Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
EkiYou-Study-1 is an interventional before/after clinical investigation according to EU 2017/745. It is conducted in 21 adults with diabetes and treated by multiple daily insulin injections. After a run-in period of 2 weeks, participants will receive for 6 weeks EkiYou V2 application that will help them to estimate their daily bolus and basal insulin doses. This device weekly adjusts insulin parameters including : basal insulin dose, insulin to carb ratios and correction factor. The aim of the study is to assess the safety and performance of EkiYou V2 device. Data on glycemic control, safety, quality of life and satisfaction of participants will be collected.
• Be over 18 years old;
• Have type 1, type 2, or pancreatogenic diabetes;
• Have been treated with multiple daily injections of insulin in a basal/bolus regimen for at least 6 months;
• Be using a continuous glucose monitoring device such as Dexcom G6, Dexcom One or Freestyle Libre for at least 2 weeks;
• Have a time in the glycemic target range (70-180 mg/dl) of less than 70%;
• Require at least 15 units of insulin therapy per day;
• Use a rapid-acting insulin compatible with the device, such as Novorapid, Humalog, Apidra, Asparte, Sanofi, Fiasp, or Lyumjev;
• Use a long-acting insulin compatible with the device, such as Lantus, Abasaglar, Toujeo, Levemir, or Tresiba;
• Be able to read and use a smartphone;
• Have no visual impairment requiring a specific font for smartphones;
• Have basic knowledge of smartphone use;
• Indicate their willingness to follow the protocol and sign a written informed consent