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

HealthPartners Institute

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia

Treatments: Drug: Complete Insulin Orders; Drug: NPH insulin plus Complete Insulin Orders

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01184014

04000-10-C

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Experimental group

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).

Treatment:

Drug: NPH insulin plus Complete Insulin Orders

Control group

Active Comparator group

Description:

the standard recommended care (Methodist Hospital Complete Insulin Orders)

Treatment:

Drug: Complete Insulin Orders