Tight Glycemic Control by Artificial Pancreas

This study has been completed.
Information provided by:
Kochi University
ClinicalTrials.gov 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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.

Genders Eligible for Study:   Both
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 ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT00657995     History of Changes
Other Study ID Numbers: TGC-AP-01 
Study First Received: April 4, 2008
Last Updated: April 8, 2008
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016