Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
|
Sponsor:
|
Park Nicollet Institute |
|---|---|
|
Collaborators:
|
International Diabetes Center at Park Nicollet Sanofi-Aventis |
|
Information provided by:
|
Park Nicollet Institute |
|
ClinicalTrials.gov Identifier:
|
NCT01184014 |
Purpose
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.
|
Condition
|
Intervention
|
Phase
|
|---|---|---|
| Hyperglycemia | Drug: NPH insulin plus Complete Insulin Orders Drug: Complete Insulin Orders |
Phase IV |
Study Type: Interventional Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment Official Title: Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Further study details as provided by Park Nicollet Institute:
- the proportion of blood glucose readings between 70 and 180 mg/dL, inclusive [ Time Frame: discharge or until after their 5th day in the hospital ] [ Designated as safety issue: No ]
as stated above
- the mean blood glucose of all blood glucose readings [ Time Frame: 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 ] [ Designated as safety issue: No ]
as stated above
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
|
Arms
|
Assigned Interventions
|
|---|---|
| Experimental group: Experimental
a study-specific steroid NPH dosing algorithm plus standard recommended care
Intervention: Drug: NPH insulin plus Complete Insulin Orders
|
Drug: 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.
Other Names:
|
| Control group: Active Comparator
the standard recommended care (Methodist Hospital Complete Insulin Orders)
Intervention: Drug: Complete Insulin Orders
|
Drug: Complete Insulin Orders
3-part insulin which includes background, meal-time and correction factor
Other Names:
|
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).
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 <30mL/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.
