User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System
| ISRCTN | ISRCTN17191485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17191485 |
| Secondary identifying numbers | ADC-UK-PES-15027 |
- Submission date
- 16/07/2015
- Registration date
- 17/08/2015
- Last edited
- 15/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The FreeStyle Optium Blood Glucose Monitoring System is a system for measuring glucose levels and is freely available to buy on the market in the UK. The aim of the study is to evaluate whether at least 95% of FreeStyle Optium Blood Glucose Monitoring System results are required to be within ± 0.83 mmol/L (15mg/dL) / 15%.of the YSI reference measurement.
Who can participate?
Patients with diabetes and aged at least 16 years.
What does the study involve?
Participants first have an opportunity to familiarise themselves with the FreeStyle Optium System, before performing a blood glucose test from their fingertip. A capillary blood sample is collected to perform haemoglobin testing on the HemoCue analyser and a glucose reference test on the YSI analyser. This should take up no more than 30 minutes of each participants time.
What are the possible benefits and risks of participating?
There is no direct benefit to the participant by taking part in this study. The only risks associated with the study are capillary blood sample collection, these are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
The Ipswich Hospital NHS Trust and Leeds Teaching Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
July 2015 to October 2015
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
Study information
| Study design | Multi-centre prospective single arm |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System: a multi-centre prospective single arm study |
| Study objectives | The aim of the study is to evaluate whether at least 95% of FreeStyle Optium Blood Glucose Monitoring System results are required to be within ± 0.83 mmol/L (15mg/dL) / 15%.of the YSI reference measurement. |
| Ethics approval(s) | NRES Committee South Central - Berkshire B, 23/06/2015, ref: 15/SC/0395 |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | 1. A participant will perform a blood glucose measurement on the FreeStyle Optium Blood Glucose Monitoring System 2. A capillary blood sample will be collected to perform haemoglobin testing on the HemoCue analyser and a glucose reference test on the YSI analyser |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Accuracy analysis will be performed according to ISO 15197:2013 Section 8.2 The analysis will be performed when the study is complete. ISO 15197:20131 section 8.2 specifies that at least 95% of fingerstick blood glucose results are required to be within ± 0.83 mmol/L (15mg/dL) / 15% of the reference analyser (YSI). Regression analysis will also be performed and plots of the data will be generated. |
| Secondary outcome measures | Linear regression and error grid analysis. |
| Overall study start date | 27/07/2015 |
| Completion date | 30/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 participants |
| Total final enrolment | 165 |
| Key inclusion criteria | 1. Type 1 or Type 2 Diabetes 2. Age ≥ 16 years |
| Key exclusion criteria | 1. Currently using the FreeStyle Optium, Boots or Optium Xceed Blood Glucose Monitoring System for routine testing at home (as pictured in the PIIC) 2. Known to be infected with hepatitis B virus (Hep B), hepatitis C virus (Hep C) or human immunodeficiency virus (HIV) 3. Be a member of the study staff 4. Already participated in this study |
| Date of first enrolment | 27/07/2015 |
| Date of final enrolment | 11/09/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
IP4 5PD
United Kingdom
LS9 7TF
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 | 01/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results of these studies are rarely of interest to scientific or medical publications but we will submit to an appropriate journal or meeting in 2016. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Funder report results | Abbott white paper | 01/01/2016 | 15/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/08/2022: Funder report moved to trial outputs from publication and dissemination plan.
03/07/2020: The following changes have been made:
1. Funder report added to the publication and dissemination plan.
2. The total final enrolment number has been added from the reference.
21/12/2017: No publications found, verifying study status with principal investigator.
