Expired Study
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Saint Louis Park, Minnesota 55416


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.


Study summary:

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).


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.


Study is Available At:


Original ID:

04000-10-C


NCT ID:

NCT01184014


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

HealthPartners Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

72


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard M Bergenstal, MD
Principal Investigator
International Diabetes Center at Park Nicollet

Study Dates

Start Date:August 2010
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:August 2012
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:May 15, 2018
First Received Date:August 16, 2010
First Results Date:September 13, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 th
Safety Issues:False
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

Study Interventions

Intervention Type:Drug
Name:NPH insulin plus Complete Insulin Orders
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.
Arm Name:Experimental group
Other Name:lantus
Intervention Type:Drug
Name:Complete Insulin Orders
Description:3-part insulin which includes background, meal-time and correction factor
Arm Name:Control group
Other Name:lantus

Study Arms

Study Arm Type:Active Comparator
Arm Name:Control group
Description:the standard recommended care (Methodist Hospital Complete Insulin Orders)
Study Arm Type:Experimental
Arm Name:Experimental group
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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:HealthPartners Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:International Diabetes Center at Park Nicollet

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:16901792
Reference Type:Reference
Citation:Derendorf H, Hochhaus G, Möllmann H, Barth J, Krieg M, Tunn S, Möllmann C. Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. J Clin Pharmacol. 1993 Feb;33(2):115-23.
PMID:8440759
Reference Type:Reference
Citation:Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR. Review.
PMID:19454391

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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