Primary Objective of the study: the agreement of the Free Style Libre Measurement with the laboratorium measurement and the AccuChekSecundary Objective: Delay of the interstitial glucose versus the Blood glucose measurements during an operation…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of agreement between the measurements of the Free Style libre
monitor eand the blood glucose measured by the laboratorium.
Secondary outcome
Time delay between the changes in the blood glucose and the interstitium
measured by the laboratory measurements and teh Free Style Libre Method.
Background summary
In subjects with diabetes mellitus, adequate to good metabolic control is
necessary for a variety of reasons. In subjects under general anesthesia,
adequate glucose control, including prevention of hypo- and hyperglycemias,
improves surgical outcomes.
One variation on earlier continue glucose monitoring (CGM) is FreeStyle Libre
Flash Monitor (FLFM) an improved easiness of use and practical applicability.
Relying on a CGM device implicates the assumption, that the device will be
accurate and reliable.
For assessment of the accuracy and reliability the FLFM, under conditions of
general anesthesia, it is proposed to perform a comparison of this device with
a standard laboratory measurement during surgery under general anesthesia in
patients.
In an earlier study (unpublished data) Bilo et al. had to conclude that during
extreme exercise FLFM does show higher than actually present glucose levels (as
assessed by capillary measurements). Bilo et al. hypothesized that increases in
interstitial fluid flow contribute to reporting higher glucose concentrations
compared to result with lower interstitial fluid flow in resting circumstances.
Our hypothesis is that an operation under general anesthesia is a stressful
event and can be compared with exercise; however, due to supine position of the
patient and no muscle activity, blood flow and thus fluid refreshment of the
interstitium will be decreased. Therefore, we hypothesize that FLFM will
probably measure lower glucose concentration than peripheral measured blood
glucose concentrations
Study objective
Primary Objective of the study: the agreement of the Free Style Libre
Measurement with the laboratorium measurement and the AccuChek
Secundary Objective: Delay of the interstitial glucose versus the Blood glucose
measurements during an operation under general anesthesia.
Study design
Fifteen patients who will be operated under general anesthesia for more than
one hour. The patients have to receive an arterial catheter because of their
operation or because of their health
Study burden and risks
A short needle will be brought under the skin. this needle had to be at their
place 36 hours before the operation till the end of the operation.
No further risks are involved.
Dr. van Heesweg 2
8011 JW Zwolle 8025AB
NL
Dr. van Heesweg 2
8011 JW Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
Patients under general anesthsia.
Operation time > 1 hour
Exclusion criteria
no informed consent
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 | NL68465.075.18 |