RecruitingNot Applicable

Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.

Netherlands1,008 participantsStarted 2025-01-03

Plain-language summary

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 participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Surgical site infection

Timeframe: Until 30 days after surgery

Trial details

NCT IDNCT06638567

SponsorAbraham Hulst, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Ayla Y. Stobbe, MD

0031205669111 a.y.stobbe@amsterdamumc.nl

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials