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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28417
Enrollment
30
Registered
2015-08-06
Start date
2015-08-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus glucose measurements validation of glucose measurement technique

Interventions

The current proposal has to be seen as a preliminary set of measurements, aimed at examining the reliability of the Freestyle-Libre.

Sponsors

Drs M.J.Fokkert department of Clinical Chemistry Isala Clinics P.O.Box 10,400 8000GK Zwolle m.j.fokkert@isala.nl
Lead Sponsor

Eligibility

Inclusion criteria

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 Able to perform general daily activities

Exclusion criteria

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. Chronic use of high doses of paracetamol and / or vitamin C

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactH.J.G. Bilo

internist Universitair Medisch Centrum Groningen Hanzeplein 1, 9713 GZ Groningen Afdeling Interne Geneeskunde Hoofd Diabetes Kenniscentrum Zwolle Postbus 10400, 8000 GK Dokter van Heesweg 2, 8025 AB Zwolle

h.j.g.bilo@isala.nl038-4242518

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)