Trial Outcomes & Findings for Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia (NCT NCT01184014)
NCT ID: NCT01184014
Last Updated: 2018-06-13
Results Overview
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
COMPLETED
PHASE4
72 participants
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
2018-06-13
Participant Flow
Recruitment from May 2011 to August 2012. Location: Hospital.
Participant milestones
| Measure |
Experimental Group
a study-specific steroid NPH dosing algorithm plus standard recommended care
|
Control Group
the standard recommended care (Methodist Hospital Complete Insulin Orders)
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Baseline characteristics by cohort
| Measure |
Experimental Group
n=35 Participants
a study-specific steroid NPH dosing algorithm plus standard recommended care
|
Control Group
n=37 Participants
the standard recommended care (Methodist Hospital Complete Insulin Orders)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 44.6 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 33.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 daysStarting 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
Outcome measures
| Measure |
Experimental Group
n=30 Participants
a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).
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.
|
Control Group
n=31 Participants
the standard recommended care (Methodist Hospital Complete Insulin Orders)
Complete Insulin Orders: 3-part insulin which includes background, meal-time and correction factor
|
|---|---|---|
|
Mean Blood Glucose of All Readings
|
157.2 mg/dL
Standard Deviation 6.1
|
181.8 mg/dL
Standard Deviation 32.6
|
Adverse Events
Experimental Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place