Our objectives are to evaluate whether CGM improves perioperative glycaemic control.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference in median glucose 1 hour after
surgery, as a measure of glycaemic control during surgery.
Furthermore, the time spent in the target range, time spent above the target
range and time spent below the target range will be calculated.
Secondary outcome
Secondary outcome measures include the accuracy of the GCM, measured by the
mean absolute relative difference (MARD= (CGM value*POC/POC)). Furthermore,
Clarke error grid and Bland-Altman analyses, MARD in the lower glycaemic
(glucose < 5 mmol/l), euglycaemic (glucose between 5 and 10 mmol/l) and
hyperglycaemic (glucose >10 mmol/l) ranges. The ranges are according to the
AMC protocol. The MARD during cardiopulmonary bypass and during the use of
vasopressors will also be calculated. We will record the number of false
alarms, the number of times the intravenous line has to be replaced due to
failure of the device or clotting error.
Also, the glucose variability, the amount of insulin used and the occurrence
hypoglycaemic events (glucose < 4.0 mmol/l) and severe hypoglycaemia (glucose
<2.3 mmol/l) will be compared between groups. Glucose variability will be
expressed as mean absolute glucose change (MAG) per hour17. The difference in
occurrence of postoperative complications will be assessed 30 days after
surgery.
Background summary
Although hyperglycaemia in patients with diabetes mellitus (DM) is associated
with complications after surgery, the frequency of glucose measurements in the
perioperative period (during and after surgery) is notoriously low. In the
general surgical population with DM, a postoperative glucose reduction of 1
mmol/l significantly decreases the occurrence of postoperative complications,
implicating the necessity of glucose monitoring in the perioperative period.
Over the past decade, several continuous glucose monitors (CGM) have been
tested in the perioperative phase, but none has been deemed accurate enough
without the need for placing a central venous line.
If we can accurately monitor glucose continuously during the perioperative
period, this might improve glycaemic control, and thereby possibly reducing
postoperative complications.
Study objective
Our objectives are to evaluate whether CGM improves perioperative glycaemic
control.
Study design
This is an investigator-initiated randomized controlled trial. After informed
consent, patients will be randomized on the day of surgery into two groups; the
Standard Care (SC) arm and the Continuous Glucose (CG) arm.
* SC arm: the screen of the CGM (Edwards, GlucoClear) will be turned off during
the perioperative period, but the glucose values will be registered. During the
whole perioperative period, glucose is measured according to standard care: the
AMC protocol (appendix 1) with a POC blood gas analyser (Siemens RAPIDlab 1265)
and these values are used for guiding treatment. On the ward, glucose is
measured and treated according to standard care. The CGM will be removed on day
2 after surgery. The POC values will be matched with the corresponding CGM
values afterwards.
* CG arm: perioperative, a continuous glucose value will be visible on the
screen and will guide treatment. When a perioperative value of the CGM is
outside the target range, this will be double checked with the POC blood gas
analyser. When glucose is below < 4 mmol/l, the POC value will be used to guide
treatment. When glucose is > 10 mmol/l and the deviation is < 1 mmol/l we will
use the GCM to guide teatment. If the deviation is > 1 mmol/l we will use the
POC value to guide treatment. In addition, in these patients glucose will be
measured every 60-120 min during surgery with a POC blood gas analyser as a
safety check. Postoperatively, only POC blood gas samples taken for standard
care (every 60-120 min) will be matched with the values of the CGM. At 08.00
hr on day 1 postoperative, the screen of the CGM will be turned off. On the
ward, glucose is measured and treated according to standard care. The CGM will
be removed on day 3 after surgery. The POC values will be matched with the
corresponding CGM value afterwards.
Thirty days postoperatively, the occurrence of postoperative complications will
be established in all patients by a short telephone interview.
Study burden and risks
Potential risks
The only additional risk involved with this study is a thrombopheblitis in the
vein where the monitoring device is inserted. This risk is small en easily
treated.
Potential benefits
Glucose will be intensively monitored during surgery, which could improve the
glucose regulation and decrease the risk of hypoglycaemia during surgery.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged 18-85
- Diagnosed with diabetes mellitus
- Able to give written informed consent
- Planned for laparotomy or cardiac surgery
- Will receive arterial line for standard patient care
- Planned postoperative stay at PACU or ICU
Exclusion criteria
- Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
- Allergy for heparin
- Known heparin induced thrombocytopenia
- Planned total panceatectomy
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 | NL48359.018.14 |