Status:
COMPLETED
Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Sanofi
Conditions:
Type 2 Diabetes
Hyperglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if the early initiation of a long acting insulin (i.e. glargine) with supplemental doses of short acting regular (SSR) insulin in hospitalized patients with d...
Detailed Description
Hyperglycemia is one of the most frequently encountered complications of enteral nutrition therapy in the hospital setting. However, there is no standardized approach directed towards the identificati...
Eligibility Criteria
Inclusion
- Type 2 Diabetes defined according to ADA criteria
- Enteral nutrition therapy
- Two blood glucose readings \> 130 mg/dl within 48-hrs prior to or within a 48-hour period during enteral nutrition therapy
- Men and women age \>/= 18
- Ability for patient or legally authorized representative to understand and sign an informed consent document
Exclusion
- Subjects with conditions that are anticipated to have short term (i.e. \< 2 months survival) based on discussions with the treatment team and attending physician.
- Subjects admitted to the CT ICU or any unit with pre-established protocols for glycemic management.
- Subjects with known type 1 diabetes (who will absolutely require a long or intermediate acting insulin preparation).
- Subjects with known type 2 diabetes who currently receive 30 units or more of an intermediate or long acting insulin.
- Pregnancy
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00177398
Start Date
February 1 2005
End Date
August 1 2006
Last Update
December 19 2007
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213