Performance check and safety data collection of FreeStyle Libre Glucose Monitoring Systems
| ISRCTN | ISRCTN87654534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87654534 |
| IRAS number | 161804 |
| Secondary identifying numbers | ADC-UK-PMS-14020, IRAS Project ID: 161804 |
- Submission date
- 13/02/2015
- Registration date
- 16/03/2015
- Last edited
- 26/09/2022
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The FreeStyle Libre Flash Glucose Monitoring System is a new system for measuring glucose levels and is CE marked and marketed within the UK. The aim of this study is to evaluate the accuracy of the system for people with diabetes, especially those who take insulin.
Who can participate?
Adults aged 18 and over who have type 1 or 2 diabetes.
What does the study involve?
Participants wear the three Sensors according to labelling instructions. The data is transferred and stored in the Reader memory by regular scanning of the Sensor by the participants. Each study event aims to recruit between 18 and 36 participants across approximately 12 sites. Once a study event is complete another one commences, on a continuing basis. Each participant is in the study for up to 15 days. Participants wear a FreeStyle Libre Flash Glucose Monitoring System for 14 days while going about their daily activities. Participants perform four BG fingerstick readings per day for each day of Sensor wear using the built-in test strip port in the Reader to allow evaluation of Sensor accuracy. During Visit 1 participants provide demographic data, and their height and weight are recorded. Participants are trained on how to use the FreeStyle Libre Flash Glucose Monitoring System. They are also instructed to scan the Sensor with the Reader immediately after they do a fingerstick test. Participants return to the clinic on day 15 where their Sensors are scanned before removal and the data is uploaded. This is the end of their study participation. The data is subsequently analysed at Abbott Diabetes Care.
What are the possible benefits and risks of participating?
This study gives participants the opportunity to use flash glucose monitoring as a way of managing their diabetes, which may be of benefit. There are risks associated with the use of any device that punctures the skin. FreeStyle Libre Flash Glucose Monitoring System uses a delivery applicator that places the Sensor ½ cm (or 1/5 inch) into the skin. The participant may experience some mild or moderate symptoms associated with the Sensor insertion or the adhesive used to keep the Sensor in place. These include redness, swelling, rash, itching, bruising, pain and bleeding. Blood glucose testing on the Reader may require a few drops (less than 1/100 teaspoon) of blood per day. The risks are the same as the participants' current blood glucose testing. It may hurt when the lancet goes into the skin; this could produce bruising and a small scar, which could last for several weeks plus there is a low risk of infection. There are similar small risks with the collection of a blood sample for the HbA1c blood test, plus possible dizziness. The amount of blood taken for this test (if one is required) will be up to about 1-2 teaspoons.
Where is the study run from?
Six hospitals in the UK: Oxford Centre for Diabetes, Endocrinology and metabolism (OCDEM), Oxford, The Ipswich Hospital, Ipswich, North Manchester General Hospital, Crumpsall, Royal United Hospital, Bath, Royal Cornwall Hospital, Truro and St James Hospital, Leeds.
When is the study starting and how long is it expected to run for?
January 2015 to December 2027 (updated 17/07/2019, previously: 2026)
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 (0)1993 863101 |
|---|---|
| pamela.reid@abbott.com |
Study information
| Study design | Multi-centre (12 UK sites) prospective open single-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Performance check and safety data collection of FreeStyle Libre Glucose Monitoring Systems |
| Study hypothesis | The aim of this study is to evaluate the accuracy of the Abbott FreeStyle Libre Flash Glucose Monitoring System, designed for testing of blood glucose for people with diabetes, especially those who take insulin. |
| Ethics approval(s) | NRES Committee West Midlands - South Birmingham, 17/11/2014, ref: 14/WM/1136 |
| Condition | Diabetes mellitus |
| Intervention | Current interventions as of 26/09/2022: Participants wear the three Sensors according to labelling instructions. The data is transferred and stored in the Reader memory by regular scanning of the Sensor by the participants. Each study event aims to recruit between 18 and 36 participants across approximately 12 sites. Once a study event is complete another one commences, on a continuing basis. Each participant is in the study for up to 15 days. Participants wear a FreeStyle Libre Flash Glucose Monitoring System for 14 days while going about their daily activities. Participants perform four BG fingerstick readings per day for each day of Sensor wear using the built-in test strip port in the Reader to allow evaluation of Sensor accuracy. During Visit 1 participants provide demographic data, and their height and weight are recorded. Participants are trained on how to use the FreeStyle Libre Flash Glucose Monitoring System. They are also instructed to scan the Sensor with the Reader immediately after they do a fingerstick test. Participants return to the clinic on day 15 where their Sensors are scanned before removal and the data is uploaded. This is the end of their study participation. The data is subsequently analysed at Abbott Diabetes Care. _____ Previous interventions: Participants wear the two Sensors according to labelling instructions. The data is transferred and stored in the Reader memory by regular scanning of the Sensor by the participants. Each study event aims to recruit between 18 and 36 participants across approximately six sites. Once a study event is complete another one commences, on a continuing basis. Each participant is in the study for up to 15 days. Participants wear a FreeStyle Libre Flash Glucose Monitoring System for 14 days while going about their daily activities. Participants perform four BG fingerstick readings per day for each day of Sensor wear using the built-in test strip port in the Reader to allow evaluation of Sensor accuracy. During Visit 1 participants provide demographic data, their height and weight is recorded. Participants are trained on how to use the FreeStyle Libre Flash Glucose Monitoring System. They are also instructed to scan the Sensor with the Reader immediately after they do a fingerstick test. Participants return to the clinic on day 15 where their Sensors are scanned before removal and the data is uploaded. This is the end of their study participation. The data is subsequently be analysed at Abbott Diabetes Care. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre Flash Glucose Monitoring System |
| 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. For all primary and secondary outcomes, the data is generated during the Sensor wear period (up to 14 days) during which the participant measures their blood glucose (BG) at least 4 times a day with corresponding Sensor scans. The data recorded in the Reader will be uploaded at visit 2 (day 15) and subsequently transferred to Abbott Diabetes Care (ADC) for analysis. The primary outcome will be measured by calculating the proportion of paired Sensor and BG values within each zone of the Consensus Error Grid. |
| Secondary outcome measures | 1. Precision within Sensor lot estimated by calculating the coefficient of variation of Sensor slopes. Slopes will be calculated for each sensor by standard linear regression of Sensor Glucose vs. BG 2. Relationship between HbA1c levels and glycaemic variability, determined from Sensor glucose values For all primary and secondary outcomes, the data is generated during the Sensor wear period (up to 14 days) during which the participant measures their blood glucose (BG) at least 4 times a day with corresponding Sensor scans. The data recorded in the Reader will be uploaded at visit 2 (day 15) and subsequently transferred to Abbott Diabetes Care (ADC) for analysis |
| Overall study start date | 13/01/2015 |
| Overall study end date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Each study event will aim to recruit between 18 and 36 participants. A minimum of 360 participants will be recruited per year, with the protocol end date in December 2026, there will be up to 3600 participants recruited in this study protocol |
| Participant inclusion criteria | 1. Aged 18 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 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 | 23/01/2014 |
| Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Crumpsall
Manchester
M8 5RB
United Kingdom
United Kingdom
United Kingdom
Avon
BA1 3NG
United Kingdom
Treliske
Truro
TR1 3LQ
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 7NT
United Kingdom
"ROR" |
https://ror.org/03wnay029 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Following study completion, results are expected to be submitted for publication. The purpose of this study is to monitor the ongoing analytical performance of the FreeStyle Libre Flash Glucose Monitoring System as part of a post-market surveillance program and therefore would be published as such in accordance with the primary/secondary endpoints described. |
| IPD sharing plan | - |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/09/2022: The following changes have been made and the plain English summary updated accordingly:
1. The public title has been changed from "Performance Check of the Abbott FreeStyle Libre Flash Glucose Monitoring System" to “Performance check and safety data collection of FreeStyle Libre Glucose Monitoring Systems”.
2. The scientific title has been changed from "Performance Check of the Abbott FreeStyle Libre Flash Glucose Monitoring System: a multi-centre prospective open single arm study" to "Performance check and safety data collection of FreeStyle Libre Glucose Monitoring Systems".
3. The interventions have been updated.
4. The study design was updated from "Multi-centre (six UK sites) prospective open single-arm study" to "Multi-centre (12 UK sites) prospective open single-arm study".
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 22/12/2026 to 31/12/2026.
2. The overall end date was changed from 22/12/2026 to 31/12/2027.
3. The intention to publish date was added.
4. The plain English summary was updated to reflect these changes.
08/02/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 22/12/2024 to 22/12/2026.
2. The recruitment end date was changed from 22/12/2024 to 22/12/2026.
2. The target number of participants was changed from 'Each study event will aim to recruit 36 participants (30 minimum). Ten study events can occur per year, therefore, a total of up to 360 participants will be recruited per year, with the protocol end date in December 2024, there will be up to 3600 participants recruited in this study protocol' to 'Each study event will aim to recruit between 18 and 36 participants. A minimum of 360 participants will be recruited per year, with the protocol end date in December 2026, there will be up to 3600 participants recruited in this study protocol'.
4. Royal South Hants Hospital was removed and North Manchester General Hospital, Royal United Hospital, Royal Cornwall Hospital, and St James Hospital were added to the trial participating centres.
