Plain English Summary
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
User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System: a multi-centre prospective single arm study
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.
NRES Committee South Central - Berkshire B, 23/06/2015, ref: 15/SC/0395
Multi-centre prospective single arm
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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
Primary outcome measures
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 trial start date
Overall trial end date
Participant inclusion criteria
1. Type 1 or Type 2 Diabetes
2. Age ≥ 16 years
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Ipswich Hospital NHS Trust
Trial participating centre
Leeds Teaching Hospitals NHS Trust
Abbott Diabetes Care Ltd
Funding Body Type
Funding Body Subtype
Results and Publications
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
Intention to publish date
Participant level data
Available on request
Results - basic reporting