The aim of this study is to determine the measurement accuracy of Roche Diagnostics' new Point of Care Test (POCT) glucose meter Cobas Pulse (formerly ACI3) on venous, arterial, and capillary whole blood samples from adult hospital patients…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen speciale klassen, patienten met en zonder diabetes
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research parameter is the glucose concentration. To assess whether
the Cobas Pulse shows sufficient measuring accuracy when used in practice, the
following assessment criteria are used:
1. Precision:
- samples with a glucose concentration <4.2 mmol / L (75 mg / dL) the SD is *
0.3 mmol / L (6 mg / dL).
- samples with a glucose concentration * 4.2 mmol / L (75 mg / dL) the CV is
<6.0%.
2. Trueness:
- * 95% of the glucose results of samples with a glucose concentration <4.2
mmol / L (75 mg / dL) correspond well with the results of the reference method
(difference maximum 0.7 mmol / L; 12 mg / dL) .
- * 95% of the glucose results of samples with a glucose concentration * 4.2
mmol / L (75 mg / dL) correspond well with the results of the reference method
(difference maximum 12%).
&
- * 98% of the glucose results from samples with a glucose concentration <4.2
mmol / L (75 mg / dL) correspond well with the results of the reference method
(difference maximum 0.8 mmol / L; 15 mg / dL) .
- * 98% of the glucose results of samples with a glucose concentration * 4.2
mmol / L (75 mg / dL) correspond well with the results of the reference method
(difference maximum 15%).
Secondary outcome
In order to detect and explain possible interference, the hematocrit, the
sodium concentration and the partial oxygen pressure (pO2) are determined in
addition to the glucose measurement per patient (on the iStat from material of
the same sample). As additional information, the medication used and, if
established, the diagnosis is also sent.
Background summary
Roche Diagnostics has developed a new POCT device (Cobas Pulse; formerly ACI 3)
that can measure a patients glucoseconcentration next to or near the patient's
bed. In addition, this meter can manage data itself and forward it to the
hospital information system (ZIS).
A previous study has already tested whether this device can measure the
glucose concentration correctly (ACI 3; NL69448.100.19). In this follow-up
study, the usage and accuracy of measuring of the glucosemeter is tested in
practice, by having the measurement carried out by employees who normally work
with POCT equipment in their function. These so-called operators must train
themselves for measuring with the Cobas Pulse using the supplied instructions.
In order to determine the accuracy of measurements of the Cobas Pulse by
operators in practice, blood from hospital patients (venous, arterial and
capillary) of the same sample is measured both on the new glucose meter, on an
already qualified routine glucose meter and on a reference method. By comparing
the results with each other, the measurement accuracy when using the new
glucosemeter can be determined in practice .
This study is designed in such a way that, after a positive evaluation, the
requirements for both CE marking according to IVDD and IVDR in Europe as well
as an FDA 510 (k) and a CLIA statement in the United States can be met.
Study objective
The aim of this study is to determine the measurement accuracy of Roche
Diagnostics' new Point of Care Test (POCT) glucose meter Cobas Pulse (formerly
ACI3) on venous, arterial, and capillary whole blood samples from adult
hospital patients when used in practice .
The Cobas Pulse has been improved compared to its predecessor in both ease of
use (smaller and therefore more handy) and measuring comfort (blood is easier
to draw than before). A previous study has already tested whether this device
can correctly measure the glucose concentration (ACI 3; NL69448.100.19). In
this follow-up study, the use and accuracy of measuring the glucose meter is
tested by having the measurement carried out by employees who normally work
with POCT equipment in their function in practice .
Measurement accuracy is determined by comparing the results of the Cobas Pulse
with those of reference methods analyzed on a Roche Cobas 6000. The collected
reference samples are coded and transferred to Roche for measurement. As in the
ACI 3 study, residual material obtained from regular blood samples (requested
by the treating physician) is used as much as possible.
Study design
The study is designed in two phases:
a. Introductory phase: In this part of the study protocol, employees who
normally work with POCT equipment are introduced to the instrument and the
glucose test strip to be used. These employees, also called "operators", must
train themselves to measure with the Cobas Pulse using the supplied
instructions. In the unlikely event that the operation of the device with the
supplied instructions is not clear, a telephone number is available for help
questions.
In addition to measuring the glucose concentration with the Cobas Pulse, the
glucose concentration will also be measured on an already qualified glucose
meter from another manufacturer (Nova StatStrip). For the use of this glucose
meter, the operators are trained under supervision, by measuring control
samples.
The preparation of the reference samples is not carried out by an operator, but
after training by an employee of the laboratory.
b. Main phase: The Cobas Pulse will be tested on measuring precision and
measuring accuracy in practice. The measurement precision will be determined by
two operators, who will measure both regular control and linearity control
samples for six days each.
A comparison between the measurement results of the Cobas Pulse with the
reference method to determine the measurement accuracy in practice will be
carried out on different cohorts:
* About a 100 arterial + venous samples from adult diabetic or non-diabetic
patients, of which at least 10 are from intensive care (IC). All measurements
on arterial samples are performed on residual material.
* About a 100 venous from adult diabetic or non-diabetic patients, of which at
least 10 from intensive care (IC). All measurements on venous samples are
performed on residual material.
* About a 100 capillary samples from adult diabetic or non-diabetic patients,
NO patients requiring intensive care (IC). A finger prick is required for this.
It is expected that a fingerstick is sufficient to measure on both the Cobas
Pulse and the Nova StatStrip.
In addition to the glucose measurement on the Cobas Pulse, the glucose will
also be measured on the Nova StatStrip. Both measurements are performed on
location (Catharina hospital Eindhoven or Isala Clinics).
The sodium concentration, the hematocrit and the partial oxygen pressure (pO2)
will be meausred with an Aboot IStat in each patient. These measurement data
are also recorded. As additional information, the medication used and, if
established, the diagnosis is sent along. The samples for the reference method
are coded before being send to Roche Indianapolis, where they will be measured.
NB. The added study protocol is an official but general version applicable to
all hospitals involved. It has been decided for the Catharina Hospital and the
Isal Clinics to not include pediatric and neonatal patients in this validation.
This has been confirmed in the site-specific protocol that has also been added.
Study burden and risks
There is no additional risk to the patient. The tax only consists of reading
and possibly signing the information letter and the accompanying informed
consent form.
A quality analysis will be performed between the new glucose POCT meter (Cobas
Pulse) and a reference method when used in practice. Almost all of the
validation can be performed on residual material from patient samples that are
routinely collected (all venous and arterial samples).
Within Catharinea Hospital and Isala Clinics, patients are already regularly
checked for their glucose by means of a POCT device that is currently being
used. A good example of this is the patients with diabets who come for a
regular check-up in which their glucose meter at home is checked. In addition,
the glucose concentration is also checked in clinical patients about 100,000
times a year by a POCT measurement. For the capillary samples only, additional
material will be collected in addition to the whole blood required for the
routine glucose measurement for a measurement on the Cobas Pulse and the Nova
StatStrip. Strictly speaking, this is not residual material, but for both
patient groups, a fingerstick provides sufficient material to be able to
measure on the Cobas Pulse and the Nova StatStrip in addition to the routine
meter. Only in a few cases will a second finger prick be requested to be able
to perform all measurements (estimate <2%). The finger prick is seen as one of
the least invasive ways to draw blood, which is often used in the hospital with
patient groups that are difficult or non-venous to prick.
An informed consent form will be requested for the use of the residual material
and / or the additional collection of a maximum of 100 µL of capillary blood
during a regular blood collection, the search for the medication data and the
diagnosis.
Hague Road 9115
Indianapolis IN 46250-0457
US
Hague Road 9115
Indianapolis IN 46250-0457
US
Listed location countries
Age
Inclusion criteria
Adult.
Signed informed consent (for critically ill, before admittance to the ICU after
scheduled operation).
Diabetic and non-diabetic.
Exclusion criteria
Minor (< 18 year)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73544.100.20 |