RecruitingNot ApplicableNCT06638567

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

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.


Sponsor

Abraham Hulst, MD, PhD

Enrollment

1,008 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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.

Interventions

OTHERBasal bolus insulin regimen

Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively


Locations(1)

Amsterdam UMC

Amsterdam, Netherlands

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NCT06638567


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