Trial Outcomes & Findings for Comparative Trial Between 3 Types of Insulin Infusion Protocols (NCT NCT00582309)
NCT ID: NCT00582309
Last Updated: 2015-06-23
Results Overview
The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG \< 120, and maintaining the target range thereafter.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
24 hours
Results posted on
2015-06-23
Participant Flow
Participant milestones
| Measure |
Glucommander-Guided Intravenous Insulin Infusion
Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
|
Standard Intravenous Insulin Infusion Algorithm
Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
|
Simple Calculated Intravenous Insulin Infusion
Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
49
|
46
|
|
Overall Study
COMPLETED
|
56
|
49
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Glucommander-Guided Intravenous Insulin Infusion
Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
|
Standard Intravenous Insulin Infusion Algorithm
Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
|
Simple Calculated Intravenous Insulin Infusion
Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
Baseline Characteristics
Comparative Trial Between 3 Types of Insulin Infusion Protocols
Baseline characteristics by cohort
| Measure |
Glucommander-Guided Intravenous Insulin Infusion
n=56 Participants
Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
|
Standard Intravenous Insulin Infusion Algorithm
n=49 Participants
Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
|
Simple Calculated Intravenous Insulin Infusion
n=46 Participants
Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
|
Total
n=151 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
49 participants
n=7 Participants
|
46 participants
n=5 Participants
|
151 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG \< 120, and maintaining the target range thereafter.
Outcome measures
| Measure |
Glucommander-Guided Intravenous Insulin Infusion
n=56 Participants
Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
|
Standard Intravenous Insulin Infusion Algorithm
n=49 Participants
Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
|
Simple Calculated Intravenous Insulin Infusion
n=44 Participants
Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
|
|---|---|---|---|
|
Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.
|
5 Time to reach glycemic control in hours
Standard Deviation 3.7
|
10.1 Time to reach glycemic control in hours
Standard Deviation 10.3
|
7.7 Time to reach glycemic control in hours
Standard Deviation 9.0
|
Adverse Events
Standard Intravenous Insulin Infusion Algorithm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Simple Calculated Intravenous Insulin Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glucommander-Guided Intravenous Insulin Infusion
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 Sponsor may evaluate results and choose not to be a coauthor on the publication.
- Publication restrictions are in place
Restriction type: OTHER