Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbraham Hulst, MD, PhD
About this trial
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.
Eligibility criteria
Qualifiers
Patients aged 18 or older
Diagnosed with type 2 diabetes mellitus
Undergoing gastointestinal or vascular surgery
Admitted to one of the participating surgical wards
Disqualifiers
Diagnosed with type 1 diabetes mellitus
Female of child-bearing potential who is pregnant or breastfeeding.
Undergoing complete pancreatectomy
Undergoing bariatric surgery
Trial design
Treatments tested in this trial
- Basal bolus insulin regimen
Treatment groups
1,008 Participants
are divided into 2 treatment groupsSponsors and collaborators
Abraham Hulst, MD, PhD
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov