Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06638567

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

Led by Abraham Hulst, MD, PhD · Updated on 2025-01-30

1008

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

Sponsors

A

Abraham Hulst, MD, PhD

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 or older
  • Diagnosed with type 2 diabetes mellitus
  • Undergoing gastrointestinal or vascular surgery
  • Admitted to one of the participating surgical wards
  • Expected to stay at least one night in the hospital
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed with type 1 diabetes mellitus
  • Female of child-bearing potential who is pregnant or breastfeeding
  • Undergoing complete pancreatectomy
  • Undergoing bariatric surgery
  • Using a continuous insulin pump at home
  • Undergoing necrotectomy or wound debridement from a pre-existing wound

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

A

Ayla Y. Stobbe, MD

CONTACT

S

Sarah E. Siegelaar, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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