Clinical trial NCT01763567: Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
Official title: A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: Medtronic
Diabetes
Hospital
Continuous Glucose Monitor
Intensive Care Unit
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.

Detailed description: Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:

1. Device Performance:

   * Functionality of HGMS
   * Alerts/Alarms Specificity and Sensitivity
   * System Workflow
2. Safety:

   * Descriptive statistics will be used to characterize safety events
   * Moderate and severe anticipated device and procedure related adverse events
   * All serious adverse events and unanticipated adverse device effects related events

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is admitted to the ICU
3. Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
4. 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
5. Subject has anticipated life expectancy greater than 96 hours
6. Subject has recent platelet count greater than 30,000 per micro-liter

Exclusion Criteria:

1. 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
2. Subject is currently participating in another investigational drug or device study
3. Subject is pregnant, as determined by hospital admission
4. Subject is receiving treatment that includes Hydroxyurea.

Primary outcomes:
measure: Device Performance: Accuracy of HGMS
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
measure: Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected
timeFrame: up to 72 hours
measure: Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected
timeFrame: 72 hours
measure: Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert
timeFrame: Up to 72 hours
measure: Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert
timeFrame: Up to 72 hours
Locations:
city: Kansas City
country: United States
facility: St Luke's Hospital Mid America Heart Institute
state: Missouri
Study officials:
affiliation: St Luke's Hospital - Mid America Heart Institute
name: Mikhail Kosiborod, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.