The Impact of a Structured Education and Treatment Programme (FLASH) for People with Diabetes Using a Flash Sensor-based Glucose Monitoring System: Results of a Randomized Controlled Trial

Aims: Flash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment.

Methods: We report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16-75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures.

Results: At six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (-0.28%, 95% CI -0.16% to -0.40% vs.-0.11%, 95% CI 0.00% to -0.22%; with a between-group difference of -0.17%, 95% CI -0.01% to -0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing.

Conclusion: FLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM. The study was registered in ClinicalTrials: NCT03175315.