Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177398
Status:
COMPLETED
Last Update Posted:
2007-12-19
First Post:
2005-09-12
Brief Title:
Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Effect of Insulin Glargine on Glycemic Control Morbidity and Length of Stay in Hospitalized Subjects With Diabetes Receiving Enteral Nutrition
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the early initiation of a long acting insulin ie 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
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 mgdl 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 mgdl and hospital LOS of 4 days between the two groups with an of 001 with power of 09 25 subjects will be randomized to each group total of 50 subjects Baseline and outcome variables between the two groups will be compared using Students 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
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 mgdl 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 mgdl and hospital LOS of 4 days between the two groups with an of 001 with power of 09 25 subjects will be randomized to each group total of 50 subjects Baseline and outcome variables between the two groups will be compared using Students 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None