Blood glucose performance test
| ISRCTN | ISRCTN11379850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11379850 |
| Secondary identifying numbers | ADC-UK-PMS-16030 |
- Submission date
- 10/02/2017
- Registration date
- 12/05/2017
- Last edited
- 09/07/2020
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar (glucose) level to become too high. The aim of this study is to monitor the performance of blood glucose monitoring systems (blood glucose meters and test strips) designed for people with diabetes to test their blood glucose.
Who can participate?
Patients aged 16 and over with diabetes
What does the study involve?
Participation for the patient consists of one visit to the study site. The visit is expected to last about 5 to 20 minutes. The participant gives a blood sample either by venepuncture (the puncture of a vein) or by a fingerprick and the blood is tested using both the blood glucose monitoring system and the reference method. The accuracy and precision of the methods are compared.
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 glucose 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?
1. Ipswich Hospital (UK)
2. Oxford Centre for Diabetes, Endocrinology and Metabolism (UK)
3. St James’s University Hospital (UK)
4. Salford Royal Hospital (UK)
5. North Manchester General Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2017 to December 2029 (updated 16/07/2019, previously: July 2027)
Who is funding the study?
Abbott Diabetes Care Ltd (UK)
Who is the main contact?
Dr Pamela Reid
Contact information
Public
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| Pamela.reid@abbott.com |
Study information
| Study design | Multi-centre prospective single-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Blood glucose performance test: a multi-centre prospective single-arm study |
| Study objectives | Assess the accuracy of blood glucose monitoring systems using capillary blood samples according to ISO 15197 and venous blood samples using the Consensus Error Grid. |
| Ethics approval(s) | NRES Committee: London – Westminster Research Ethics Committee, 22/12/2016, ref: 16/LO/2217 |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | Whole blood obtained from the subject (venous whole blood from venepuncture or capillary whole blood from a fingerstick) will be tested on the blood glucose monitoring systems, the HemoCue analyser and the YSI analyser. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. The accuracy of the blood glucose monitoring system compared to the YSI analyser using fingerstick capillary or venous whole blood samples: 1.1. Capillary: Percentage of replicates within ISO15197 2003 or 2015 system accuracy criteria 1.2. Venous: Percentage of responses within each zone of the Consensus Error Grid Measured at the single study visit |
| Secondary outcome measures | 1. Precision: Mean paired replicate coefficient of variation (Capillary/Venous) 2. Error grid analysis: Percentage of replicates within each zone of the Consensus Error Grid (Capillary) Measured at the single study visit |
| Overall study start date | 01/02/2017 |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | The target is to enroll approximately 55 participants per study event |
| Key inclusion criteria | 1. Diagnosed with diabetes 2. ≥16 years of age |
| Key exclusion criteria | 1. Participated in the study event already 2. Member of the site study team |
| Date of first enrolment | 01/02/2017 |
| Date of final enrolment | 31/12/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
"ROR" |
https://ror.org/03wnay029 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The purpose of this study is to monitor ongoing performance as part of a post-market surveillance program. Results are of limited interest to scientific or medical publications, however if the results highlight any interesting information a manuscript or abstract will be prepared. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from ADC_Witney_ClinicalAffairs@abbott.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/07/2020: The trial contact details have been made publicly visible.
16/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2026 to 31/12/2028.
2. The overall end date was changed from 31/07/2027 to 31/12/2029.
3. The intention to publish date was changed from 31/07/2028 to 31/12/2030.
4. The plain English summary was updated to reflect these changes.
12/07/2017: Internal edit.
