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Postoperative Insulin Infusion Omission After Pancreatectomy NCT07540975

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Summary

NIH registered clinical trial NCT07540975 on ClinicalTrials.gov. The randomized non-inferiority trial evaluates whether routine postoperative insulin infusion can be safely omitted in non-diabetic adults undergoing pancreatectomy for periampullary or pancreatic tumors. The primary endpoint is mean blood glucose levels through postoperative day 3.

“Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion?”

NIH , verbatim from source
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What changed

NIH has registered clinical trial NCT07540975, a randomized non-inferiority trial comparing standard postoperative insulin infusion against no routine insulin infusion in non-diabetic adults undergoing pancreatectomy for periampullary or pancreatic tumors. Participants will undergo blood glucose monitoring via intermittent testing and continuous flash glucose monitoring, with protocol-based rescue insulin for hyperglycemia or discontinuation for hypoglycemia.

Healthcare providers, clinical investigators, and pharmaceutical companies involved in perioperative insulin management should note this trial's formal registration. The trial aims to determine whether omitting routine insulin infusion provides comparable glycemic control while reducing treatment burden and adverse events, including surgical site infections within 3 months.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

N/A NCT07540975 Kind: NA Apr 21, 2026

Abstract

The goal of this randomized non-inferiority clinical trial is to evaluate whether routine postoperative insulin infusion can be safely omitted in preoperative non-diabetic adult patients undergoing pancreatectomy for periampullary or pancreatic tumors. The primary purpose is to determine whether withholding insulin infusion provides comparable glycemic control while reducing treatment-related burden and adverse events.

The main questions it aims to answer are:

  • Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion?
  • Does omission of insulin infusion reduce the incidence of hypoglycemia without increasing postoperative complications, including surgical site infection within 3 months?

Researchers will compare a no-insulin infusion group (intervention arm) with a standard insulin infusion group (control arm) to determine whether avoiding routine insulin infusion maintains comparable glycemic control while improving safety and patient comfort.

Participants will:

  • Undergo pancreatectomy and be randomly assigned (1:1) to either receive standard insulin infusion or no routine insulin infusion postoperatively
  • Have blood glucose monitored using intermittent testing and continuous glucose monitoring (flash glucose monitoring system)
  • Receive protocol-based glycemic management, including rescue insulin if hyperglycemia occurs or discontinuation if hypoglycemia...

Conditions: Postoperative Hyperglycemia, Pancreatectomy

Interventions: Insulin Infusion, No Insulin Infusion (Standard Monitoring Only)

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07540975

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trials Insulin therapy Glycemic monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Medical Devices

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