Masked performance check of the Abbott FreeStyle Libre Flash Glucose Monitoring System
| ISRCTN | ISRCTN12543702 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12543702 |
| IRAS number | 178494 |
| Secondary identifying numbers | ADC-UK-PMS-14021, IRAS 178494 |
- Submission date
- 16/07/2015
- Registration date
- 17/08/2015
- Last edited
- 20/12/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
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?
Patients aged at least 18 years 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 up to 14 days while going about their daily activities. That is, they wear the sensor according to labelling instructions but cannot 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 between four and eight 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 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)
7. St Georges Hospital (UK)
8. Frimley Park Hospital (UK)
9. Royal Surrey County Hospital (UK)
10. MAC Clinical Research Centre (UK)
When is the study starting and how long is it expected to run for?
July 2015 to March 2027
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
| Phone | +44 1993 863024 |
|---|---|
| pamela.reid@abbott.com |
Study information
| Study design | Multi-centre prospective single arm |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Hospital, Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Masked performance check of the Abbott FreeStyle Libre Flash Glucose Monitoring System: an interventional trial |
| 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(s) | NRES Committee North West - Lancaster, 20/03/2015, ref: 15/NW/0267 |
| 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre |
| Primary outcome measure | 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 study start date | 20/07/2015 |
| Overall study end date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 to 36 participants per sensor lot, with up to 12 sensor lots tested per study event |
| 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 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 | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
IP4 5PD
United Kingdom
OX3 9DU
United Kingdom
Crumpsall
Manchester
M8 5RB
United Kingdom
Avon
Bath
BA1 3NG
United Kingdom
Treliske
Truro
TR1 3LQ
United Kingdom
Leeds
LS9 7TF
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Frimley
GU16 7UJ
United Kingdom
Guildford
GU2 7XX
United Kingdom
Blackpool
FY2 0JH
United Kingdom
Nelson St
Manchester
M13 9NQ
United Kingdom
Sabatier Close
Stockton-on-Tees
TS17 6EW
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 1993 863024 |
|---|---|
| pamela.reid@abbott.com | |
"ROR" |
https://ror.org/03wnay029 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/12/2023: The following changes were made:
1. IRAS number added.
2. Study participating centre East Surrey Hospital was removed.
3. Study participating centres MAC Clinical Research Manchester and MAC Clinical Research Teesside were added.
4. Device name was added.
21/03/2023: The target number of participants was changed from '12 to 36 participants per sensor lot, with up to three sensor lots tested per study event' to '12 to 36 participants per sensor lot, with up to 12 sensor lots tested per study event'. MAC Blackpool was added to the trial participating centres.
06/10/2020: The sponsor contact details have been changed.
29/09/2020: The following trial participating centres were added: St George's University Hospital, Frimley Park Hospital, Royal Surrey County Hospital, East Surrey Hospital.
09/07/2020: The trial contact details have been made publicly visible.
17/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 21/07/2026 to 31/03/2026.
2. The overall end date was changed from 31/01/2027 to 31/03/2027.
3. The intention to publish date was added.
4. The plain English summary was updated to reflect these changes.
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.
