CE mark study of a home self-test system for blood cell count and ear temperature

ISRCTN	ISRCTN71085103
DOI	https://doi.org/10.1186/ISRCTN71085103
Secondary identifying numbers	HCM003.CT.042

Submission date: 29/11/2013
Registration date: 12/12/2013
Last edited: 30/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof David D'Cruz
Scientific

Louise Coote Lupus Unit
St Thomas' Hospital
Westminster Bridge
London
SE1 7EH
United Kingdom

Study information

Study design	Observational CE mark study
Primary study design	Interventional
Secondary study design	Other
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	London City-East, 04/12/2013, Ref: 14/LO/0021
Health condition(s) or problem(s) studied	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
Primary outcome measure	To prove the device can be CE marked for its intended use
Secondary outcome measures	No secondary outcome measures
Overall study start date	17/02/2014
Completion date	30/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Key inclusion criteria	1. Patients attending clinics within St Thomas' Hospital, London, UK 2. Aged 18 - 85
Key exclusion criteria	Leukaemic patients
Date of first enrolment	17/02/2014
Date of final enrolment	30/05/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Louise Coote Lupus Unit

London
SE1 7EH
United Kingdom

Sponsor information

Philips Healthcare Incubator (Home Clinical Monitoring) (Netherlands)
Industry

Building 34
High Tech Campus
Eindhoven
5656AE
Netherlands

Website	http://www.healthcare.philips.com/gb_en/
"ROR"	https://ror.org/02p2bgp27

Funders

Funder type

Industry

Philips Electronics (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

23/01/2017: No publications found in PubMed, verifying study status with principal investigator.