Blood glucose performance test
| ISRCTN | ISRCTN11668805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11668805 |
| Secondary identifying numbers | ADC-PMS-GLU-12014 |
- Submission date
- 17/11/2014
- Registration date
- 27/01/2015
- Last edited
- 09/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
The Diabetes Centre
The Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom
| Gerry.Rayman@ipswichhospital.nhs.uk |
Study information
| Study design | Single-centre prospective open single-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Blood glucose performance test |
| Study acronym | NA |
| Study objectives | 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(s) | NRES Committee East of England - Cambridge Central, 01/11/2013, REC ref: 13/EE/0258 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 29/10/2014 |
| Completion date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 50 per study event |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/10/2014 |
| Date of final enrolment | 31/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Heath Road
Ipswich
IP4 5PD
United Kingdom
Sponsor information
Industry
c/o Joe Bugler
Range Road
Witney
OX29 0YL
United Kingdom
"ROR" |
https://ror.org/03wnay029 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| 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
09/07/2020: The trial contact details have been made publicly visible.
