Impact and experience of flash glucose monitoring (flash GM)
Research type
Research Study
Full title
Exploring the impact and experience of diabetes management technologies (using flash glucose monitoring (flashGM) as an exemplar) of adults living with type 1 diabetes mellitus (T1D), in the North East of England.
IRAS ID
265296
Contact name
Charlotte Gordon
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
09552, NUTH R&D reference
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
The aim of this study is to investigate the impact of wearable blood glucose management technologies on people living with type 1 diabetes who are eligible to receive such devices, through standard NHS prescription. For the purpose of this research, that will mean people using flash glucose monitoring (flashGM) devices.
Eligible participants will be adults living with type 1 diabetes who do not currently use any form of wearable glucose monitoring technology and who meet NHS England criteria to receive funding for this device. Participants will be recruited via local diabetes centre in the North of England.
The objective of the first phase of the study is to gather information in relation to changes in physiological parameters related to overall glucose control. Data related to changes in body weight and composition will also be gathered. Questionnaires to explore changes in health status, psychological well-being, treatment satisfaction and quality of life will also be administered. Further, self reported scanning frequency and low blood glucose data will also be collected. Data collection will take place before the device is started and then 6 months post initiation. Individual participation in the first phase is 6 months.
Results from phase 1 will be analysed to identify trends but also interesting or outlier results which warrant further exploration. These findings will then influence the second phase of the study where more in-depth questions and discussion will take place during focus group sessions, to explore experiences of flashGM use. Some participants from the first phase will return for focus group interviews based on their characteristics and the themes that become apparent during data analysis. Phase 2 will be a single study visit and is planned to take place after the end of participation in the first phase.Summary of Results
• Overall, there was no improvement in measures of glucose management such as time in range and in some cases this got worse. This is interesting because previous studies have shown data related to glucose management improves. This result could be because there was a lot of missing sensor data and also the number of participant was small compared to other studies. Because of this, we can’t be certain that this finding is accurate. When we talked to some participants, many they felt the sensor helped them improve their glucose management by giving them lots of information to act on.• Levels of diabetes distress and diabetes related quality of life tended to improve, because of the number of participants, we cant be sure this would be the case for everyone using the sensor, but for those in the study, overall, they had lower levels of distress and better quality of life.
• Participants were much more satisfied with Freestyle Libre 2 than finger pricking. Participants said it was convenient, mostly painless and made everyday life easier. Many participant told us that Freestyle Libre 2 was a lot less hassle than finger pricking. It drew less attention when testing in public, was less messy and allowed participants more freedom in their everyday lives. Some people felt the sensor drew attention to them, sometimes this was positive, helping them connect with other people living with diabetes; sometimes it meant that participants received unwanted questions about their diabetes.
• Interestingly, participants placed the same level of trust in the data from the Freestyle Libre 2 as they did in finger-prick testing. This could be because some people told us that the sensor could sometimes be unreliable or the data did not match how they were feeling. Some participants continued to finger prick to check their data was accurate.
• Impaired awareness of hypoglycaemia was not an issue for participants but worrying about and managing hypos day to day was still a challenge.
• Participants also told us that the sensor helped them to learn about their diabetes and sometimes led them to change their behaviour to help their glucose management. However, some told us managing lots of data and making lots of decisions could be very difficult and this sometimes made them worried they were not managing their diabetes well. Participants said they would like more help when they started using the sensor to understand their data and more support for problems with day-to-day sensor use.
• 1/3rd of participant did not use alarms. Those who did use alarms often only used a low alarm. Participants told us that the alarms could be annoying and affect not just them but their family and friends who would worry when they heard the alarms. Alarms could also draw unwanted attention from other people.
• Overall, Participants had very different experiences of using the sensor and these differences need to be considered when deciding which diabetes technologies are most suitable for the individual.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0204
Date of REC Opinion
17 Sep 2021
REC opinion
Favourable Opinion