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Tight Glycemic Control by Artificial Pancreas

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ClinicalTrials.gov Identifier: NCT00657995
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
Sponsor:
Information provided by:
Kochi University

Brief Summary:
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Condition or disease Intervention/treatment
Pancreatic Neoplasm Device: Artificial Pancreas (STG-22)

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Device: Artificial Pancreas (STG-22)
safe tool
Other Name: STG-22; NIKKISO Corporation, Japan



Primary Outcome Measures :
  1. 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 :
  1. 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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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kochi Medical School/Department of Surgery, Kochi University
ClinicalTrials.gov Identifier: NCT00657995     History of Changes
Other Study ID Numbers: TGC-AP-01
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 2008

Keywords provided by Kochi University:
pancreatogenic
diabetes
artificial
pancreas

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