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Study Summary
No. 2007-0616:.......Endocrine......Naifa L. Busaidy......Endocrine Neoplasia & Hormonal Disorders
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Study Summary Title
Study Summary
Number:		2007-0616
Study Title:Continuous Glucose Monitoring device compared with Point-of-care Glucose testing in the ICU
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Physician New Patient Referral
Name:Naifa L. BusaidyPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Endocrine Neoplasia & Hormonal DisordersReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2841
Contact us about clinical trials
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General Information
Disease Group:EndocrineSupported By:Medtronic
University of Texas Health Systems
Phase of Study:N/AReturn
Visit:		We are only following these patients while they are in the ICU here at MDACC.
Treatment
Agents:		Guardian or continuous glucose monitorHome Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		Patients recruited to this study will be in the intensive care unit. We will
follow them throughout their hospital stay. We do not anticipate that this
device under investigation will prolong their ICU stay.
Description/
Intervention:		The goal of this clinical research study is to learn if The Guardian®
blood-sugar monitoring device can be used reliably in patients with high blood
sugar who are receiving care in the ICU. Researchers will compare blood-sugar
measurements from the study device with blood-sugar measurements from the
standard "fingerstick" method of blood-sugar testing. This is being done to
see if the new device can accurately measure blood sugar.
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Study Objectives / Outcomes
Primary:
1. To determine reliability of glucose monitoring device as compared with point of care / fingerstick glucose testing.

Secondary:
1. To determine what conditions, if any, where continuous glucose monitoring device may not be reliable.
2. To determine if the continuous glucose monitor provides more clinically important information for determining insulin infusion protocol changes as compared with point-of-care testing.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:01/11/2008
Study Type:Observational
Recruitment Status:Open
Projected Accrual:60
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients in any of our University of Texas collaborative intensive care units.

2) Critically ill patients on an insulin infusion protocol
Exclusion Criteria:1) Patients or their legal representatives who do not consent

2) Patients with large areas of skin affected so as not to allow implantation of device.

3) Patients < 18 years of age
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Links
Registration Number: NCT00707434
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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