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

Plain Language Summary

Simplified for easier understanding

This study compares two insulin regimens for people with Type 2 diabetes who are having gastrointestinal or vascular surgery: a structured basal-bolus regimen (a combination of long-acting and mealtime insulin) versus a sliding-scale regimen (insulin given only when blood sugar is too high). Researchers want to see which approach better prevents post-surgery wound infections. **You may be eligible if...** - You are 18 or older with Type 2 diabetes - You are having gastrointestinal or vascular surgery - You will be staying overnight in the hospital after surgery - You are willing and able to give informed consent **You may NOT be eligible if...** - You have Type 1 diabetes - You are pregnant or breastfeeding - You are having a total pancreatectomy or bariatric (weight loss) surgery - You currently use a continuous insulin pump at home - You are having a wound debridement (cleaning) for an existing wound Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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