To compare the efficiency and safety of Continuous subcutaneous glucose monitoring compared to our standard care (bloodsamples obtained from an arterial or venous bloodsample and measured by the AccuChek.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Number of severe hypoglycemia and severe hyperglycemia
Definitions:
- Hypoglycemia: glucose level< 2,5 mmol/l
- Severe hyperglycemia: glucss > 25 mmol/l
Secondary outcome
- Amount of time in which the patient blood glucose levels are in the blood
glucose target range ( measured with the Freestyle Navigator)
- Amount of time in which the patient blood glucose levels are above or beneath
the blood glucose target range. ( measured with the Freestyle Navigator)
- Variability of the glucose regulation measured with the blood gas analyser.
(use of arterial bloodsamples) Expressed as mean Absolute Glucose change per
hour (MAG).
- Length of stay on the ICU
- Mortality
- False positive alarms of the Freestyle Navigator
- Number of unwanted low glucose every 24 hours ( glucose between 2.5 - 5.0
mmol)
- Number of not detected hypoglycemia by the AccuChek. ( measured with the
Freestyle Navigator)
- Number of obtained bloodsamples per day per patient
Background summary
Strict glucose regulation is part of the standard IC treatement since the Van
den Berghe-studies in 2001 and 2006 showed an improved outcome for critically
ill patients with strict glucose regulation (blood glucose between 4 and 6
mmol/l) . However, in other multicenter trials and a recent meta-analysis,
benefit of strict glucose regulation was not found. Moreover, strict glycaemic
control increases the risk of hypoglycaemia (NICE-SUGAR trial). Another study
found that intensive glucose control increased mortality among adults in the
Intensive Care Unit. This could be caused by hypoglycaemia. These days it is
common to use a higher blood glucose target in critically ill adults.
Strict glucose regulation is performed at the ICU of the OLVG. Therefore we
implemented a computerized guideline for glucose regulation of critically ill
patients. We measure glucose levels with frequent arterial blood samples which
are analyzed by point of care measurement (AccuChek.)
Nowadays a continuous subcutaneous glucose monitoring (CGM),which is also
applicable and reliable for crititically ill patients, is available.
Advantages if continuous glucoes measuremnt in IC patients may be:
- cost reduction
- better knowledge of glucose levels in critically ill patients
- early detection of hypglycemia
- less blood samples required
- less tasks for the IC nurses
Study objective
To compare the efficiency and safety of Continuous subcutaneous glucose
monitoring compared to our standard care (bloodsamples obtained from an
arterial or venous bloodsample and measured by the AccuChek.
Study design
Critically ill patients admitted on the intensive care unit of the Onze Lieve
Vrouwengasthuis with a minimum age of 18 years. Patients which are applicable
to the activation of our ICU glucose protocol (see appendix 2 of the
studyprotocol pg 14) and gave informed consent will be included in our study.
Intervention
The continuous glucose measurement (CGM) device (Freestyle navigator) will be
inserted in both study groups. We will only use the results of the intervention
group. The results of the control group will be blinded.
The FreeStyle Navigator® CGM system (Abbott Diabetes Care, Alameda, CA) is a
miniature electrochemical sensor placed in the subcutaneous adipose tissue and
transmits data through radiofrequency to receiver, which also displays
continuous glucose values. Glucose is measured in the interstitial fluid . The
size of the freestyle Navigator is a few cm2.
Calibration is required 5 times during the study: after 1 hour, 2 hours, 8 a 10
hours, 24 a 32 hours and 72 a 80 hours.
The Freestyle Navigator will start to measure after the first callibration.
Before this time the Accu Chek will be used.
Every four hours, glucose in both groups is measured with an arterial blood gas
analyzer. (ABL800 flex, Radiometer Copenhagen)
Intervention group: The glucose level measured with the Freestyle Navigator wil
be inserted in the computerized protocol for glucose regulation .
Control group: The glucose level measured with the standard method (Accu Chek)
will be inserted in the computerized protocol for glucose regulation.
The sensor lasts a maximum of 5 days. After these 5 days the study will be
finished. The subcutaneous sensor will be removed.
Study burden and risks
The risk for paticipants is judged to be minor. The insertion and wearing of
the sensors is minimally invasive. The Freestyle Navigator is a miniature
electrochemical sensor placed in the subcutaneous adipose tissue. The sensor is
about 2 cm2. The sensor will be attached to the skin with a plaster.
The sensor will last for a maximum of 5 days.The Freestyle will stop measuring
after 5 days. This will be the end of the study. The subcutaneous sensor will
be removed.
In total a maximum of 20 arterial or venous bloodsamles of 1.5 ml will be
obtained besides standard care samples. The bloodsamples will be obtained from
an intra arterial or intravenous catheter. Insertion of these catheters are
standard care on the ICU.The arterial line is routinely in situ for routine
blood sampling and continuous monitoring of blood pressure.
Oosterpark 9
1091 AC Amsterdam
NL
Oosterpark 9
1091 AC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
-ICU patients of 18 years and older
-Expected length of stay longer than 24 hours
-Indication for glucose regulation with insuline. (see appendix study protocol)
- Availability of the Freestyle Nagivator
Exclusion criteria
Participation in another WMO study
- No informed consent
- Contra indication for the use of the AccuChek: (peritoneal dialysis, Hematocrit< 0,20 or > 0,65 , paracetamol intoxication)
- Abdominal abnormalities that inhibit sensor insertion
- Participation of the same study in an earlier ICU admittance.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL33495.100.10 |