Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/11/2014
Date assigned
27/01/2015
Last edited
27/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Gerry Rayman

ORCID ID

Contact details

The Diabetes Centre
The Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom

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

Sponsor information

Organisation

Abbott Diabetes Care Ltd (UK)

Sponsor details

c/o Joe Bugler
Range Road
Witney
OX29 0YL
United Kingdom

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes