Tight Glycemic Control by Artificial Pancreas
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial|
- the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas [ Time Frame: the first postoperative 18 hours in the surgical intensive care unit ] [ Designated as safety issue: Yes ]
- the total amount of insulin required for glycemic control after pancreatic resection [ Time Frame: the first postoperative 18 hours in the surgical intensive care unit ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Thirty patients who underwent pancreatic resection for pancreatic neoplasm were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method or the artificial pancreas.
Device: Artificial Pancreas (STG-22)
Other Name: STG-22; NIKKISO Corporation, Japan
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657995
|Kochi Medical School, Kochi University|
|Nankoku-City, Kohasu-Okocho, Japan, 783-8505|
|Study Director:||Takehiro Okabayashi, MD||Kochi Medical School, Kochi University|