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

Phase 4
Completed
Conditions
Hyperglycemia
Interventions
Drug: NPH insulin plus Complete Insulin Orders
Drug: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupNPH insulin plus Complete Insulin Ordersa study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).
Control groupComplete Insulin Ordersthe standard recommended care (Methodist Hospital Complete Insulin Orders)
Primary Outcome Measures
NameTimeMethod
Mean Blood Glucose of All Readingsstarting 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
NameTimeMethod

Trial Locations

Locations (1)

Park Nicollet Health Services Methodist Hospital

🇺🇸

Saint Louis Park, Minnesota, United States

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