Hyperglycemia
Conditions
Keywords
corticosteroid, hyperglycemia, hospital, corticosteroid induced hyperglycemia in the hospital
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.
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).
Interventions
DRUGNPH 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.
DRUGComplete Insulin Orders
3-part insulin which includes background, meal-time and correction factor
Sponsors
International Diabetes Center at Park Nicollet
Sanofi
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 \< 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Glucose of All Readings | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment from May 2011 to August 2012. Location: Hospital.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group a study-specific steroid NPH dosing algorithm plus standard recommended care | 35 |
| Control Group the standard recommended care (Methodist Hospital Complete Insulin Orders) | 37 |
| Total | 72 |
Baseline characteristics
| Characteristic | Control Group | Experimental Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 21 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 14 Participants | 32 Participants |
| Age, Continuous | 71.6 years STANDARD_DEVIATION 44.6 | 67.1 years STANDARD_DEVIATION 14.2 | 69.4 years STANDARD_DEVIATION 33.1 |
| Region of Enrollment United States | 37 participants | 35 participants | 72 participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 |
Outcome results
Primary
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Mean Blood Glucose of All Readings | 157.2 mg/dL | Standard Deviation 6.1 |
| Control Group | Mean Blood Glucose of All Readings | 181.8 mg/dL | Standard Deviation 32.6 |