Database and Calibration of a Non-invasive Glucose Monitoring Device

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03362528
• Date of registration: 20/11/2017
• Prospective Registration: No
• Primary sponsor: RSP Systems A/S
• Public title: Database and Calibration of a Non-invasive Glucose Monitoring Device
• Scientific title: Database and Calibration of a Non-invasive Glucose Monitoring Device
• Date of first enrolment: September 25, 2017
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03362528
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Jan Erik Henriksen, MD
• Affiliation: Odense University Hospital, Dpt. of Endocrinology M

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Device: WM3.4NR

Primary Outcome(s)

Generation and validation of predictive algorithms for determining blood glucose levels [Time Frame: 7 months]

Secondary ID(s)

RSP-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors