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

University Hospital Center (CHU)

Status

Enrolling

Conditions

Diabetes Type 1

Diabetes Type 2 on Insulin

Pancreatogenous Diabetes

Treatments

Device: EkiYou V2

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06529705

RECHMPL23_0453

2024-A00433-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 two weeks. Participants will be included for 8 weeks divided in two distinct periods :

Run-in period for two weeks to collect glycemic control at baseline with their standard insulin management
Intervention period for 6 weeks where participant will receive the investigational device EkiYou V2 to manage their insulin injection.

EkiYou V2 device is a new version of the previously CE-Marked device EkiYou V1. It is a decision support that include the following features to participants:

Carbohydrate counting through an extensive food database with more than 200k items.
Bolus calculation based on their meal, physical activity and blood glucose.
Bolus correction advice.
Long-acting insulin reminders and automatic periodic titration.
Insulin-to-carb ratios and correction factor automatic adjustment.

Enrollment

21 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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