Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/07/2015
Date assigned
17/08/2015
Last edited
08/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The FreeStyle Libre sensor automatically measures blood glucose levels around the clock, and stores the data for later retrieval. The aim of this study is to assess the accuracy of this device compared with blood glucose strips for patients with type 1 and type 2 diabetes.

Who can participate?
Aged at least 18 with diabetes (type 1 or type 2).

What does the study involve?
All participants wear up to 3 masked FreeStyle Libre Flash Glucose Monitoring System for 14 days while going about their daily activities. That is, they wear the sensor according to labelling instructions but are not able to see any sensor glucose data, unless they choose to wear an optional sensor (unmasked). The data collected is transferred and stored in the reader memory by regular scanning of the sensor by the participants. Participants also perform four fingerstick readings per day, using the built-in blood glucose test strip port in the device’s reader. These blood glucose strip results are visible to the patient throughout. During visit 1 to their trial participating clinic, each participant’s demographic data, height and weight is recorded and their HbA1c result obtained. Participants are then be trained on how to use the FreeStyle Libre Flash Glucose Monitoring System and instructed to scan the sensor with the reader immediately after they do a fingerstick test. Three to five days later a follow up phone call is made to check that participants have not had any issues. Participants return to the clinic on day 15 where their sensors are scanned prior to removal and the data uploaded. This is the end of their study participation. The data is subsequently analysed.

What are the possible benefits and risks of participating?
There may be no direct benefit to the participant by wearing the masked device. However, if the participant takes the option of wearing a second unmasked Sensor they can use this to manage their diabetes. Some participants may experience either mild or moderate symptoms associated with the sensor placement on the skin as this is attached by means of a medical grade adhesive. To minimize the risk of reactions, participants will be asked if they have a known allergy to medical grade adhesives prior to enrolment and checked at each visit.

Where is the study run from?
1. Ipswich Hospital NHS Trust (UK)
2. Oxford University Hospitals NHS Trust (UK)
3. North Manchester General Hospital, Crumpsall (UK)
4. The Royal United Hospital, Bath (UK)
5. The Royal Cornwall Hospital, Truro (UK)
6. St James Hospital, Leeds (UK)

When is the study starting and how long is it expected to run for?
July 2015 to January 2017

Who is funding the study?
Abbott Diabetes Care Ltd (UK)

Who is the main contact?
Dr Pamela Reid

Trial website

Contact information

Type

Public

Primary contact

Dr Pamela Reid

ORCID ID

Contact details

Range Road
Witney
OX29 0YL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADC-UK-PMS-14021

Study information

Scientific title

Masked performance check of the Abbott FreeStyle Libre Flash Glucose Monitoring System: an interventional trial

Acronym

Study hypothesis

The aim of this study is to evaluate the accuracy and performance of the masked Abbott FreeStyle Libre Flash Glucose Monitoring System

Ethics approval

NRES Committee North West - Lancaster, 20/03/2015, ref: 15/NW/0267

Study design

Multi-centre prospective single arm

Primary study design

Interventional

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Diabetes mellitus

Intervention

Interventions as on 08/02/2017:
1. Participants will wear up to 3 Masked FreeStyle Libre Glucose Monitoring Sensor for up to 14 days. Participants have an option to experience the use ofan unmasked FreeStyle Libre Glucose Monitoring Sensor
2. Participants will also perform between 4 and 8 fingerstick readings per day for each day of sensor wear using the built-in test strip port

Original interventions section:
1. Participants will wear a Masked FreeStyle Libre Glucose Monitoring Sensor for 14 days, at the same time participants have an option to wear a second unmasked FreeStyle Libre Glucose Monitoring Sensor
2. Participants will also perform four fingerstick readings per day for each day of sensor wear using the built-in test strip port

Intervention type

Device

Phase

Drug names

Primary outcome measures

Accuracy performance of the Abbott FreeStyle Libre Flash Glucose Monitoring System compared to capillary fingerstick blood glucose values (FreeStyle Optium blood glucose test strips) using the consensus error grid.

Secondary outcome measures

Precision within Sensor lot.

Overall trial start date

20/07/2015

Overall trial end date

31/01/2027

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Have type 1 or type 2 diabetes
3. Be self-testing their blood glucose levels at least twice per day
4. Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol, in the investigator’s opinion
5. Be available for all study visits
6. Be willing to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12 to 36 participants per sensor lot, with up to three sensor lots tested per study event.

Participant exclusion criteria

1. Participated in the same study event
2. Be a member of the study staff
3. Have a known allergy to medical grade adhesive
4. Be pregnant or planning to become pregnant within the study event duration
5. Have skin abnormality at the application sites
6. Have a pacemaker or any other neuro stimulators
7. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff

Recruitment start date

20/07/2015

Recruitment end date

21/07/2026

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Trust
Oxford
OX3 9DU
United Kingdom

Trial participating centre

North Manchester General Hospital
Delaunays Road Crumpsall
Manchester
M8 5RB
United Kingdom

Trial participating centre

Royal United Hospital Bath
Combe Park Avon
Bath
BA1 3NG
United Kingdom

Trial participating centre

Royal Cornwall Hospital
2 Penventinnie Lane Treliske
Truro
TR1 3LQ
United Kingdom

Trial participating centre

St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Abbott Diabetes Care Ltd

Sponsor details

Range Road
Witney
OX29 0YL
United Kingdom

Sponsor type

Industry

Website

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

The primary device in the study is not being used in the same way as its on market intended use, (i.e. the sensor results are masked to the subject.) Therefore the findings from the study are of negligible value to the medical or scientific community and so it is challenging to publish. If the results highlight any interesting information we will consider specifically preparing a manuscript or abstract to report this.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/02/2017: The overall trial end date has been updated from 21/07/2025 to 31/01/2027 and the recruitment end date has been updated from 21/07/2015 to 21/07/2016. In addition, three trial participating centres have been added and the interventions section has been updated and the target number of participants has been updated from 36 to 108. The plain English summary has also been updated to reflect these changes.