A Phase 4 interventional study of Glargine insulin vs regular insulin in Type 2 Diabetes and Hyperglycemia, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-19.
Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
The primary outcome to be studied is the frequency and severity of hyperglycemia and hypoglycemia in each group
Time to mean 24 hour plasma glucose < 180 mg/dl
Triglyceride level at study entry and conclusion
Hospital length of stay
Inpatient mortality
Number of days of antibiotic therapy
Number of days with recorded temperature >/= 100.4F
Occurrence of any of the following: MI, CHF, pneumonia, CVA, renal impairment (defined as serum creat > 2 mg/dl)
Quality of Life measures using MOS SF 36 General Health Survey
Outpatient glycemic control and self management practices
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh