Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site… (NCT06638567) | Clinical Trial Compass
RecruitingNot Applicable
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Netherlands1,008 participantsStarted 2025-01-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.