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

Medtronic

Status: Completed

Conditions: Hyperglycemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01763567

CEP244

Details and patient eligibility

About

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.

Full 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

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.