Phase 4
N=72
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01184014 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Mean Blood Glucose of All Readings — 157.2; 181.8 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- NPH insulin plus Complete Insulin Orders (Drug); Complete Insulin Orders (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Blood Glucose of All Readings |
157.2; 181.8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01184014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.