GlucoClear ICU Study

An ICU Study of Safety and Accuracy Using the GlucoClear CGM System

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02238041

Enrollment

Registered

2014-09-12

Start date

2014-12-31

Completion date

2015-12-31

Last updated

2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Blood Glucose Monitoring

Keywords

Glucose monitoring, Intensive care unit

Brief summary

The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.

Detailed description

Design: Non-randomized, non-treatment, prospective, open label Study. The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System. After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours. Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period. After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.

Interventions

DEVICEGlucoClear System

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent

Exclusion criteria

Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study

Design outcomes

Primary

Measure	Time frame	Description
15/20% Accuracy	During 72 hours of anticipated Sensor dwell time.	15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values \< 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL)

Secondary

Measure	Time frame	Description
12/15% Trend Accuracy	During 72 hours of anticipated Sensor dwell time.	12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is \< 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026