Back to resultsHospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NPH insulin plus Complete Insulin Orders
Complete Insulin Orders
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring corticosteroid, hyperglycemia, hospital, corticosteroid induced hyperglycemia in the hospital
Eligibility 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 < 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.
Sites / Locations
- Park Nicollet Health Services Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).
the standard recommended care (Methodist Hospital Complete Insulin Orders)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01184014
First Posted
August 16, 2010
Last Updated
May 15, 2018
Sponsor
HealthPartners Institute
Collaborators
International Diabetes Center at Park Nicollet, Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01184014
Brief Title
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Official Title
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
International Diabetes Center at Park Nicollet, Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
corticosteroid, hyperglycemia, hospital, corticosteroid induced hyperglycemia in the hospital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
the standard recommended care (Methodist Hospital Complete Insulin Orders)
Intervention Type
Drug
Intervention Name(s)
NPH insulin plus Complete Insulin Orders
Other Intervention Name(s)
lantus, glargine, humalog, lispro
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Complete Insulin Orders
Other Intervention Name(s)
lantus, glargine, humalog, lispro
Intervention Description
3-part insulin which includes background, meal-time and correction factor
Primary Outcome Measure Information:
Title
Mean Blood Glucose of All Readings
Description
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 < 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Bergenstal, MD
Organizational Affiliation
International Diabetes Center at Park Nicollet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Park Nicollet Health Services Methodist Hospital
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19454391
Citation
Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.
Results Reference
background
PubMed Identifier
8440759
Citation
Derendorf H, Hochhaus G, Mollmann H, Barth J, Krieg M, Tunn S, Mollmann C. Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. J Clin Pharmacol. 1993 Feb;33(2):115-23. doi: 10.1002/j.1552-4604.1993.tb03930.x.
Results Reference
background
PubMed Identifier
16901792
Citation
Donihi AC, Raval D, Saul M, Korytkowski MT, DeVita MA. Prevalence and predictors of corticosteroid-related hyperglycemia in hospitalized patients. Endocr Pract. 2006 Jul-Aug;12(4):358-62. doi: 10.4158/EP.12.4.358.
Results Reference
background
PubMed Identifier
26492541
Citation
Grommesh B, Lausch MJ, Vannelli AJ, Mullen DM, Bergenstal RM, Richter SA, Fish LH. HOSPITAL INSULIN PROTOCOL AIMS FOR GLUCOSE CONTROL IN GLUCOCORTICOID-INDUCED HYPERGLYCEMIA. Endocr Pract. 2016 Feb;22(2):180-9. doi: 10.4158/EP15818.OR. Epub 2015 Oct 22.
Results Reference
derived
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Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
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