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Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK)
NA trial testing Free Style Libre 2 in Diabetes Mellitus, Type 1 in 156 participants. Completed in 10 October 2021.
| Lead sponsor | Manchester University NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 156 |
| Start date | 9 January 2020 |
| Primary completion | 10 October 2021 |
| Estimated completion | 10 October 2021 |
| Sites | 8 locations across United Kingdom |
Manchester University NHS Foundation Trust
16 and older, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary outcome is difference in HbA1c between the two groups at 24 weeks.
| Group | Value | 95% CI |
|---|---|---|
| Free Style Libre 2 Device | 62.8 | ± 8.5 |
| Self-monitoring of Blood Glucose | 67.7 | ± 9.8 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Free Style Libre 2 Device | Self-monitoring of Blood G… |
|---|---|---|---|
| Hospital admission | Endocrine disorders | — | — |
| Reaction | System | Free Style Libre 2 Device | Self-monitoring of Blood G… |
|---|---|---|---|
| skin reaction due to sensor | Product Issues | — | — |
Most-reported serious reactions: Hospital admission.
Data from ClinicalTrials.gov NCT03815006 adverse events section.
FreeStyle Libre (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days, and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes. The purpose of this study is to determine whether flash glucose monitoring with FSL2 device will improve HbA1c over 24 weeks compared to self-monitoring of blood glucose in adults and adolescents (16 or older) with sub-optimally controlled (HbA1c 7.5% to 11%) type 1 diabetes. This is an open-label, multi-centre, randomised, parallel design study, involving a 2-week run-in period, followed by a 24-week study period during which participants will use either FSL2 or continue usual finger-stick glucose monitoring in random order. A total of up to 156 randomised participants from up to 180 recruited aged 16 years and older with T1D on insulin pump therapy or multiple daily injection therapy were recruited through diabetes clinics in participating centres. Participants will receive appropriate training to maximise the benefits of FSL2 and finger-stick glucose levels in self-management. The primary outcome is the difference in HbA1c between the two groups at 24 weeks. Secondary outcomes are time spent with glucose levels above and below target, as recorded by FSL2, and other flash glucose-based metrics. Impact on quality of life, diabetes distress, mood, needle burden, disordered eating and treatment satisfaction will also be undertaken. Relative cost-effectiveness of FSL2 device compared with self-monitoring will also be assessed from a UK NHS perspective.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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