Comparing insulin regimens to reduce surgical site infections in diabetes patients
Official title: Postoperative Glucose Control with a Basal Bolus Versus Sliding Scale Insulin Regimen and Its Effect on the Incidence of Surgical Site Infections in People with Type 2 Diabetes Mellitus.
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06638567 · Data updated 2026-11-12
This study is testing if a new way of giving insulin can help reduce the risk of infections after surgery for people with type 2 diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1008 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | January 3, 2025 |
| Main results expected | February 2027 |
| Study ends | September 2027 |
| Registry record updated | January 30, 2025 |
| Trial ID | NCT06638567 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older with type 2 diabetes mellitus who are scheduled for gastrointestinal or vascular surgery.
✕Probably not a fit
Patients with type 1 diabetes, those undergoing specific surgeries like complete pancreatectomy or bariatric surgery, and individuals using continuous insulin pumps may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicentre trial investigates the effectiveness of a proactive basal bolus insulin regimen versus a reactive sliding scale insulin regimen in reducing surgical site infections (SSI) in adult patients with type 2 diabetes undergoing gastrointestinal or vascular surgery. Participants will be monitored with a blind continuous glucose monitor (CGM) from admission until discharge, and insulin dosages will be adjusted based on glucose levels. The study aims to enroll 1008 participants across 18 wards in 8 centers, with wards matched by baseline SSI rates to ensure robust comparisons. Participants will also complete questionnaires 30 days post-surgery to assess outcomes.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of surgical site infections in patients with type 2 diabetes, improving postoperative recovery and outcomes.
How similar studies have gone: Previous studies have shown that proactive insulin management can reduce postoperative complications, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Amsterdam UMC
Amsterdam, Netherlands Recruiting
Study contacts
- Principal investigator: Sarah E. Siegelaar, MD, PhD — Amsterdam UMC, location AMC
- Study coordinator: Ayla Y. Stobbe, MD
- Email: a.y.stobbe@amsterdamumc.nl
- Phone: 0031205669111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.