Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/02/2017
Date assigned
12/05/2017
Last edited
12/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 July 2027

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

Who is the main contact?
Dr Pamela Reid

Trial website

Contact information

Type

Public

Primary contact

Dr Pamela Reid

ORCID ID

Contact details

Range Road
Witney
OX29 0YL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADC-UK-PMS-16030

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Diabetes mellitus

Intervention

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

Drug names

Primary outcome measures

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

01/02/2017

Overall trial end date

31/07/2027

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

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

01/02/2017

Recruitment end date

31/12/2026

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ipswich Hospital
IP4 5PD

Trial participating centre

Oxford Centre for Diabetes, Endocrinology and Metabolism
OX3 7LE

Trial participating centre

St James’s University Hospital
LS9 7TF

Trial participating centre

Salford Royal Hospital
M6 8HD

Trial participating centre

North Manchester General Hospital
M8 5RB

Sponsor information

Organisation

Abbott Diabetes Care Ltd

Sponsor details

Range Road
Witney
OX29 0YL
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Diabetes Care Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 ADC_Witney_ClinicalAffairs@abbott.com.

Intention to publish date

31/07/2028

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal edit.