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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Barriers to the Implementation of Complete Insulin Order Sets

NCT00813280

Hyperglycemia

COMPLETED

The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients

NCT01810952

Hyperglycemia Diabetes Mellitus

COMPLETED PHASE4

Prandial Insulin Dosing in Hospitalized Patients

NCT01101867

Diabetes Admitting Hospital Non-critically Ill

COMPLETED PHASE4

NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens

NCT02758522

Diabetes Mellitus Hyperglycemia

COMPLETED PHASE4

Admission Glucose ICU Study

NCT00569322

Hyperglycemia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

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

Group Type EXPERIMENTAL

NPH insulin plus Complete Insulin Orders

Intervention Type 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.

Control group

the standard recommended care (Methodist Hospital Complete Insulin Orders)

Group Type ACTIVE_COMPARATOR

Complete Insulin Orders

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NPH insulin plus Complete Insulin Orders

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

Complete Insulin Orders

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lantus glargine humalog lispro lantus glargine humalog lispro

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No