Plain English Summary
Background and study aims
There is no home test system for self-test blood cell count and ear-temperature test in the home. This study aims to validate the use of a new system for this purpose.
What does the study involve?
The new system will measure total white blood cell count (WBC), Granulocyte cell count (GRN) and haemoglobin (HGB) within finger prick blood. The new system is based on proven technology, and this study will achieve CE marking (the declaration from the manufacturer that the device complies with EU regulations).
Who can participate?
Patients attending routine clinics at St Thomas Hospital, London, aged 18-85, male or female, of a range of educational backgrounds, who will be selected to provide a range of WBC, GRN and HGB values to help evaluate the accuracy performance of the new device.
The study involves assessment of the ability of patients to perform a self-test using finger prick blood and to obtain a correct result. Each patient will also be assessed for their ability to perform ear temperature measurement and complete a health assessment questionnaire. The ability of patients to correctly test before and after training will be determined. Patients will also use the system in the home and will complete a questionnaire regarding ease of use.
What are the possible benefits and risks of participating?
There are no benefits to patients participating. In the longer term, once that CE marking has been obtained, patients could benefit from using the device in the home if their doctors think it is useful to monitor their blood status at home. Risk involved in participating is no greater than the risks that people with diabetes are exposed to in terms of finger prick sampling (ie some possible bruising).
Where is the study run from?
St Thomas Hospital, London, UK.
When is the study starting and how long is it expected to run for?
The study is expected to run for 3-4 months.
Who is funding the study?
Philips Electronics [Philips Healthcare Incubator] are funding the project.
Who is the main contact?
Dr Martin Payne
martin.payne@philips.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HCM003.CT.042
Study information
Scientific title
Protocol for the commercial study to enable CE marking for the sale of a whole white blood cell count, granulocyte blood cell count, and haemoglobin-measuring device and ear thermometer with telehub, within the European Union
Acronym
Study hypothesis
This CE mark commercial study should prove that the change in intended use for existing device technology to measure total white blood cell count (WBC), granulocyte (GRN) and haemoglobin (HGB) levels from finger capillary blood in the home by self-test users, provides clinically acceptable performance, and that patients can additionally measure their ear temperature.
Ethics approval
London City-East, 04/12/2013, Ref: 14/LO/0021
Study design
Observational CE mark study
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
This is CE mark trial to prove device suitability for intended use - no drug therapy, no patient specific state monitoring sought
Intervention
The purpose of the study is to provide evidence that after training patients are able to perform a finger prick and add a blood droplet to a cartridge for successful and accurate measurement of white blood cell count and haemoglobin level using a device that has been designed for self-test use, based on a laboratory device. Patients are also asked to perform an ear temperature measurement following training and complete a questionnaire.
Patients visiting the clinic perform finger prick/ear-temperature measurements over 4 days, with training after an unaided first attempt. They are monitored unaided for the subsequent three visits.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
To prove the device can be CE marked for its intended use
Secondary outcome measures
No secondary outcome measures
Overall trial start date
17/02/2014
Overall trial end date
30/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients attending clinics within St Thomas' Hospital, London, UK
2. Aged 18 - 85
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
Leukaemic patients
Recruitment start date
17/02/2014
Recruitment end date
30/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Louise Coote Lupus Unit
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Philips Healthcare Incubator (Home Clinical Monitoring) (Netherlands)
Sponsor details
Building 34
High Tech Campus
Eindhoven
5656AE
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Philips Electronics (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary