Tight Glycemic Control by Artificial Pancreas - Full Text View

Sponsor:	Kochi University
Information provided by:	Kochi University
ClinicalTrials.gov Identifier:	NCT00657995

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:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase Ultrase

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
2: Experimental 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

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, Kohasu-Okocho
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 University ( Kochi Medical School/Department of Surgery )
Study ID Numbers:	TGC-AP-01
Study First Received:	April 4, 2008
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00657995 History of Changes
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
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Therapeutic Uses
Pancreatic Neoplasms

Gastrointestinal Agents
Endocrine System Diseases
Pancreatic Diseases
Pancrelipase
Pharmacologic Actions
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010