Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Recruiting · NCT06638567 · Interventional (participants receive a specific treatment) · Lead sponsor: Abraham Hulst, MD, PhD
View the official record on ClinicalTrials.gov →Interventions studied
Basal bolus insulin regimen
What this trial is about
A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients aged 18 or older
- Diagnosed with type 2 diabetes mellitus
- Undergoing gastointestinal or vascular surgery
- Admitted to one of the participating surgical wards
- Expected duration of stay at least one overnight stay
- Willing and able to provide informed consent
Exclusion criteria
- Diagnosed with type 1 diabetes mellitus
- Female of child-bearing potential who is pregnant or breastfeeding.
- Undergoing complete pancreatectomy
- Undergoing bariatric surgery
- Patients using a continuous insulin pump at home
- Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.
Where it is running
1 location listed.
- Amsterdam UMC - Amsterdam, Netherlands