Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial

Abstract Background People with diabetes on intensive insulin therapy need sufficient glycaemic control to prevent the onset or progression of diabetic complications. The burden of multiple daily blood glucose self-testing can be lessened by novel diabetes technology like flash glucose monitoring systems which provide more information compared to self-monitoring of blood glucose. Despite this delivered additional information studies are showing no significant effect on HbA1c reduction, but a reduced time spent in a hypoglycaemic glucose range. We assume that users of these devices need additional education and training to integrate the delivered information into treatment decisions. Therefore, FLASH, an education and treatment programme, was developed. The programme evaluation follows herein. Methods/design Patients are recruited through 40 diabetes outpatient study centres located across Germany. They will be randomly assigned to participate in the education and treatment programme (intervention group) or to obtain treatment as usual (control group). All patients have to give blood samples and to answer a bench of questionnaires during baseline assessment, at the end of the intervention, and 6 months after the end of the intervention. Physicians will be asked to declare some additional clinical data (such as details of the diabetes therapy) for every patient at every one of the three assessment points. Discussion This study is conducted as a randomised controlled trial to test the hypothesis that the newly developed education and treatment programme combined with the use of a flash glucose monitoring device (intervention group) is superior to reduce HbA1c compared to the use of flash glucose monitoring alone (control group). The first results will be expected in 2018. Trial registration ClinicalTrials.gov, ID: NCT03175315. Registered on 2 May 2017