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Completed

NCT Number: NCT01184014

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

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.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Park Nicollet Health Services Methodist Hospital

Saint Louis Park, Minnesota, 55416, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NPH insulin plus Complete Insulin Orders

Drug

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.

Other names: lantus, glargine, humalog, lispro

Complete Insulin Orders

Drug

3-part insulin which includes background, meal-time and correction factor

Other names: lantus, glargine, humalog, lispro

Primary outcomes

  1. Mean Blood Glucose of All Readings

    Time frame: 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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • International Diabetes Center at Park Nicollet
  • Sanofi

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2010
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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