Overview

Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
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 diabetes who are fed using tube feedings reduces the frequency of high and low blood sugar levels when compared to use of SSR insulin alone.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Sanofi
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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