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

NCT01184014 | Completed Phase 4 Results

• 1 other identifier: 04000-10-C
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia

Keywords

corticosteroid; hyperglycemia; hospital; corticosteroid induced hyperglycemia in the hospital

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).

Drug: NPH insulin plus Complete Insulin Orders

Control group

ACTIVE COMPARATOR

the standard recommended care (Methodist Hospital Complete Insulin Orders)

Drug: Complete Insulin Orders

Interventions

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.

Also known as: lantus, glargine, humalog, lispro

Experimental group

Complete Insulin Orders DRUG

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

Also known as: lantus, glargine, humalog, lispro

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• International Diabetes Center at Park Nicollet: collaborator
• Sanofi: collaborator

Study Sites (1)

Park Nicollet Health Services Methodist Hospital

Saint Louis Park, Minnesota, 55416, United States

Location

Related Publications (4)

• Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.

  PMID: 19454391 BACKGROUND

• 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.

  PMID: 8440759 BACKGROUND

• 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.

  PMID: 16901792 BACKGROUND

• 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.

  PMID: 26492541 DERIVED

MeSH Terms

Conditions

Hyperglycemia

Interventions

Insulin, Isophane; Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Dr. Richard Bergenstal
• Organization: International Diabetes Center

richard.bergenstal@parknicollet.com

952-993-3796

Study Officials

• Richard M Bergenstal, MD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 13, 2018
• Results First Posted: November 18, 2013

Record last verified: 2013-11

Locations

US (1)