Comparative Trial Between 3 Types of Insulin Infusion Protocols

This study has been completed.

Study NCT00582309 Information provided by University of New Mexico

First Received on December 19, 2007. Last Updated on August 3, 2011 History of Changes

Results First Received: September 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Factorial Assignment; Masking: 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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow: Overall Study

	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion
STARTED	56	49	46
COMPLETED	56	49	44 ^[1]
NOT COMPLETED	0	0	2
Protocol Violation	0	0	2

[1]	2 did not have enough data collected to be used

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Glucommander-Guided Intravenous Insulin Infusion	Standard Intravenous Insulin Infusion Algorithm	Simple Calculated Intravenous Insulin Infusion	Total
Number of Participants [units: participants]	56	49	46	151
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	35	33	27	95
>=65 years	21	16	19	56
Age [units: years] Mean ± Standard Deviation	61.5 ± 10.6	60.6 ± 12.3	61.4 ± 13.6	61.2 ± 11.3
Gender [units: participants]
Female	24	25	23	72
Male	32	24	23	79
Region of Enrollment [units: participants]
United States	56	49	46	151

Outcome Measures

1. Primary:

Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group. [ Time Frame: 24 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor may evaluate results and choose not to be a coauthor on the publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of trial. Variable length of stay the first 48 hours was analyzed as the sample size decreased after that.

Results Point of Contact:

Name/Title: Gary Iwamoto
Organization: UNM
phone: 505-272-4751
e-mail: giwamoto@salud.unm.edu

No publications provided

Responsible Party:	Gary Iwamoto, MD, University of New Mexico
ClinicalTrials.gov Identifier:	NCT00582309 History of Changes
Other Study ID Numbers:	HRRC 06-288
Study First Received:	December 19, 2007
Results First Received:	September 12, 2009
Last Updated:	August 3, 2011
Health Authority:	United States: Institutional Review Board