The primary objective of this study is to determine the point accuracy of a microdialysis*based continuous glucose monitoring system. Secondary objectives include trend accuracy and reliability of the system.
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The main study parameter is point accuracy of continuous glucose monitoring*
measurements as compared to current arterial blood glucose measurements.
Secondary outcome
Other study parameters include trend accuracy and reliability of the system.
Background summary
Insulin infusion in critically ill patients mandates frequent measurements of
the blood glucose level. Several systems for continuous glucose monitoring have
been developed, including systems that use microdialysis. Microdialysis is a
well*established technology that offers the opportunity to sample blood
analytes with high accuracy but without drawing any blood.
Study objective
The primary objective of this study is to determine the point accuracy of a
microdialysis*based continuous glucose monitoring system. Secondary objectives
include trend accuracy and reliability of the system.
Study design
This study concerns an investigator*initiated observational study in
consecutive critically ill patients subjected to routine care*insulin infusion
adjusted to reach blood glucose levels between 90 and 144 mg/dL (i.e., between
5 and 8 mmol/L).
Study burden and risks
The system has been tested and validated in a number of pre*clinical studies in
non*ICU patients, and has been found to be safe and accurate in the non*ICU
setting. The device uses a special central venous catheter, which reduces the
need for another central venous lines (i.e., the specialized central venous
catheter replaces the normally*used intravenous catheter). Patients
participating in this study are subjected to extra blood draws to a maximum of
up to 12 ml in three days (i.e., a maximum of up to 4 ml per day), which is
considered acceptable and safe. Patients could benefit from the study since
continuous glucose monitoring could improve titration of insulin, in particular
by preventing insulin*induced hypoglycemia.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
At least 18 years old;
Arterial catheter needed for standard care and present;
Central venous catheter needed for standard care;
Admitted to the ICU; and
Expected to stay in the ICU for at least 48 hours.
Exclusion criteria
Currently participating in another investigational drug or device study
Known pregnancy.
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 | NL47628.018.14 |
Other | volgt |