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

NCT01763567 | Completed Results

• 1 other identifier: CEP244
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia

Keywords

Medtronic; Diabetes; Hospital; Continuous Glucose Monitor; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Device Performance: Accuracy of HGMS

  Mean Absolute Relative Difference (MARD), calculated as the absolute difference of \[(sensor glucose values - iSTAT glucose values) / iSTAT glucose values\]. The portable i-STAT handheld makes patient-side testing easy: * Requires no special sample preparation or user calibration; maintenance is minimal * Weighs 18 ounces, making it portable * Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results: * The system prompts users step by step through the testing process * Operator and patient information can be entered via barcode scanner * Operator lockout prevents unauthorized users from performing or viewing test results * Test results are uploaded automatically when the i-STAT handheld is placed in a downloader

  up to 72 hours

Other Outcomes (4)

• Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected

  up to 72 hours

• Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected

  72 hours

• Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert

  Up to 72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia

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 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (1)

St Luke's Hospital Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

• Kosiborod M, Gottlieb RK, Sekella JA, Peterman D, Grodzinsky A, Kennedy P, Borkon MA. Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit. BMJ Open Diabetes Res Care. 2014 Jul 21;2(1):e000037. doi: 10.1136/bmjdrc-2014-000037. eCollection 2014.

  PMID: 25452874 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Julie Sekella
• Organization: Medtronic, Inc.

Julie.Sekella@medtronic.com

818-576-5000

Study Officials

• Mikhail Kosiborod, M.D

  St Luke's Hospital - Mid America Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 9, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 7, 2015
• Results First Posted: May 7, 2015

Record last verified: 2015-05

Locations

US (1)