Comparative Trial Between 3 Types of Insulin Infusion Protocols

• ClinicalTrials.gov Identifier: NCT00582309
• Recruitment Status: Completed
• First Posted: December 28, 2007
• Results First Posted: January 25, 2010
• Last Update Posted: June 23, 2015
• Sponsor: University of New Mexico
• Collaborator: Sanofi
• Information provided by (Responsible Party): Gary Iwamoto, University of New Mexico

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hyperglycemia
• Interventions: Procedure: Glucommander-Guided Intravenous Insulin Infusion; Procedure: Standard Intravenous Insulin Infusion; Procedure: Simple Calculated Intravenous Insulin Infusion
• Enrollment: 151

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
Arm/Group Description	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 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 Use of of standard sliding scale to adjust insulin dose
Period Title: Overall Study
Started	56	49	46
Completed	56	49	44 [1]
Not Completed	0	0	2
Reason Not Completed
Protocol Violation	0	0	2
[1] 2 did not have enough data collected to be used

Baseline Characteristics

Arm/Group Title		Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion	Total
Arm/Group Description		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 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 Use of of standard sliding scale to adjust insulin dose	Total of all reporting groups
Overall Number of Baseline Participants		56	49	46	151
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	49 participants	46 participants	151 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	35 62.5%	33 67.3%	27 58.7%	95 62.9%
	>=65 years	21 37.5%	16 32.7%	19 41.3%	56 37.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	56 participants	49 participants	46 participants	151 participants
		61.5 (10.6)	60.6 (12.3)	61.4 (13.6)	61.2 (11.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	49 participants	46 participants	151 participants
	Female	24 42.9%	25 51.0%	23 50.0%	72 47.7%
	Male	32 57.1%	24 49.0%	23 50.0%	79 52.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	56 participants	49 participants	46 participants	151 participants
		56	49	46	151

Outcome Measures

1. Primary Outcome

Title	Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
Arm/Group Description:	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 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 Use of of standard sliding scale to adjust insulin dose
Overall Number of Participants Analyzed	56	49	44
Mean (Standard Deviation); Unit of Measure: Time to reach glycemic control in hours
	5 (3.7)	10.1 (10.3)	7.7 (9.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glucommander-Guided Intravenous Insulin Infusion, Standard Intravenous Insulin Infusion Algorithm, Simple Calculated Intravenous Insulin Infusion
	Comments	Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher's Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher's least significant difference method.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Original Power Analysis: The expected differences in mean blood glucose concentration between groups are > 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values < 0.05.
	Method	ANOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
Arm/Group Description	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 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 Use of of standard sliding scale to adjust insulin dose
All-Cause Mortality
	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/59 (0.00%)	0/49 (0.00%)	0/46 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/56 (0.00%)	0/49 (0.00%)	0/46 (0.00%)

Limitations and Caveats

Limitations of trial. Variable length of stay the first 48 hours was analyzed as the sample size decreased after that.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor may evaluate results and choose not to be a coauthor on the publication.

Results Point of Contact

• Name/Title: Gary Iwamoto
• Organization: UNM
• Phone: 505-272-4751
• EMail: giwamoto@salud.unm.edu

• Responsible Party: Gary Iwamoto, University of New Mexico
• ClinicalTrials.gov Identifier: NCT00582309
• Other Study ID Numbers: HRRC 06-288
• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Results First Submitted: September 12, 2009
• Results First Posted: January 25, 2010
• Last Update Posted: June 23, 2015