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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ADC-UK-PES-15027
Study information
Scientific title
User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System: a multi-centre prospective single arm study
Acronym
Study hypothesis
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
NRES Committee South Central - Berkshire B, 23/06/2015, ref: 15/SC/0395
Study design
Multi-centre prospective single arm
Primary study design
Interventional
Secondary study design
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
27/07/2015
Overall trial end date
30/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type 1 or Type 2 Diabetes
2. Age ≥ 16 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 participants
Total final enrolment
165
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
27/07/2015
Recruitment end date
11/09/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom
Trial participating centre
Leeds Teaching Hospitals NHS Trust
Leeds
LS9 7TF
United Kingdom
Funders
Funder type
Industry
Funder name
Abbott Diabetes Care Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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.
2016 results in https://freestylediabetes.co.uk/images/uploads/documents/White_Paper__Clinical_FreeStyle_Optium_Neo.pdf (added 03/07/2020)
Intention to publish date
01/07/2016
Participant level data
Available on request
Basic results (scientific)
Publication list