Blood Ketone Performance Test
| ISRCTN | ISRCTN13235081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13235081 |
| IRAS number | 142273 |
| Secondary identifying numbers | PMS-KET-004 |
- Submission date
- 21/02/2019
- Registration date
- 28/02/2019
- Last edited
- 15/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and 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 2035
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
Contact information
Public
Range Road, Witney
Witney
OX29 0YL
United Kingdom
| Phone | Range Road, Witney |
|---|---|
| Pamela.reid@abbott.com |
Study information
| Study design | Multi-centre open-label prospective single arm |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Blood Ketone Performance Test |
| Study hypothesis | Current study hypothesis as of 15/04/2025: To collect data from blood ketone monitoring systems by comparing whole blood results obtained using the blood ketone monitoring system to plasma measurements obtained by a laboratory reference method. Previous study hypothesis: Assess the accuracy of blood ketone monitoring systems by comparing results to plasma measurements obtained by a laboratory reference method. |
| Ethics approval(s) |
Approved 03/01/2016, North West – Greater Manchester (GM) East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)2071048290; gmeast.rec@hra.nhs.uk), ref: 04/Q1401/15 |
| Condition | Patients with potential ketosis, including diabetes patients and those presenting with diabetic ketoacidosis (DKA) |
| Intervention | Current interventions as of 15/04/2025: Participants will provide a venous or capillary blood sample that will be tested on the blood ketone monitoring system/s. Participants, particularly those with DKA, can continue to provide samples until their ketone levels return to normal levels. For any inpatients, participation will cease prior to hospital discharge. Previous interventions: 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Blood ketone monitoring systems |
| Primary outcome measure | Current primary outcome measure as of 15/04/2025: The results from blood ketone monitoring systems will be compared to plasma measurements obtained by a laboratory reference method using Bland-Altman analysis. Previous 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 study start date | 01/10/2015 |
| Overall study end date | 30/09/2035 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | The target is to obtain at least 50 samples and up to 300 samples per year. Each participant can consent to give repeated blood samples until ketone levels return to normal. |
| Participant inclusion criteria | 1. Any potentially ketotic person. 2. ≥16 years of age. |
| 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 | 30/09/2035 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
LS9 7TF
United Kingdom
M8 5RB
United Kingdom
Sponsor information
Industry
Range Road, Witney
Witney
OX29 0YL
United Kingdom
| Phone | +44 1993 863164 |
|---|---|
| Pamela.reid@abbott.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2036 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Pamela Reid. |
Editorial Notes
15/04/2025: The following changes were made:
1. IRAS number added.
2. The study hypothesis, interventions, primary outcome measure were updated.
3. Ethics committee details were updated.
4. The study design was changed from "Multi-centre prospective single arm" to "Multi-centre open-label prospective single arm".
5. The overall study end date was changed from 30/09/2025 to 30/09/2035.
6. The condition "Diabetes" was updated to "Patients with potential ketosis, including diabetes patients and those presenting with diabetic ketoacidosis (DKA)".
7. The pharmaceutical study type(s), phase, and drug/device/biological/vaccine name(s) were added.
8. The target number of participants was changed from "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.".
9. The recruitment end date was changed from 30/09/2025 to 30/09/2035.
10. The study participating centre, Salford Royal Hospital, was removed.
11. The intention to publish date was changed from 30/09/2026 to 30/09/2036.
12. The Sponsor email address was changed, and the Funder was defined as in the UK, not the USA.
28/02/2019: Trial's existence confirmed by the North West - Greater Manchester East Research Ethics Committee.
