Blood glucose performance test

ISRCTN	ISRCTN11379850
DOI	https://doi.org/10.1186/ISRCTN11379850
Protocol serial number	ADC-UK-PMS-16030
Sponsor	Abbott Diabetes Care Ltd
Funder	Abbott Diabetes Care Ltd

Submission date: 10/02/2017
Registration date: 12/05/2017
Last edited: 20/10/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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?
Participants 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 is no direct benefit to the participant for 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. St James’s University Hospital (UK)
3. North Manchester General Hospital (UK)
4. Windrush Medical Centre (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

Contact information

Dr Pamela Reid
Public

Range Road
Witney
OX29 0YL
United Kingdom

Phone	+44 (0)1993 863024
Email	Pamela.reid@abbott.com

Study information

Primary study design	Interventional
Study design	Multi-centre prospective single-arm study
Secondary study design	Non randomised study
Scientific title	Blood glucose performance test: a multi-centre prospective single-arm study
Study objectives	Current study objectives as of 20/10/2026: To assess the accuracy of blood glucose monitoring systems using capillary or venous whole blood samples from participants with diabetes and comparing the results to glucose readings obtained from a YSI analyser as a reference. _____ Previous study objectives: 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(s)	NRES Committee: London – Westminster Research Ethics Committee, 22/12/2016, ref: 16/LO/2217
Health condition(s) or problem(s) studied	Diabetes mellitus
Intervention	Current interventions as of 20/10/2026: Whole blood obtained from the participant (venous whole blood from venepuncture or capillary whole blood from a fingerprick) will be tested on the blood glucose monitoring systems, the HemoCue analyser and the YSI analyser. _____ Previous interventions: 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	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Blood glucose strips
Primary outcome measure(s)	Current primary outcome(s) as of 20/10/2026: 1. The accuracy of the blood glucose monitoring system(s) compared to the YSI reference analyser using fingerprick capillary or venous whole blood samples _____ Previous primary outcome(s): 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
Key secondary outcome measure(s)	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
Completion date	31/12/2029

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	16 Years
Upper age limit	120 Years
Sex	All
Target sample size at registration	55
Key inclusion criteria	1. Diagnosed with diabetes 2. ≥16 years of age
Key exclusion criteria	Current key exclusion criteria as of 20/10/2026: 1. Has already participated in the study event that day 2. Member of the site study team _____ Previous key exclusion criteria: 1. Participated in the study event already 2. Member of the site study team
Date of first enrolment	01/02/2017
Date of final enrolment	31/12/2029

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Ipswich Hospital

Heath Road
Ipswich
IP4 5PD
England

Leeds Teaching Hospitals NHS Trust

St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
England

North Manchester General Hospital

Delaunays Road
Crumpsall
Manchester
M8 5RB
England

Windrush Medical Centre

Welch Way
Witney
OX28 6JS
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from ADC_Witney_ClinicalAffairs@abbott.com.

Study outputs

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

Editorial Notes

20/10/2026: The following changes were made to the study record:
1. The study objectives were changed.
2. The interventions were changed.
3. The primary outcome(s) were changed.
4. The key exclusion criteria were changed.
5. The Date of final enrolment was changed from 31/12/2028 to 31/12/2029.
6. The study participating centres were updated.
7. The plain English summary was updated to reflect these changes.
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.