The aim is to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to a widely used reactive sliding scale regimen. It is hypothesised that a proactive basal-bolus insulin regimen targeting glucose levels of 3.9-10…
ID
Source
Brief title
Condition
- Diabetic complications
- Infections - pathogen unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of surgical site infections (SSI) within 30 days after surgery,
defined by the Centers for Disease Control and prevention (CDC) criteria.
Secondary outcome
Other hospital-acquired infections, the length of hospital stay, readmission
rates at 30 days after surgery, days at home at 30 days after surgery (DAH30),
the time in glucose range (3.9-10 mmol/l), time below glucose range (<3.9
mmol/l) and time above glucose range (>10 mmol/l) measured with a blinded
continuous glucose monitor (CGM) during the stay in the hospital, adherence to
the protocol, health-related quality of life 30 days after surgery (EuroQoL
5D5L), postoperative disability scores 30 days after surgery (WHODAS 2.0) and
associated costs from a healthcare and societal perspective (costs per
prevented SSI and QALY's gained).
Background summary
People with type 2 diabetes mellitus (PWT2D) are at increased risk of
postoperative complications, especially surgical site infections (SSI). It
remains unclear whether improvement of in-hospital glucose control reduces the
risk of SSI in people with T2D.
Study objective
The aim is to reduce SSI in PWT2D by implementing a proactive basal-bolus
insulin regimen, compared to a widely used reactive sliding scale regimen. It
is hypothesised that a proactive basal-bolus insulin regimen targeting glucose
levels of 3.9-10 mmol/l will be superior to a reactive sliding scale regimen
targeting glucose levels of 3.9-10 mmol/l, leading to a reduction of 50% of
SSI*s within the first 30 days after surgery.
Study design
Investigator-initiated, multicentre, matched-pair, cluster-randomised,
controlled superiority trial.
Intervention
A postoperative basal-bolus insulin regimen (intervention) will be compared to
a sliding scale insulin regimen (control).
Study burden and risks
General trial-related burden:
Participants will receive a blind CGM, i.e. glucose data are masked for the
participants and study team, from admission to the ward until discharge from
the hospital. In addition, all participants are asked to complete several
questionnaires 30 days after surgery.
Intervention group-related burden:
Both regimens are currently used in clinical practice. Therefore, there is no
additional trial-related burden depending on the intervention group allocation.
Preliminary studies suggest a benefit of a basal bolus regimen. There is no
evidence for an increase of hypoglycaemic events in a basal bolus regimen,
compared to a sliding scale regimen. Participants will be monitored and insulin
dosage will be adjusted adequately to the measured glucose values by the
treatment team. While the risks are low, this trial has a favourable
risk-benefit profile for participants. The overall study will provide insight
into the effectiveness of glycaemic control on postoperative recovery, with the
potential to improve care for all people with diabetes type 2 undergoing
surgery.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. > 18 years old
2. Diagnosed with type 2 diabetes mellitus
3. Undergoing abdominal or vascular surgery
4. Admitted to one of the participating surgical wards
5. Expected duration of stay at least one overnight stay
6. Willing and able to provide informed consent and complete the questionnaires
Exclusion criteria
1. Diagnosed with type 1 diabetes mellitus
2. Female who is pregnant or breast-feeding.
3. Undergoing a total pancreatectomy or surgery that leads to total insulin
deficiency
4. Undergoing bariatric surgery
5. Patients using a continuous insulin pump at home
6. Patients undergoing a necrotectomy/wound debridement from a pre-existent
wound
Design
Recruitment
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 | NL86101.018.24 |
| Other | Volgt |