Evaluation of the EkiYou V2 app for insulin management in diabetes patients

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

This study is testing a new app called EkiYou V2 to see if it can help adults with diabetes who use insulin manage their blood sugar better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Montpellier (Academic / other)
• Locations: 1 site (Montpellier)
• Trial ID: NCT06529705 on ClinicalTrials.gov

What this trial studies

The EkiYou-Study1 is an interventional clinical investigation assessing the performance and safety of the EkiYou V2 application in adults with diabetes who use multiple daily insulin injections. Participants will undergo a two-week run-in period to establish baseline glycemic control before using the EkiYou V2 app for six weeks, which helps estimate daily insulin doses and adjusts insulin parameters weekly. The study will collect data on glycemic control, safety, quality of life, and participant satisfaction throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with type 1, type 2, or pancreatogenic diabetes who are treated with multiple daily insulin injections and use a continuous glucose monitoring device.

Not a fit: Patients with severe hypoglycemia or ketoacidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance insulin management and improve glycemic control for patients with diabetes.

How similar studies have performed: Other studies have shown promise in using digital health applications for diabetes management, indicating potential success for this approach.

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

Where this trial is running

Montpellier

• Centre Hospitalier Universitaire de Montpellier — Montpellier, France (Recruiting)

Study contacts

• Principal investigator: Orianne VILLARD, MD — CHU de Montpellier
• Study coordinator: Orianne VILLARD, MD

Conditions Diabetes Type 1; Diabetes Type 2 on Insulin; Pancreatogenous Diabetes; Decision support system; Digital health; Continuous glucose monitoring; Precision insulin management; Insulin titration