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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jul 26, 2024

Keywords

ClinConnect Summary

The EkiYou-Study1 is a clinical trial designed to evaluate the safety and effectiveness of a new app called EkiYou V2 for adults with diabetes who use multiple daily insulin injections. The study involves 21 participants aged 18 and older who have Type 1, Type 2, or pancreatogenic diabetes and have been on insulin for at least six months. To be eligible, participants must also use a continuous glucose monitoring device and require a specific amount of insulin each day.

During the trial, participants will first go through a two-week preparation period, followed by six weeks of using the EkiYou V2 app. This app helps them calculate their insulin doses by adjusting their daily insulin needs based on their glucose levels and food intake. Throughout the study, researchers will gather information about how well the app helps manage blood sugar levels and how satisfied participants are with their experience. It’s important to note that participants must be comfortable using a smartphone, and those with certain medical conditions or recent health issues may not qualify for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • 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 or Dexcom One 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
• Exclusion Criteria:
• • 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);
• • Daily insulin requirement exceeding 200 U/day;
• • Suffering from gastroparesis;
• • Pancreatopathy secondary to chronic alcoholism;
• • Known medical condition that, in the investigator's opinion, may interfere with the protocol;
• • Participation in another clinical trial or administration of an unapproved medication within 4 weeks prior to screening;
• • 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