N/A
Completed N=19
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
Source: ClinicalTrials.gov NCT01763567 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Device Performance: Accuracy of HGMS — 12.8 percent difference
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Performance: Accuracy of HGMS |
12.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01763567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.