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Tight Glycemic Control by Artificial Pancreas

Not Applicable
Completed
Conditions
Pancreatic Neoplasm
Interventions
Device: Artificial Pancreas (STG-22)
Registration Number
NCT00657995
Lead Sponsor
Kochi University
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
2Artificial Pancreas (STG-22)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.
Primary Outcome Measures
NameTimeMethod
the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreasthe first postoperative 18 hours in the surgical intensive care unit
Secondary Outcome Measures
NameTimeMethod
the total amount of insulin required for glycemic control after pancreatic resectionthe first postoperative 18 hours in the surgical intensive care unit

Trial Locations

Locations (1)

Kochi Medical School, Kochi University

🇯🇵

Nankoku-City, Kohasu-Okocho, Japan

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