Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings
Tracking Information | |||||
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First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | December 13, 2007 | ||||
Start Date ICMJE | February 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00177398 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings | ||||
Official Title ICMJE | The Effect of Insulin Glargine on Glycemic Control, Morbidity, and Length of Stay in Hospitalized Subjects With Diabetes Receiving Enteral Nutrition | ||||
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 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. |
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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 identification and management of patients who develop hyperglycemia while receiving enteral nutrition. The primary aim of the study is to determine if the early initiation of subcutaneous glargine insulin with supplemental doses of sliding scale human regular (SSR) insulin in hospitalized subjects with diabetes receiving enteral nutrition reduces the frequency of hyperglycemia and hypoglycemia when compared to use of SSR insulin alone. In this proposal, we plan to investigate a strategy of early insulin therapy in the management of hospitalized subjects with diabetes mellitus who develop hyperglycemia defined as two blood glucose (BG) measurements greater than 130 mg/dl within 48 hours prior to or within a 48 hour period during enteral nutrition therapy. The study is a phase IV, investigator initiated randomized, parallel group clinical trial. Potential subjects will include those subjects with written orders for initiation of enteral feedings using a formula containing carbohydrates. Consented subjects will have bedside glucose monitoring performed every 6 hours for the first 48 hours following initiation of enteral nutrition to determine if hyperglycemia occurs. To determine a difference in mean plasma glucose of 25 mg/dl and hospital LOS of 4 days between the two groups with an of 0.01 with power of 0.9, 25 subjects will be randomized to each group (total of 50 subjects). Baseline and outcome variables between the two groups will be compared using Student's t-testing, chi-square analysis, and the Mann-Whitney U test. Group 1 will receiving a single daily dose of glargine insulin along with sliding scale regular human (SSR) insulin titrated according to blood glucose results. Group 2 will receive only sliding scale human regular (SSR) insulin titrated according to an algorithm. Both groups will be followed daily until enteral feedings are discontinued or for a maximum of three weeks. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Glargine insulin vs regular insulin | ||||
Study Arm (s) | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 50 | ||||
Completion Date | August 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00177398 | ||||
Other Study ID Numbers ICMJE | IRB0408186 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | University of Pittsburgh | ||||
Collaborators ICMJE | Sanofi-Aventis | ||||
Investigators ICMJE |
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Information Provided By | University of Pittsburgh | ||||
Verification Date | December 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |