Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/12/2019
Date assigned
20/12/2019
Last edited
27/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of diabetes mellitus. DKA is typically diagnosed when testing finds high blood sugar, low blood pH and ketones (including β-hydroxybutyrate) in either the blood or urine. Ketones are substances that your body makes if your cells don't get enough glucose (blood sugar).
The aim of this study is to evaluate the difference between blood β-hydroxybutyrate levels in blood that is flowing away from the heart and flowing towards the heart (after it has passed through tissues).

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

What does the study involve?
The participant will give a blood sample by venepuncture (the puncture of a vein) or by a fingerprick and the blood will be tested on the reference method as plasma.
Participants can give a maximum of four blood samples until ketone levels return to normal. Participation in this study will cease prior to hospital discharge.

What are the possible benefits & risks of participating?
There is no direct benefit to the participant taking part in this study. 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. John Radcliffe Hospital, Oxford, UK
2. Royal Surrey County Hospital, Guildford, UK
3. Royal United Hospitals, Bath, UK
4. Royal Cornwall Hospital, Truro, UK
5. Royal Infirmary, Edinburgh, UK

When is the study starting and how long is it expected to run for?
September 2019 to September 2020

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

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
OX29 0YL
United Kingdom
+44 (0)1993 863024
Pamela.Reid@abbott.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ADC-UK-RES-19045; IRAS 275338

Study information

Scientific title

Laboratory evaluation of β-hydroxybutyrate levels in capillary and venous blood

Acronym

Study hypothesis

This study is being conducted to determine the difference in β-hydroxybutyrate levels in capillary and venous blood, sampled concurrently from people in diabetic ketoacidosis (DKA) or with ketosis.

Ethics approval

Approved 26/11/2019, NRES Committee: London - City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8033; nrescommittee.london-cityandeast@nhs.net), ref: 19/LO/1919

Study design

Prospective multi-centre single-arm study in hospital settings

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Diabetic ketoacidosis or ketosis

Intervention

Participants will have venous and capillary blood collected, which may be repeated:
- A maximum of 4 times
- Or, until ketone levels return to normal
- Or, participants are discharged from hospital

Intervention type

Other

Phase

Drug names

Primary outcome measure

Capillary blood β-hydroxybutyrate levels and venous blood β-hydroxybutyrate levels as measured on the Randox Ranbut laboratory reference method using Bland-Altman analysis at each visit

Secondary outcome measures

None

Overall trial start date

01/09/2019

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 16 years or over
2. Potentially ketotic, or in diabetic ketoacidosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35

Participant exclusion criteria

1. Already participated in this study
2. Concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff
3. Infected with hepatitis B virus (Hep B), hepatitis C virus (Hep C), or human immunodeficiency virus (HIV)

Recruitment start date

06/01/2020

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Royal Surrey County Hospital
Guildford
GU2 7XX
United Kingdom

Trial participating centre

Royal United Hospitals
Bath
BA1 3NG
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Truro
TR1 3LJ
United Kingdom

Trial participating centre

Royal Infirmary
Edinburgh
EH16 4TJ
United Kingdom

Sponsor information

Organisation

Abbott (United Kingdom)

Sponsor details

Range Road
Witney
OX29 0YL
United Kingdom
+44 (0)1993 863024
Pamela.Reid@abbott.com

Sponsor type

Industry

Website

http://www.abbott.co.uk/

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 study will be available upon request from Pamela Reid (Pamela.Reid@abbott.com).

Intention to publish date

30/09/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/08/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/08/2020 to 30/09/2020. 2. The overall end date was changed from 31/08/2020 to 30/09/2020. 3. The intention to publish date was changed from 31/08/2021 to 4. The plain English summary was updated to reflect these changes. 08/07/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 30/06/2020 to 31/08/2020. 2. The overall end date was changed from 30/06/2020 to 31/08/2020. 3. The intention to publish date was changed from 30/06/2021 to 31/08/2021. 4. The plain English summary was updated to reflect these changes. 07/04/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/03/2020 to 30/06/2020. 2. The overall end date was changed from 31/03/2020 to 30/06/2020. 3. The intention to publish date was changed from 31/03/2021 to 30/06/2021. 4. The plain English summary was updated to reflect these changes. 12/03/2020: The following changes have been made: 1. The recruitment end date has been changed from 28/02/2020 to 31/03/2020. 2. The overall trial end date has been changed from 28/02/2020 to 31/03/2020. 3. The intention to publish date has been changed from 28/02/2021 to 31/03/2021. 4. The plain English summary has been updated to reflect the changes above. 19/12/2019: Trial's existence confirmed by London - City & East Research Ethics Committee.