithms for determining blood glucose levels	Performance of predictive models will be evaluated using the consensus error grid.	3 years