Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-08 @ 4:52 PM
Study NCT ID:
NCT06529705
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A00433-44 | OTHER | ANSM | View |