National Multicenter Trial of the EkiYou V2 Digital Therapy for Insulin Dose Calculation in Adults with Diabetes Using Multiple Daily Injections

What this Trial Is About

Researchers are evaluating the EkiYou V2 Digital Therapy in adults with diabetes who use multiple daily insulin injections as part of a basal-bolus insulin regimen. This multicenter randomized controlled trial aims to compare the performance of this digital therapy with conventional insulin management methods and assess user satisfaction and quality of life. The study is sponsored by DiappyMed and follows 154 adults over a 6-month period. Participants will be randomly assigned to either receive the EkiYou V2 device at the start or continue their standard basal-bolus insulin care for three months before switching to the device for the remaining three months. The EkiYou V2 is a mobile application that supports insulin dose estimation, including basal insulin dose, insulin-to-carb ratios, and correction factors. It uses a large food database, accounts for meals, physical activity, and glucose levels, and connects to continuous glucose monitoring CGM devices. During the 6-month study, participants will attend three visits and complete electronic questionnaires to report their quality of life and satisfaction with the application. Researchers will monitor glucose control through CGM data, measuring time spent in the target glucose range and other glucose-related outcomes. Safety events and adverse effects related to the device will also be tracked throughout the trial.

EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation