Clinical trial NCT01184014: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Keywords: corticosteroid
hyperglycemia
hospital
corticosteroid induced hyperglycemia in the hospital
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Sanofi
First posted: 2010-08-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Mean Blood Glucose of All Readings
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis Park
country: United States
facility: Park Nicollet Health Services Methodist Hospital
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.
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.
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.
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.