Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

Study Overview
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Brief Summary
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The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design. Note: Lantus insulin is the proprietary name for glargine insulin.

Detailed Description
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Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart. Subjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows: Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion; Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion; Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion. The glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.

Official Title
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Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

Conditions
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Hyperglycemia, Diabetes

Intervention / Treatment
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* Drug: insulin glargine
* Drug: insulin glargine
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting glucose > 100 mg/dl Patients on surgical services or in intensive care units receiving intravenous insulin Exclusion Criteria: Inability to obtain informed consent from patient or next-of-kin Allergy to insulin Participation in another research study Patients for whom there are do-not-resuscitate orders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40% Glargine<br>Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate. | Drug: insulin glargine<br>* Insulin glargine given at 40% of prior stable drip rate.<br>* Other names: Lantus is brand name for Glargine;|
| Experimental: 60% Glargine<br>Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate. | Drug: insulin glargine<br>* Insulin glargine given at 60% of prior stable drip rate.<br>* Other names: Lantus is brand name for Glargine;|
| Experimental: 80% Glargine<br>Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate. | Drug: insulin glargine<br>* Insulin glargine given at 80% of prior stable drip rate.<br>* Other names: Lantus is brand name for Glargine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Blood Glucose Values Between 80 - 140 | Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL | First 24 hours after conversion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Glucose Values < 50 mg/dL | Percentage of blood glucose values < 50 mg/dL | First 24 hours after conversion | 
| Percentage of Glucose Levels > 180 mg/dL | Percentage of blood glucose levels > 180 mg/dL | First 24 hours after conversion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin, glargine, intravenous, subcutaneous, hospital, diabetes, glucose, inpatient