Performance review for FreeStyle Libre Glucose Monitoring Systems
| ISRCTN | ISRCTN83594795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83594795 |
| IRAS number | 292446 |
| Secondary identifying numbers | ADC-UK-PMS-20048, IRAS 292446 |
- Submission date
- 13/05/2021
- Registration date
- 28/06/2021
- Last edited
- 25/06/2021
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this study is to collect glucose data using the FreeStyle Libre Glucose Monitoring System from adults.
Who can participate?
Anyone aged 18 without diabetes or with type 1 or type 2 diabetes
What does the study involve?
Participants will wear up to four sensors for up to 14 days, after which sensors will be removed, and data uploaded. Each study event aims to recruit between 18 and 72 participants. Once a study event is complete another one commences, on a continuing basis. Each participant is in the study for up to 15 days.
What are the possible benefits & 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 from obtaining capillary blood samples, these are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
Abbott Diabetes Care (UK)
When is the study starting and how long is it expected to run for?
May 2020 to December 2031
Who is funding the study?
Abbott Diabetes Care (UK)
Who is the main contact?
Dr Pamela Reid
Contact information
Public
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| ADC.Clinical.Affairs.UK@abbott.com |
Study information
| Study design | Prospective single-arm single-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Sensor accuracy performance review for FreeStyle Libre Glucose Monitoring Systems |
| Study objectives | Accuracy of FreeStyle Libre Glucose Monitoring Systems compared to capillary fingerstick blood glucose values using the consensus error grid. |
| Ethics approval(s) | Approved 12/04/2021, West Midlands - South Birmingham Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8345, +44 (0)207 104 8107, +44 (0)207 104 8388; southbirmingham.rec@hra.nhs.uk), REC ref: 21/WM/0064 |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | Participants will wear up to four FreeStyle Libre Sensors for up to 14 days. There is no follow-up period unless the participant experiences an unanticipated adverse device effect (UADE). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre Sensors |
| Primary outcome measure | Accuracy of the FreeStyle Libre Glucose Monitoring Systems compared to capillary fingerstick blood glucose values (FreeStyle Optium blood glucose test strips) using the consensus error grid at the end of the sensor wear period |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/05/2020 |
| Completion date | 31/12/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 18-72 participants per study event |
| Key inclusion criteria | 1. Aged 18 years or over 2. Has type 1 or type 2 diabetes or has not been diagnosed as having diabetes 3. Be willing and able to test their blood glucose levels at least four times a day |
| Key exclusion criteria | 1. Has another form of diabetes e.g. maturity-onset diabetes of the young (MODY) 2. Have a known (or suspected) allergy to medical grade adhesive 3. Have a skin abnormality at the application sites 4. Have a pacemaker or any other neurostimulators 5. Have concomitant medical condition which in the participant’s opinion could interfere with the study or present a risk to their safety or welfare, or that of the study team |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 16/12/2031 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
witney
OX29 0YL
United Kingdom
Sponsor information
Industry
Range Road
witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| ADC.Clinical.Affairs.UK@abbott.com | |
| Website | http://www.abbott.co.uk/ |
"ROR" |
https://ror.org/03wnay029 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2032 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal. The estimated timeline is 1 year from the trial end date. No additional documents will be available at this stage. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of consent to share. All data will be held by Abbott Diabetes Care and used as part of a post-market surveillance program. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/05/2021: Trial's existence confirmed by the West Midlands - South Birmingham Research Ethics Committee.
