continuous glucose monitoring in the perioperative period improves glycaemic control in patients with diabetes
ID
Bron
Verkorte titel
Aandoening
diabetes mellitus
perioperative period
continuous glucose sensor
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Objective:
1. Does CGM improve glycaemic control in the perioperative period?
Doel van het onderzoek
continuous glucose monitoring in the perioperative period improves glycaemic control in patients with diabetes
Onderzoeksopzet
trial starts day of surgery
end of sensor period: three days after surgery
assessment of postoperative complications: 30 days after surgery
Onderzoeksproduct en/of interventie
use of continuous glucose sensor in the perioperative period
Publiek
Jorinde Polderman
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+205669111 pager 57431
j.a.polderman@amc.uva.nl
Wetenschappelijk
Jorinde Polderman
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+205669111 pager 57431
j.a.polderman@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
- Allergy for heparin
- Known HIT
- Total pancreatectomy
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL4764 |
NTR-old | NTR5009 |
Ander register | NL48359.018.14 : 2014_266 |