Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529705
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections EkiYou-Study1
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
EkiYou-Study-1 is an interventional beforeafter clinical investigation according to EU 2017745 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 basalbolus 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None