Actively Recruiting
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Led by Abraham Hulst, MD, PhD · Updated on 2025-01-30
1008
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
A
Abraham Hulst, MD, PhD
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or older
- Diagnosed with type 2 diabetes mellitus
- Undergoing gastrointestinal or vascular surgery
- Admitted to one of the participating surgical wards
- Expected to stay at least one night in the hospital
- Willing and able to provide informed consent
You will not qualify if you...
- Diagnosed with type 1 diabetes mellitus
- Female of child-bearing potential who is pregnant or breastfeeding
- Undergoing complete pancreatectomy
- Undergoing bariatric surgery
- Using a continuous insulin pump at home
- Undergoing necrotectomy or wound debridement from a pre-existing wound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
A
Ayla Y. Stobbe, MD
CONTACT
S
Sarah E. Siegelaar, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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