Tight Glycemic Control by Artificial Pancreas
Information source: Kochi University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Neoplasm
Intervention: Artificial Pancreas (STG-22) (Device)
Phase: N/A
Status: Completed
Sponsored by: Kochi University Official(s) and/or principal investigator(s):
Takehiro Okabayashi, MD, Study Director, Affiliation: Kochi Medical School, Kochi University
Summary
This study evaluated a closed-loop system providing continuous monitoring and strict control
of perioperative blood glucose following pancreatic resection.
Clinical Details
Official title: Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
Secondary outcome: the total amount of insulin required for glycemic control after pancreatic resection
Detailed description:
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic
disease.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- This study recruited 32 patients undergoing elective pancreatic resection for
pancreatic disease.
Exclusion Criteria:
- weight loss greater than 10% during the previous 6 months
- signs of distant metastasis
- respiratory, renal,or heart disease
- Patients provided written informed consent prior to enrollment
Locations and Contacts
Kochi Medical School, Kochi University, Nankoku-City, Kohasu-Okocho 783-8505, Japan
Additional Information
Starting date: April 2007
Ending date: December 2007
Last updated: April 8, 2008
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