Tight Glycemic Control by Artificial Pancreas

April 8, 2008 updated by: Kochi University

Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kohasu-Okocho
      • Nankoku-City, Kohasu-Okocho, Japan, 783-8505
        • Kochi Medical School, Kochi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • STG-22; NIKKISO Corporation, Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
the first postoperative 18 hours in the surgical intensive care unit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
the first postoperative 18 hours in the surgical intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (ESTIMATE)

April 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2008

Last Update Submitted That Met QC Criteria

April 8, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGC-AP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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