Trial Outcomes & Findings for Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients (NCT NCT00645827)
NCT ID: NCT00645827
Last Updated: 2014-09-15
Results Overview
Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Within 24 hours after cessation of IV insulin
Results posted on
2014-09-15
Participant Flow
Subjects were enrolled between April 2008 to February 2009.
78 subjects consented. 3 subjects excluded at screening. Of the 75 subjects remaining, only 57 subjects seen by the principal investigator (PI) because the patient's healthcare provider had to call the PI right before the intravenous insulin infusion (III) was discontinued. PI excluded 26 more subjects at III cessation--31 subjects randomized.
Participant milestones
| Measure |
Insulin Infusion Conversion Equation
Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
|
Control
Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
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|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients
Baseline characteristics by cohort
| Measure |
Insulin Infusion Conversion Equation
n=14 Participants
Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
|
Control
n=17 Participants
Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age > 18 years old
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours after cessation of IV insulinFingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL
Outcome measures
| Measure |
Insulin Infusion Conversion Equation
n=14 Participants
Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
|
Control
n=17 Participants
Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.
|
|---|---|---|
|
Percentage of Blood Glucose Values Within 80-140 mg/dL
|
54.8 percentage of blood glucose values
Interval 0.42 to 0.68
|
21.2 percentage of blood glucose values
Interval 0.1 to 0.33
|
SECONDARY outcome
Timeframe: Within 24 hours after cessation of IV insulinOutcome measures
Outcome data not reported
Adverse Events
Insulin Infusion Conversion Equation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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