Back to resultsTight Glycemic Control by Artificial Pancreas
Primary Purpose
Pancreatic Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Artificial Pancreas (STG-22)
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasm focused on measuring pancreatogenic, diabetes, artificial, pancreas
Eligibility 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
Sites / Locations
- Kochi Medical School, Kochi University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2
Arm Description
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.
Outcomes
Primary Outcome Measures
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 Measures
the total amount of insulin required for glycemic control after pancreatic resection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00657995
Brief Title
Tight Glycemic Control by Artificial Pancreas
Official Title
Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kochi University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
Detailed Description
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm
Keywords
pancreatogenic, diabetes, artificial, pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artificial Pancreas (STG-22)
Other Intervention Name(s)
STG-22; NIKKISO Corporation, Japan
Intervention Description
safe tool
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD
Organizational Affiliation
Kochi Medical School, Kochi University
Official's Role
Study Director
Facility Information:
Facility Name
Kochi Medical School, Kochi University
City
Nankoku-City
State/Province
Kohasu-Okocho
ZIP/Postal Code
783-8505
Country
Japan
12. IPD Sharing Statement
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Tight Glycemic Control by Artificial Pancreas
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