Tight Glycemic Control by Artificial Pancreas

Pancreatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657995
• Other study ID #: TGC-AP-01
• Status: Completed
• Phase: N/A
• First received: April 4, 2008
• Last updated: April 8, 2008
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2008
• Source: Kochi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Device:
• Artificial Pancreas (STG-22)
safe tool

Locations

Country	Name	City	State
Japan	Kochi Medical School, Kochi University	Nankoku-City	Kohasu-Okocho

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas		the first postoperative 18 hours in the surgical intensive care unit	Yes
Secondary	the total amount of insulin required for glycemic control after pancreatic resection		the first postoperative 18 hours in the surgical intensive care unit	Yes