Validation Freestyle continuous registration of glucose for the purpose of safe and correct use in the Netherlands
- Conditions
- diabetes mellitusglucose measurementsvalidation of glucose measurement technique
- Registration Number
- NL-OMON28417
- Lead Sponsor
- Drs M.J.Fokkertdepartment of Clinical ChemistryIsala ClinicsP.O.Box 10,4008000GK Zwollem.j.fokkert@isala.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
10 non-DM, 10 T1DM, 10 T2DM in a stable situation
Able to undergo the required controls and to fill in the questionnaires proposed
Exclusion Criteria
Unable to understand the study information or the Dutch language
A condition that makes the health situation unstable or which results in the short term to serious
deterioration or death.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validate the Abbott Freestyle-Libre glucose measurement technique used on various insertion sites, by comparing its outcomes with another continuous glucose monitoring (CGM) technique and laboratory testing as the golden standard for glucose measurement.
- Secondary Outcome Measures
Name Time Method 1. Comparing the use of the Freestyle Libre between insertion in the upper arm and abdominal insertion (currently the Freestyle Libre is only tested after insertion into the upper arm, comparative data on other places where this device can be inserted are missing) 2. Study the glucose values after eating a meal using the Freestyle Libre and venous measurements (meal clamp technique) 3. Study the influence of the use of paracetamol and vitamin C on the reliability of the Freestyle libre results.