- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00657995
Tight Glycemic Control by Artificial Pancreas
April 8, 2008 updated by: Kochi University
Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kohasu-Okocho
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Nankoku-City, Kohasu-Okocho, Japan, 783-8505
- Kochi Medical School, Kochi University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 2
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.
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safe tool
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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the first postoperative 18 hours in the surgical intensive care unit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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the first postoperative 18 hours in the surgical intensive care unit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
April 4, 2008
First Submitted That Met QC Criteria
April 8, 2008
First Posted (ESTIMATE)
April 14, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
April 14, 2008
Last Update Submitted That Met QC Criteria
April 8, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TGC-AP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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