Comparing insulin regimens to reduce surgical site infections in diabetes patients
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1008 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06638567 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with type 2 diabetes mellitus who are scheduled for gastrointestinal or vascular surgery.
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.
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 performed: Previous studies have shown that proactive insulin management can reduce postoperative complications, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Amsterdam
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.