Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
- Conditions
- Hyperglycemia
- Interventions
- Drug: NPH insulin plus Complete Insulin OrdersDrug: Complete Insulin Orders
- Registration Number
- NCT01184014
- Lead Sponsor
- HealthPartners Institute
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group NPH insulin plus Complete Insulin Orders a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO). Control group Complete Insulin Orders the standard recommended care (Methodist Hospital Complete Insulin Orders)
- Primary Outcome Measures
Name Time Method Mean Blood Glucose of All Readings 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Park Nicollet Health Services Methodist Hospital
🇺🇸Saint Louis Park, Minnesota, United States