We hypothesise that using a continuous subcutaneous glucose monitor during pancreatic surgery, will significantly improve percentage of time spent in glycaemic target range (i.e. glucose ≥ 4 mmol/l and < 10 mmol/l).
ID
Source
Brief title
Health condition
Pancreatic disease, diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of time spent in glycaemic target range (i.e. glucose ≥ 4 mmol/l and < 10 mmol/l).
Secondary outcome
Secondary outcomes include QoR-40,9 postoperative complications after 30 days and incidence of DM de novo.
Background summary
Pancreatic surgery often results in impaired glucose metabolism or diabetes mellitus, depending on the endocrine function of the residual pancreatic parenchyma. Poor perioperative glycaemic control has been associated with unfavourable outcome after surgery. Therefore, patients undergoing pancreatic surgery may substantially benefit from improved glucose monitoring. In this study we will assess the efficacy of continuous glucose monitoring for perioperative glucose control in patients undergoing pancreatic surgery.
Study objective
We hypothesise that using a continuous subcutaneous glucose monitor during pancreatic surgery, will significantly improve percentage of time spent in glycaemic target range (i.e. glucose ≥ 4 mmol/l and < 10 mmol/l).
Study design
Glucose will be measured by both the sensor and according to standard of care (POCT analyser) during the intraoperative and early postoperative period (day +1). On day + 30, follow-up by telephone or email is scheduled, after which trial participation ends.
Intervention
Patients will receive a subcutaneous glucose sensor on the day before surgery. The glucose values measured will be used to guide treatment during the intraoperative and early postoperative period. Glucose measurements will be confirmed using a point-of-care analyser.
Inclusion criteria
Adult patients, aged between 18 and 85, undergoing either pancreaticoduodenectomy or distal pancreatectomy, willing and able to provide written informed consent.
Exclusion criteria
Unable to communicate in Dutch or English, psychiatric disorder or any other condition the local investigator feels would interfere with trial participation or measurements
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8055 |
| CCMO | NL70513.018.19 |