Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/02/2019
Date assigned
28/02/2019
Last edited
27/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background & study aims
The aim of this study is to monitor the performance of blood ketone monitoring systems (blood ketone meters and test strips) designed for people with diabetes to test their blood ketone levels.

Who can participate?
Patients aged 16 and over who are potentially ketotic

What does the study involve?
The participant will give a blood sample either by venepuncture (the puncture of a vein) or by a fingerprick and the blood will be tested on the blood ketone monitoring system as whole blood and on the reference method as plasma.

Participants can consent to give repeated blood samples until ketone levels return to normal. Participation in this study will cease prior to hospital discharge for participants providing samples at multiple time points.

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 ketone 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?
St James’s University Hospital, Leeds, Salford Royal Hospital, Salford & North Manchester General Hospital, Manchester

When is the study starting and how long is it expected to run for?
January 2016 to September 2025

Who is funding the study?
The study is funded by Abbott Diabetes Care Ltd

Who is the main contact?
Dr Pamela Reid
Pamela.reid@abbott.com

Trial website

Contact information

Type

Public

Primary contact

Dr Pamela Reid

ORCID ID

Contact details

Range Road
Witney
Witney
OX29 0YL
United Kingdom
Range Road, Witney
Pamela.reid@abbott.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PMS-KET-004

Study information

Scientific title

Blood Ketone Performance Test

Acronym

Study hypothesis

Assess the accuracy of blood ketone monitoring systems by comparing results to plasma measurements obtained by a laboratory reference method.

Ethics approval

Approved 03/01/2016, NRES Committee: North West – Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ; nrescommittee.northwest-gmeast@nhs.net; 0207 104 8196), ref: 04/Q1401/15.

Study design

Multi-centre, prospective, single arm

Primary study design

Other

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Diabetes

Intervention

Participants will provide a venous or capillary blood sample that will be tested on the blood ketone monitoring system until their ketone levels return to normal levels. For any in-patients, participation will cease prior to hospital discharge.

Intervention type

Device

Phase

Drug names

Primary outcome measure

The accuracy performance of the blood ketone monitoring system compared to plasma measurements obtained by a laboratory reference method by using the Bland-Altman plot.

Secondary outcome measures

Blood samples will be used to compare results obtained on the blood ketone monitoring systems (y) with plasma results obtained on the reference system (x) by performing linear regression analysis (y vs. x). The slope, intercept, correlation coefficient, and confidence intervals for the slope and intercept will be calculated.

Overall trial start date

01/10/2015

Overall trial end date

30/09/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Any potentially ketotic person.
2. ≥16 years of age.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The target is to obtain at least 50 samples per lot and up to 250 samples per year. Each participant can consent to give repeated blood samples until ketone levels return to normal.

Participant exclusion criteria

1. Known to be infected with hepatitis B virus (Hep B), hepatitis C virus (Hep C) or human immunodeficiency virus (HIV).
2. Member of the study staff.

Recruitment start date

18/04/2016

Recruitment end date

30/09/2025

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James’s University Hospital
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Salford Royal Hospital
Salford
M6 8HD
United Kingdom

Trial participating centre

North Manchester General Hospital
Crumpsall
M8 5RB
United Kingdom

Sponsor information

Organisation

Abbott Diabetes Care Ltd

Sponsor details

Range Road
Witney
Witney
OX29 0YL
United Kingdom
+44 1993 863164
Joe.bugler@abbott.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Diabetes Care

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal. Estimated timeline is one year from trial end date.

IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from Pamela Reid.

Intention to publish date

30/09/2026

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/02/2019: Trial's existence confirmed by the North West - Greater Manchester East Research Ethics Committee.