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

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Sanofi
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01184014
First received: August 16, 2010
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
 Drug: NPH insulin plus Complete Insulin Orders
Drug: Complete Insulin Orders
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • the proportion of blood glucose readings between 70 and 180 mg/dL, inclusive [ Time Frame: discharge or until after their 5th day in the hospital ] [ Designated as safety issue: No ]
    as stated above


Secondary Outcome Measures:
  • the mean blood glucose of all blood glucose 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 ] [ Designated as safety issue: No ]
    as stated above


Enrollment: 103
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
a study-specific steroid NPH dosing algorithm plus standard recommended care
 Drug: NPH insulin plus Complete Insulin Orders
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
Active Comparator: Control group
the standard recommended care (Methodist Hospital Complete Insulin Orders)
 Drug: Complete Insulin Orders
3-part insulin which includes background, meal-time and correction factor
Other Names:
  • lantus
  • glargine
  • humalog
  • lispro

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 <30mL/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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184014

Locations
United States, Minnesota
Park Nicollet Health Services Methodist Hospital
St. Louis Park, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
International Diabetes Center at Park Nicollet
Sanofi
Investigators
Principal Investigator: Richard M Bergenstal, MD International Diabetes Center at Park Nicollet
  More Information

Publications:

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01184014     History of Changes
Other Study ID Numbers: 04000-10-C
Study First Received: August 16, 2010
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
corticosteroid
hyperglycemia
hospital
corticosteroid induced hyperglycemia in the hospital

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
 Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013