NCT06638567Recruiting
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.
Source: ClinicalTrials.gov · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1008 (estimated)
- First submitted
- 10 Mar 2024
- Start date
- 3 Jan 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Abraham Hulst, MD, PhD
- Diseases
- Type 2 diabetes
- NCT number
- NCT06638567
What you commit to
- Study type: Interventional
- Planned participants: 1008
- From 3 Jan 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergoing bariatric surgery
Other illness
- Diagnosed with type 1 diabetes mellitus
Other
- Female of child-bearing potential who is pregnant or breastfeeding.
- Undergoing complete pancreatectomy
- Patients using a continuous insulin pump at home
- Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.