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2007-04
2007-12
2007-12
32
NCT00657995
Kochi University
Kochi University
INTERVENTIONAL
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.
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2008-04-04 | N/A | 2008-04-08 |
2008-04-08 | N/A | 2008-04-14 |
2008-04-14 | N/A | 2008-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 | DEVICE: Artificial Pancreas (STG-22)
|
| Primary Outcome Measures | Measure Description | 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 | the first postoperative 18 hours in the surgical intensive care unit |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| the total amount of insulin required for glycemic control after pancreatic resection | the first postoperative 18 hours in the surgical intensive care unit |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
