NCT06638567 Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
| NCT ID | NCT06638567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abraham Hulst, MD, PhD |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,008 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,008 participants in total. It began in 2025-01-03 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Sarah E. Siegelaar, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT06638567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06638567 currently recruiting?
Yes, NCT06638567 is actively recruiting participants. Contact the research team at a.y.stobbe@amsterdamumc.nl for enrollment information.
Where is the NCT06638567 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06638567 clinical trial?
NCT06638567 is sponsored by Abraham Hulst, MD, PhD. The principal investigator is Sarah E. Siegelaar, MD, PhD at Amsterdam UMC, location AMC. The trial plans to enroll 1,008 participants.
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