Tight Glycemic Control by Artificial Pancreas
Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
1 other identifier
interventional
32
1 country
1
Brief Summary
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedApril 14, 2008
April 1, 2008
8 months
April 4, 2008
April 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
the first postoperative 18 hours in the surgical intensive care unit
Secondary Outcomes (1)
the total amount of insulin required for glycemic control after pancreatic resection
the first postoperative 18 hours in the surgical intensive care unit
Study Arms (1)
2
EXPERIMENTALThirty 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.
Interventions
Eligibility Criteria
You may qualify if:
- This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kochi Universitylead
Study Sites (1)
Kochi Medical School, Kochi University
Nankoku, Kohasu-Okocho, 783-8505, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Takehiro Okabayashi, MD
Kochi Medical School, Kochi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 14, 2008
Study Start
April 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 14, 2008
Record last verified: 2008-04