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

NCT06529705 | Completed

• 2 other identifiers: RECHMPL23_04532024-A00433-44
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Type 1; Diabetes Type 2 on Insulin; Pancreatogenous Diabetes

Keywords

Decision support system; Digital health; Continuous glucose monitoring; Precision insulin management; Insulin titration

Outcome Measures

Primary Outcomes (1)

• Change in the percentage of time in range 70-180 mg/dL

  Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM

  Through study completion, an average of 8 weeks

Secondary Outcomes (39)

• Number of non-serious adverse events related or unrelated to the device

  Through study completion, an average of 8 weeks

• Number of non-serious adverse events related or unrelated to the device

  Through study completion, an average of 8 weeks

• Number of serious clinical adverse events (SAEs)

  Through study completion, an average of 8 weeks

• Number of serious clinical adverse events (SAEs)

  Through study completion, an average of 8 weeks

• Number of other serious adverse events related or unrelated to the device

  Through study completion, an average of 8 weeks

Study Arms (1)

Adults with diabetes treated by MDI

EXPERIMENTAL

Device: EkiYou V2

Interventions

EkiYou V2 DEVICE

Use of a mobile application that help users to evaluate their daily bolus and basal insulin needs, and that adjusts at weekly basis their insulin to carb ratios, correction factor and basal dose.

Adults with diabetes treated by MDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• DiappyMed: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, France, 34000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Orianne VILLARD, MD

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adults with type 1, type 2 diabetes or pancreatogenic diabetes treated by multiple daily insulin injections

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 31, 2024
• Study Start: August 19, 2024
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

FR (1)