Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar (glucose) level to become too high. The aim of this study is to monitor the performance of blood glucose monitoring systems (blood glucose meters and test strips) designed for people with diabetes to test their blood glucose.

Who can participate?
Patients aged 16 and over with diabetes

What does the study involve?
Participation for the patient consists of one visit to the study site. The visit is expected to last about 5 to 20 minutes. The participant gives a blood sample either by venepuncture (the puncture of a vein) or by a fingerprick and the blood is tested using both the blood glucose monitoring system and the reference method. The accuracy and precision of the methods are compared.

What are the possible benefits and risks of participating?
There may be no direct benefit to the participant taking part in this study. However, the information gained from the results ensures the blood glucose monitoring systems provide reliable results. The only risks of participating in this study are associated with blood sample collection. These are small but could include pain, bruising, local infection and fainting.

Where is the study run from?
1. Ipswich Hospital (UK)
2. Oxford Centre for Diabetes, Endocrinology and Metabolism (UK)
3. St James’s University Hospital (UK)
4. Salford Royal Hospital (UK)
5. North Manchester General Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2017 to December 2029 (updated 16/07/2019, previously: July 2027)

Who is funding the study?
Abbott Diabetes Care Ltd (UK)

Who is the main contact?
Dr Pamela Reid

Trial website

Contact information



Primary contact

Dr Pamela Reid


Contact details

Range Road
OX29 0YL
United Kingdom
+44 (0)1993 863024

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Blood glucose performance test: a multi-centre prospective single-arm study


Study hypothesis

Assess the accuracy of blood glucose monitoring systems using capillary blood samples according to ISO 15197 and venous blood samples using the Consensus Error Grid.

Ethics approval

NRES Committee: London – Westminster Research Ethics Committee, 22/12/2016, ref: 16/LO/2217

Study design

Multi-centre prospective single-arm study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Diabetes mellitus


Whole blood obtained from the subject (venous whole blood from venepuncture or capillary whole blood from a fingerstick) will be tested on the blood glucose monitoring systems, the HemoCue analyser and the YSI analyser.

Intervention type



Drug names

Primary outcome measure

1. The accuracy of the blood glucose monitoring system compared to the YSI analyser using fingerstick capillary or venous whole blood samples:
1.1. Capillary: Percentage of replicates within ISO15197 2003 or 2015 system accuracy criteria
1.2. Venous: Percentage of responses within each zone of the Consensus Error Grid
Measured at the single study visit

Secondary outcome measures

1. Precision: Mean paired replicate coefficient of variation (Capillary/Venous)
2. Error grid analysis: Percentage of replicates within each zone of the Consensus Error Grid (Capillary)
Measured at the single study visit

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Diagnosed with diabetes
2. ≥16 years of age

Participant type


Age group




Target number of participants

The target is to enroll approximately 55 participants per study event

Participant exclusion criteria

1. Participated in the study event already
2. Member of the site study team

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Ipswich Hospital
United Kingdom

Trial participating centre

Oxford Centre for Diabetes, Endocrinology and Metabolism
United Kingdom

Trial participating centre

St James’s University Hospital
United Kingdom

Trial participating centre

Salford Royal Hospital
M6 8HD
United Kingdom

Trial participating centre

North Manchester General Hospital
M8 5RB
United Kingdom

Sponsor information


Abbott Diabetes Care Ltd

Sponsor details

Range Road
OX29 0YL
United Kingdom

Sponsor type




Funder type


Funder name

Abbott Diabetes Care Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The purpose of this study is to monitor ongoing performance as part of a post-market surveillance program. Results are of limited interest to scientific or medical publications, however if the results highlight any interesting information a manuscript or abstract will be prepared.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/07/2020: The trial contact details have been made publicly visible. 16/07/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/12/2026 to 31/12/2028. 2. The overall end date was changed from 31/07/2027 to 31/12/2029. 3. The intention to publish date was changed from 31/07/2028 to 31/12/2030. 4. The plain English summary was updated to reflect these changes. 12/07/2017: Internal edit.