FSL Impact Study - version no 1
Research type
Research Study
Full title
Impact of the FreeStyle Libre on quality of life and diabetes control among those with type 1 diabetes mellitus
IRAS ID
258123
Contact name
Avibesh Gautam
Contact email
Sponsor organisation
University of Aberdeen
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The FreeStyle Libre (FSL) is a glucose monitoring device that has been introduced into NHS Grampian from September 2018 for those with type 1 diabetes mellitus. Patients with this condition must frequently monitor their blood glucose level each day. This involves pricking their skin to create a small bleed and then using a glucometer to measure the blood glucose level. In comparison, the FSL involves placing a sensor on the upper arm and swiping a reader over this sensor to obtain the glucose results. This is quicker, less invasive and more convenient for the patients than the traditional prick method.
This study will assess the impact of this device on the patient’s quality of life and diabetes control. Quality of life will be assessed through three validated questionnaires - Problem Areas in Diabetes (PAID), Hospital Anxiety and Depression Scale (HADS) and Hypoglycaemia Fear Survey (HFS). The FSL User Experience Questionnaire will be used to assess how they have been getting on with the device and how it has helped them to understand and manage their condition. Most participants will have already done at least one of the three validated questionnaires, the questionnaire results before and after the use of the FSL will be analysed. The diabetes control will be assessed through their blood test results, data from their FSL and electronic records. We will also collect data on patient characteristics and demographics to assess whether this correlates with how much impact the FSL has had on them.
The study will be conducted in the David Anderson Building, where diabetes clinics take place regularly. Patients will be approached by their doctor, who will briefly inform them about the study. Then the student will give them more information and ask them to fill out the questionnaires once written consent has been obtained.REC name
HSC REC B
REC reference
19/NI/0048
Date of REC Opinion
26 Feb 2019
REC opinion
Favourable Opinion