Status:
COMPLETED
Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
DiappyMed
Conditions:
Diabetes Type 1
Diabetes Type 2 on Insulin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Participants of the study must be adults treated by multiple daily insulin injection in a basal/bolus insulin schema and users of a continuous glucose monitor (CGM). The study involves 5 visits, each ...
Eligibility Criteria
Inclusion
- 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, 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
- 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
Exclusion
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06529705
Start Date
August 19 2024
End Date
March 27 2025
Last Update
September 15 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, France, 34000