Model-driven diabetes care: study protocol for a randomized controlled trial

BACKGROUND: People with type 1 diabetes who use electronic self-help tools register a large amount of information about their disease on their participating devices; however, this information is rarely utilized beyond the immediate investigation. We have developed a diabetes diary for mobile phones and a statistics-based feedback module, which we have named Diastat, to give data-driven feedback to the patient based on their own data. METHOD: In this study, up to 40 participants will be given a smartphone on which is loaded a diabetes self-help application (app), the Few Touch Application (FTA). Participants will be randomized into two groups to be given access to Diastat 4 or 12 weeks, respectively after receiving the smartphone, and will use the FTA with Diastat for 8 weeks after this point. The primary endpoint is the frequency of high and low blood-glucose measurements. DISCUSSION: The study will investigate the effect of data-driven feedback to patients. Our hypothesis is that this will improve glycemic control and reduce variability. The endpoints are robust indicators that can be assembled with minimal effort by the patient beyond normal routine. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01774149