Assessing the use of FreeStyle Libre Pro with HbA1c in diabetes management
| ISRCTN | ISRCTN36033130 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36033130 |
| Secondary identifying numbers | ADC-UK-PMS-19044 |
- Submission date
- 11/10/2019
- Registration date
- 14/10/2019
- Last edited
- 21/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background & study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this pilot study is to collect glucose data using the FreeStyle Libre Pro Flash Glucose Monitoring System from adults with type 2 diabetes on oral glucose-lowering medication, with or without biphasic insulin
Who can participate?
Patients aged 18 and over with type 2 diabetes on oral glucose-lowering medication, or, oral glucose-lowering medication and biphasic insulin
What does the study involve?
Participants will wear two sensors for up to 14 days (glucose data is not visible during this time). Participants will return to the clinic where the sensors will be removed, and data uploaded
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 venous blood samples, these are small but could include pain, bruising, local infection and fainting. Data collected may be used to support future post-market clinical studies in this population
Where is the study run from?
1. Leeds Teaching Hospitals NHS Trust (Leeds)
2. Atherstone Surgery (Atherstone)
3. Westcliffe Medical Centre (Shipley)
4. Ashfields Primary Care Centre (Sandbach)
5. Kiltearn Medical Centre (Nantwich)
6. Eynsham Medical Group (Eynsham)
7. Trowbridge Health Centre (Trowbridge)
8. Beacon Medical Group (Plymouth)
9. Salford Royal NHS Foundation Trust (Salford)
When is the study starting and how long is it expected to run for?
Proposed start date 21/10/2019 to proposed end date 03/12/2019
Who is funding the study?
The study is funded by Abbott Diabetes Care Ltd
Who is the main contact?
Dr Pamela Reid
Contact information
Public
Abbott Diabetes Care
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| Pamela.Reid@abbott.com |
Study information
| Study design | Prospective open-label multi-centre single-arm pilot study in both hospital and GP practice settings |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pilot Study to Assess use of FreeStyle Libre Pro with HbA1c in Determining Diabetes Management |
| Study objectives | This pilot study is being conducted to determine whether understanding of diabetes status and management is better with use of HbA1c with FreeStyle Libre Pro than with HbA1c alone |
| Ethics approval(s) | Approved 07/10/2019, NRES Committee: East Midlands – Nottingham 2 Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8035; NRESCommittee.eastmidlands-nottingham2@nhs.net), ref: 19/EM/0304, IRAS Project ID: 271103 |
| Health condition(s) or problem(s) studied | Diabetes Mellitus (Diabetes) |
| Intervention | Participants will wear two FreeStyle Libre Pro Flash Glucose Monitoring Sensors for up to 14 days. There is no follow-up period unless the participant experiences an unanticipated adverse device effect (UADE). Healthcare professionals will complete questionnaires using the HbA1c results alone and also using HbA1c results and the reports generated from the FreeStyle Libre Pro system. Two sensors are to be applied to allow data collection to continue in case one sensor becomes detached during the study. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre Pro Flash Glucose Monitoring Sensor |
| Primary outcome measure | Responses to HCP questionnaire using HbA1c results alone Responses to a second questionnaire using HbA1c results and the reports generated from the FreeStyle Libre Pro system |
| Secondary outcome measures | Glycaemic measures, measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration. 1. Time in hypoglycaemia (<3.9 mmol/L) 2. Time in hyperglycaemia (>10.0 mmol/L) 3. Time in range (3.9-10.0 mmol/L) 4. Mean glucose, SD glucose and CV glucose |
| Overall study start date | 01/08/2019 |
| Completion date | 23/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Age at least 18 years 2. Type 2 diabetes, on oral glucose-lowering medication, or, oral glucose-lowering medication and biphasic insulin |
| Key exclusion criteria | 1. Currently prescribed basal insulin 2. Currently prescribed bolus insulin 3. Currently prescribed glucagon-like peptide 1 (GLP-1) without being prescribed biphasic insulin 4. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition 5. Has a pacemaker or any other neurostimulators 6. Currently receiving dialysis treatment or planning to receive dialysis during the study 7. Women who are pregnant, plan to become pregnant or become pregnant during the study 8. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management 9. Known (or suspected) allergy to medical grade adhesives 10. In the investigator’s opinion the participant is unsuitable to participate due to any other cause/reason |
| Date of first enrolment | 21/10/2019 |
| Date of final enrolment | 09/12/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| Pamela.Reid@abbott.com | |
"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 | 23/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal. Estimated timeline is one year from trial end date. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Pamela Reid. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Basic results | 21/11/2024 | No | No |
Additional files
Editorial Notes
21/11/2024: The basic results have been uploaded as an additional file.
27/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 03/12/2019 to 09/12/2019.
2. The overall trial end date has been changed from 31/12/2019 to 23/12/2019.
3. The intention to publish date has been changed from 31/12/2020 to 23/12/2020.
4. The final enrolment number has been added.
14/10/2019: Trial’s existence confirmed by HRA and HCRW.
