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Recruiting NCT06638567

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

Trial Parameters

Condition Diabetes Mellitus, Type 2
Sponsor Abraham Hulst, MD, PhD
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,008
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-03
Completion 2027-02
Interventions
Basal bolus insulin regimen

Brief 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.

Eligibility 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.

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