The GlucoPred Investigation II

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT02595580
• Date of registration: 02/11/2015
• Prospective Registration: Yes
• Primary sponsor: Norwegian University of Science and Technology
• Public title: The GlucoPred Investigation II GPI-II
• Scientific title: An Open, Controlled Investigation of Measurement Precision, System Accuracy and User Performance Evaluation in Subjects With Diabetes Mellitus Type 1 Using GlucoPred, a Non-invasive Continuous Blood Glucose Measurement Device
• Date of first enrolment: January 2016
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02595580
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Sven M Carlsen, md prof
• Affiliation: Norwegian University of Science and Technology

Key inclusion & exclusion criteria

Inclusion Criteria:

- diabetes mellitus type 1

- has read and understood the informed consent documentation and is willing to
participate in the investigation and willing to sign the informed consent form

- willing to participate in the investigation using one or two GlucoPred sensors for a
period of 8 days

- willing to attend 2 investigational visits with duration of up to 4 hours during the
investigational period

- willing to take and record up to 16 finger-stick blood samples on Day 1 and up to 8
finger-stick blood samples daily for measuring reference values for the duration of
the investigation

- Uses a blood-glucose monitoring system for self-testing on a daily basis

- Willing to use the provided blood-glucose monitoring system during the investigation

- Has access to and is willing to use a computer for downloading data and charging the
sensor

Exclusion Criteria:

- not fit for the investigation due concurrent illness

- Unfit for participation for any reason judged by the investigator

- pregnancy



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

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Device: Glucopred

Primary Outcome(s)

difference between Glucopred and the reference method [Time Frame: 8 days]

Secondary ID(s)

PM-GPI-II-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Olavs Hospital

Sykehuset Ostfold