Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)

Prior treatment

• Ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within 6 months prior to inclusion;
• Treatment with any hypoglycemia-inducing agent other than insulin (including sulfonylureas and SGLT-2 inhibitors);
• Participation in another clinical trial or administration of an unapproved medication within 4 weeks prior to screening;

Other illness

• Known medical condition that, in the investigator's opinion, may interfere with the protocol;

Other

• Daily insulin requirement exceeding 200 U/day;
• Suffering from gastroparesis;
• Pancreatopathy secondary to chronic alcoholism;
• Not affiliated with a social security system;
• Vulnerable subject: minors, or adults under protection as defined by the Public Health Code, pregnant or breastfeeding women, subjects under guardianship or deprived of liberty;
• Person under legal protection;
• Person participating in another study with an ongoing exclusion period

• 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