Plain English Summary
Background and study aims
The aim of this study is to monitor the performance of on-market (CE marked) blood glucose monitoring systems (blood glucose meters and test strips) designed for people with diabetes to test their blood glucose, especially those people who take insulin. These systems are used as part of standard care of diabetes and are freely available to buy on the market.
Who can participate?
Patients over 16 years of age with diabetes who are willing to provide a blood sample for analysis.
What does the study involve?
You will visit a diabetes clinic or suitable outpatient clinic. The visit is expected to last about 5 to 20 minutes. You will give a blood sample either by venepuncture (the puncture of a vein) or by a fingerprick and the blood will be tested using both the blood glucose monitoring system and the reference method.
What are the possible benefits and risks of participating?
There may be no direct benefit to the subject if they decide to take part in this study. However, the information gained from the results will make an important contribution to ensuring the blood glucose monitoring systems give reliable results for people with diabetes. The risks to taking part in this study are the same as those associated with routine self-blood glucose testing or giving a blood sample. These risks are small but could include pain, bruising, local infection and fainting caused by the lancet or needle used to obtain a blood sample.
Where is the study run from?
The Diabetes Centre, Ipswich Hospital NHS Trust (UK).
When is the study starting and how long is it expected to run for?
The study started in October 2014 and will finish in October 2024.
Who is funding the study?
Abbott Diabetes Care Ltd (UK).
Who is the main contact?
Gerry Rayman
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ADC-PMS-GLU-12014
Study information
Scientific title
Blood glucose performance test
Acronym
NA
Study hypothesis
This aim of this study is to evaluate the accuracy of blood glucose monitoring systems on subjects with diabetes at the study site. The results will be evaluated by comparing results obtained using either venous whole blood obtained by venepuncture or capillary whole blood obtained from a fingerstick and then tested on the blood glucose monitoring system, to whole blood tested on the Yellow Spring Instrument (YSI analyser) reference method.
Ethics approval
NRES Committee East of England - Cambridge Central, 01/11/2013, REC ref: 13/EE/0258
Study design
Single-centre prospective open single-arm trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Diabetes
Intervention
Either:
Venepuncture will be performed and venous whole blood from the subject will be tested on the blood glucose monitoring system, the HemoCue analyser and the YSI analyser as whole blood
Or:
A fingerstick will be performed and capillary whole blood from the subject will be tested on the blood glucose monitoring system. The same fingerstick will be used to collect a blood sample to perform measurements on the HemoCue analyser and the YSI analyser as whole blood
Intervention type
Device
Phase
Drug names
Primary outcome measures
The accuracy of the blood glucose monitoring system compared to the YSI analyser using fingerstick capillary or venous whole blood samples
Secondary outcome measures
N/A
Overall trial start date
29/10/2014
Overall trial end date
31/10/2024
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects has diabetes
2. Subject is willing to provide a whole blood sample for analysis using:
2.1. The blood glucose monitoring systems
2.2. HemoCue analyser
2.3. YSI analyser
3. The subject is able to understand the patient information sheet and sign the informed consent form prior to any clinical investigation plan directed activity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 per study event
Participant exclusion criteria
1. Subject under 16 years of age
2. Subject is unwilling or unable to give consent for a blood sample to be collected
Recruitment start date
29/10/2014
Recruitment end date
31/10/2024
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Diabetes Centre
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Funders
Funder type
Industry
Funder name
Abbott Diabetes Care Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary