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OpenTrials
Completed

NCT Number: NCT00657995

Tight Glycemic Control by Artificial Pancreas

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

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Key information

Conditions

Pancreatic Neoplasm Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kochi Medical School, Kochi University

Nankoku, Kohasu-Okocho, 783-8505, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial Pancreas (STG-22)

Device

safe tool

Other names: STG-22; NIKKISO Corporation, Japan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 14, 2008
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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