|- candidate number||21171|
|- NTR Number||NTR5009|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-dec-2014|
|- Secondary IDs||2014_266 NL48359.018.14 |
|- Public Title||COMPAS studie|
|- Scientific Title||the effect of continuous glucose monitoring in patients with diabetes undergoing major surgery|
|- hypothesis||continuous glucose monitoring in the perioperative period improves glycaemic control in patients with diabetes|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus, Pre-operative, Continuous glucose sensor|
|- Inclusion criteria||- Aged 18-85 |
- Able to give written informed consent
- Laparotomy or cardiac surgery with planned postoperative stay at PACU or Will receive an arterial line for standard patient care
|- Exclusion criteria||- Any condition that the local investigator feels would interfere with trial participation or the evaluation of results|
- Allergy for heparin
- Known HIT
- Total pancreatectomy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||29-mei-2015|
|- Target number of participants||36|
|- Interventions||use of continuous glucose sensor in the perioperative period|
|- Primary outcome||The difference in median glucose 1 hour after surgery will be calculated as a measure of glycaemic control during surgery.
Furthermore, the difference in proportion of time spent in the target range, time spent above the target range and time spent below the target range between groups will be calculated.
|- Secondary outcome||The secondary outcome measure include the accuracy of the GCM, measured by the mean absolute relative difference (MARD= (CGM value−POC/POC)). |
Furthermore a 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 hour18. The difference in occurrence of postoperative complications will be assessed according to Dindo-Clavien grading system19 30 days after surgery.
|- Timepoints||trial starts day of surgery|
end of sensor period: three days after surgery
assessment of postoperative complications: 30 days after surgery
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Jorinde Polderman|
|- CONTACT for SCIENTIFIC QUERIES||MD, MA, DEAA B. Preckel|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: 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 reduce postoperative complications. Our objectives are to evaluate whether CGM improves glycaemic control.
1. Does CGM improve glycaemic control in the perioperative period?
|- Main changes (audit trail)|
|- RECORD||17-dec-2014 - 22-mei-2015|