User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System

ISRCTN	ISRCTN17191485
DOI	https://doi.org/10.1186/ISRCTN17191485
Protocol serial number	ADC-UK-PES-15027
Sponsor	Abbott Diabetes Care
Funder	Abbott Diabetes Care Ltd

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Pamela Reid
Public

Range Road
Witney
OX29 0YL
United Kingdom

Study information

Primary study design	Interventional
Study design	Multi-centre prospective single arm
Secondary study design
Study type	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
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Linear regression and error grid analysis.
Completion date	30/10/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
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

United Kingdom
England

Study participating centres

The Ipswich Hospital NHS Trust

Ipswich
IP4 5PD
United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.