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
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