Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

Study Overview
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Brief Summary
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The objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.

Detailed Description
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The overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. This study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (BG) >180 mg/dL): 1) a study-specific steroid NPH dosing algorithm plus standard recommended care (Experimental group) vs. 2) the standard recommended care (Methodist Hospital Complete Insulin Orders (Control group).

Official Title
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Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

Conditions
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Hyperglycemia

Intervention / Treatment
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* Drug: NPH insulin plus Complete Insulin Orders
* Drug: Complete Insulin Orders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged ≥18 years who receive steroids in doses greater than physiologic replacement levels of ≥ 10 mg Prednisone or its equivalent of dexamethasone or methylprednisolone. Have signed the consent form for the study Have a BG > 180 mg/dL any time during the first 24 hour of steroid administration that is above physiological replacement ( ≥ 10 mg Prednisone or equivalent) Are scheduled to be in hospital ≥ 2 days. Exclusion Criteria: Unable to read or understand English History of psychiatric disability affecting informed consent or compliance with drug intake Type 1 diabetes Acute or chronic renal failure (creatinine clearance < 30 mL/min estimated by method of Cockcroft and Gault) Patients in Hospice Care Age <18 years Previously enrolled in this study. Not appropriate for the steroid protocol in judgment of the principal investigator and/or attending physician.

Ages Eligible for Study
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Minimum Age: 18 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: Experimental group<br>a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO). | Drug: NPH insulin plus Complete Insulin Orders<br>* NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor.<br>* Other names: lispro;|
| Active Comparator: Control group<br>the standard recommended care (Methodist Hospital Complete Insulin Orders) | Drug: Complete Insulin Orders<br>* 3-part insulin which includes background, meal-time and correction factor<br>* Other names: lispro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Glucose of All Readings | Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days | starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticosteroid, hyperglycemia, hospital, corticosteroid induced hyperglycemia in the hospital