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van CCT (UK)

van CCT (UK)

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

- candidate number22544
- NTR NumberNTR5348
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-aug-2015
- Secondary IDsABR number 51993 file number NL51993.075.14
- Public TitleValidation Freestyle continuous registration of glucose for the purpose of safe and correct use in the Netherlands
- Scientific TitleValidation Freestyle continuous registration of glucose for the purpose of safe and correct use in the Netherlands
- hypothesisIn people with diabetes mellitus, especially in people using insulin, regular monitoring of blood glucose levels is important. Usually, a finger prick is used. Such a finger prick is usually more painful than the insulin injection itself, and many people therefore do not check their glucose values as often as is needed. People with DM check themselves from several times a week upto more than ten times a day. In recent years, a continuous glucose registration became available. With a few minutes intervals, glucose is measured in the interstitial fluid. However, this equipment is expensive and the usage will therefore be limited. In addition, the fact remains that the result is a glucose value in the interstitial fluid, which is lower than in the bloodstream and changes in the glucose levels in the bloodstream take time to be monitored in the interstitial fluid (estimated to be about 20 to 30 minutes). Many people with DM and a fluctuating or poor regulation of their glucose levels would be helped with a system that measures frequently without automatic reading ability. Recently, Abbott presented the Freestyle Libre. The costs associated with the use of this form of registration are lower than those of conventional CGM. Although this seems a good solution for people with DM who, for whatever reason, need to check frequently their glucose levels, this measurement method has not yet been adequately validated. This makes it necessary to validate this potentially important and positive development.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Glucose monitoring
- Inclusion criteria10 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 criteriaUnable 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-aug-2015
- planned closingdate30-nov-2015
- Target number of participants30
- InterventionsThe current proposal has to be seen as a preliminary set of measurements, aimed at examining the reliability of the Freestyle-Libre.
- Primary outcomeValidate 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 outcome1. 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.
- Timepointsstart of study 15-08-2015
end of study 30-11-2015
- Trial web site
- status[default]
- Sponsor/Initiator Drs M.J.Fokkert
- Funding
(Source(s) of Monetary or Material Support)
Stichting Achmea Gezondheidszorg (SAG)
- Publications
- Brief summaryObjective of the study: 1. Clarity regarding validity and usability of the Freestyle Libre, including detailed results regarding the strengths and weaknesses associated with this new technique 2. Clear advice on follow-up projects related to long-term quality control 3. Clear advice on follow-up programs with respect to similar device already developed or to be developed by other compagnies
- Main changes (audit trail)
- RECORD6-aug-2015 - 25-aug-2015

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