Retrospective chart review of FreeStyle Libre in adults with type 2 diabetes
| ISRCTN | ISRCTN15121154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15121154 |
| IRAS number | 312330 |
| Secondary identifying numbers | ADC-UK-PMS-22054, IRAS 312330, CPMS 52369 |
- Submission date
- 09/09/2022
- Registration date
- 03/10/2022
- Last edited
- 18/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background & 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 review the effectiveness of the FreeStyle Libre Glucose Monitoring System in adults with type 2 diabetes using insulin.
Who can participate?
Anyone aged 18 years old and over with type 2 diabetes
What does the study involve?
For each medical record, HbA1c levels will be collected after 3 to 6 months of use of the FreeStyle Libre sensor and will be compared with their HbA1c levels before starting FreeStyle Libre.
What are the possible benefits & risks of participating?
There are no direct benefits or risks to patients whose medical records are included.
Where is the study run from?
Abbott Diabetes Care (UK)
When is the study starting and how long is it expected to run for?
February 2022 to January 2024
Who is funding the study?
Abbott Diabetes Care (UK)
Who is the main contact?
Dr Pamela Reid (UK)
pamela.reid@abbott.com
Contact information
Public
Range Road
Witney
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| pamela.reid@abbott.com |
Study information
| Study design | Retrospective non-interventional chart review study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | A retrospective, non-interventional, chart review study of the effectiveness of FreeStyle Libre in adults with type 2 diabetes |
| Study acronym | REFER-UK |
| Study hypothesis | Effectiveness of FreeStyle Libre flash glucose monitoring system on glycaemic control versus standard of care measured by HbA1c, using patient records |
| Ethics approval(s) | Approved 02/08/2022, this is a retrospective observational study reviewing medical charts, which does not require ethics approval under the UK's law, ref: 22/NRS/0022 |
| Condition | Diabetes mellitus (diabetes) |
| Intervention | Patient HbA1c levels that were collected 3 to 6 months after the start of FreeStyle Libre are compared to HbA1c levels collected prior to starting Libre. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre sensor |
| Primary outcome measure | Hemoglobin A1c (HbA1c) level measured using the FreeStyle Libre sensor and recorded in medical charts at baseline and 3 to 6 months after initiation |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/02/2022 |
| Overall study end date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | At least 78 medical records that satisfy the inclusion/exclusion criteria |
| Participant inclusion criteria | 1. Age 18 years or over 2. Has type 2 diabetes using basal-bolus insulin regimen for at least 1 year 3. Has used FreeStyle Libre/Libre 2 regularly for at least 3 months 4. HbA1c recorded in medical notes between 8.0% and 12.0% (64 to 108 mmol/mol) in the 3 months prior to starting FreeStyle Libre/Libre 2 5. HbA1c recorded in medical notes 3 to 6 months after starting FreeStyle Libre/Libre 2 |
| Participant exclusion criteria | 1. Female participant who was pregnant during the data collection period 2. Received dialysis treatment during the data collection period 3. Participated in another device or drug study that could have affected glucose measurements or management during the data collection period |
| Recruitment start date | 04/10/2022 |
| Recruitment end date | 11/09/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
EH54 6PP
United Kingdom
EH16 4SA
United Kingdom
EH4 2XU
United Kingdom
ML2 0DP
United Kingdom
SA12 7BX
United Kingdom
SA6 6NL
United Kingdom
SA2 8QA
United Kingdom
BT41 2RL
United Kingdom
NN1 5BD
United Kingdom
SO40 2RZ
United Kingdom
CV2 2DV
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
England
United Kingdom
| Phone | +44 (0)1993863024 |
|---|---|
| adc.clinical.affairs.uk@abbott.com | |
| Website | https://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 | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. Presentation at a diabetes conference Estimated timeline is one year from trial end date |
| IPD sharing plan | All study data sourced for this study comes directly from data recorded in medical charts, so can be obtained from original source via appropriate approval, rather than from the sponsor. |
Editorial Notes
18/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 11/09/2023.
2. The overall end date was changed from 31/12/2023 to 31/01/2024.
30/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2023 to 31/12/2023.
2. The overall end date was changed from 30/06/2023 to 31/12/2023.
3. The plain English summary was updated to reflect these changes.
29/03/2023: The following changes were made to the trial record:
1. The overall trial end date has been changed from 31/03/2023 to 30/06/2023 and the plain English summary updated accordingly.
2. The recruitment end date was changed from 31/12/2022 to 30/06/2023.
3. The intention to publish date was changed from 31/03/2024 to 30/06/2024.
01/11/2022: Internal review.
26/09/2022: Trial’s existence confirmed by Health and Care Research Wales (HCRW).
