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Tight Glycemic Control by Artificial Pancreas

This study has been completed.
Information provided by:
Kochi University Identifier:
First received: April 4, 2008
Last updated: April 8, 2008
Last verified: April 2008
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Condition Intervention
Pancreatic Neoplasm
Device: Artificial Pancreas (STG-22)

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by Kochi University:

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 [ Time Frame: the first postoperative 18 hours in the surgical intensive care unit ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Artificial Pancreas (STG-22)
safe tool
Other Name: STG-22; NIKKISO Corporation, Japan

Detailed Description:
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00657995

Kochi Medical School, Kochi University
Nankoku-City, Kohasu-Okocho, Japan, 783-8505
Sponsors and Collaborators
Kochi University
Study Director: Takehiro Okabayashi, MD Kochi Medical School, Kochi University
  More Information

Responsible Party: Kochi Medical School/Department of Surgery, Kochi University Identifier: NCT00657995     History of Changes
Other Study ID Numbers: TGC-AP-01
Study First Received: April 4, 2008
Last Updated: April 8, 2008

Keywords provided by Kochi University:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents processed this record on April 26, 2017