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Tight Glycemic Control by Artificial Pancreas

This study has been completed.
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00657995
First received: April 4, 2008
Last updated: April 8, 2008
Last verified: April 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657995

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

No publications provided

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:
pancreatogenic
diabetes
artificial
pancreas

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

ClinicalTrials.gov processed this record on May 16, 2013