Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)

Completed

Conditions studied: Hyperglycemia

In brief

The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.

Key facts

Study ID

NCT01763567

Run by

Medtronic MiniMed, Inc.

People needed

19

Starts

2012-03-01

Expected to finish

2012-09-01

Last updated by the study team

2015-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is at least 18 years old
• Subject is admitted to the ICU
• Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
• Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours
• a. Including patients with no previous diagnosis of Diabetes Mellitus
• Subject has anticipated life expectancy greater than 96 hours
• Subject has recent platelet count greater than 30,000 per micro-liter

You may not qualify if…

• Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study
• Subject is currently participating in another investigational drug or device study
• Subject is pregnant, as determined by hospital admission
• Subject is receiving treatment that includes Hydroxyurea.

Where it is running

• St Luke's Hospital Mid America Heart Institute — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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