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.…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Validate the Abbott Freestyle-Libre glucose measurement technique used on
verious 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
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.
Background summary
In 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.
Study objective
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
Study design
The current proposal has to be seen as a preliminary set of measurements, aimed
at examining the reliability of the Freestyle-Libre.
Study burden and risks
There are no risks associated with participation in this study except for the
risk of local pain and hematoma, like with all other CGM devices
Dr. van Heesweg 2
Zwolle 8025AB
NL
Dr. van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51993.075.14 |