NCT02094859

Brief Summary

The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System). The primary safety objective will be assessed by: • Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal. The primary performance objective will be evaluated using the following criteria: 15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values \> 75 mg/dL).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

March 20, 2014

Last Update Submit

March 21, 2014

Conditions

Accurate Blood Glucose Monitoring in Critical Care Setting

Keywords

Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • 15/20% Performance

    15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values \> 75 mg/dL).

    During 72 hours of anticipated Sensor dwell time

Secondary Outcomes (1)

  • 12/12.5% Performance

    During 72 hours of anticipated Sensor dwell time

Study Arms (1)

GlucoClear System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with an anticipated ICU stay of at least 24 hours.

You may qualify if:

  • ≥ 18 years
  • ICU ≥ 24 hours
  • Signed consent

You may not qualify if:

  • Transplant patient
  • Brain injury/surgery patient
  • End stage medical conditions or diseases
  • Restricted venous access
  • History of HIT
  • Contraindication for anti-coagulation or bleeding disorder
  • Positive pregnancy test
  • In other drug, device, or biologic study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University Graz

Graz, A-8036, Austria

Location

Onze-Lieve-Vrouwziekenhuis

Aalst, 9300, Belgium

Location

Study Officials

  • Luc Foubert, MD, PhD

    Onze-Lieve-Vrouwziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 24, 2014

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

BE(1)AU(1)