Validation Freestyle continuous registration of glucose for the purpose of safe and correct use in the Netherlands

Phase 4

Completed

Conditions: Diabetes
10018424

Registration Number: NL-OMON42315

Lead Sponsor: Interne geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Age 18-75 jaar
10 non-DM, 10 T1DM, 10 T2DM in a stable situation
Able to undergo the required controls and to fill in the questionnaires proposed
Able to perform general daily activities

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.
Chrnisch gebruik van hoge doses paracetamol en / of vitamine C

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Validate the Abbott Freestyle-Libre glucose measurement technique used on<br /><br>verious insertion sites, by comparing its outcomes with another continuous<br /><br>glucose monitoring (CGM) technique and laboratory testing as the golden<br /><br>standard for glucose measurement.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Comparing the use of the Freestyle Libre between insertion in the upper arm<br /><br>and abdominal insertion (currently the Freestyle Libre is only tested after<br /><br>insertion into the upper arm, comparative data on other places where this<br /><br>device can be inserted are missing)<br /><br>2. Study the glucose values after eating a meal using the Freestyle Libre and<br /><br>venous measurements (meal clamp technique)<br /><br>3. Study the influence of the use of paracetamol and vitamin C on the<br /><br>reliability of the Freestyle libre results.</p><br>