Tight Glycemic Control by Artificial Pancreas

NCT ID: NCT00657995

Last Updated: 2008-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Pancreatic Neoplasm

Keywords

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pancreatogenic diabetes artificial pancreas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Artificial Pancreas (STG-22)

Intervention Type DEVICE

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Interventions

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Artificial Pancreas (STG-22)

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Intervention Type DEVICE

Other Intervention Names

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STG-22; NIKKISO Corporation, Japan

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Kochi University

Principal Investigators

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Takehiro Okabayashi, MD

Role: STUDY_DIRECTOR

Kochi Medical School, Kochi University

Locations

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Kochi Medical School, Kochi University

Nankoku, Kohasu-Okocho, Japan

Site Status

Countries

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Japan

Other Identifiers

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TGC-AP-01

Identifier Type: -

Identifier Source: org_study_id