EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
Condition(s) studied
Investigational drug(s) / intervention(s)
EkiYou V2: Use of a Digital Therapy in the form of a mobile application that helps 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. The device includes 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 summary
EkiYou-Study-2 is an interventional multicenter randomised controlled clinical investigation according to EU 2017/745. It is conducted in 154 adults with diabetes and treated by multiple daily insulin injections that will be followed for 6 months.
After a randomization, participants will receive for 6 months EkiYou V2 Digital Therapy 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 control group will stay with their standard care, and after the first three months of control period, they will receive EkiYou V2 for the last three months.
The aim of this study is to examine the performance of the EkiYou V2 Digital Therapy compared with conventional methods for people with diabetes treated with multi-injections as part of a basal-bolus regimen. We also aim to assess the level of satisfaction and user experience with the EkiYou application, as well as the quality of life of study participants.
Eligibility
Primary outcome measure(s)
- Change in the percentage of time in range 70-180 mg/dL — At three Month Versus Inclusion
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| APHP Avicennes | Bobigny | France | Recruiting |
| CHU CAEN | Caen | France | Recruiting |
| IDNC | Chartres | France | Recruiting |
| CHSF Corbeil-Essonnes | Corbeil-Essonnes | France | Recruiting |
| Cabinet Dr Picard | Dijon | France | Recruiting |
| GH Le Havre - Hôpital Jacques Monod | Le Havre | France | Recruiting |
| CHU Limoges - Dupuytren | Limoges | France | Recruiting |
| Fondation Ambroise Paré / HEM | Marseille | France | Recruiting |
| Cabinet Dr Navaranne | Mérignac | France | Recruiting |
| University Hospital, Montpellier | Montpellier | France | Recruiting |
| APHP - Hôpital La Pitié Salpêtrière | Paris | France | Recruiting |
| CH Périgueux | Périgueux | France | Recruiting |
| Cabinet Dr Diedisheim | Saint-Cyr-sur-Loire | France | Recruiting |
| Cabinet Dr Gervaise | Saint-Cyr-sur-Loire | France | Recruiting |
| CHU Toulouse - Hôpital Rangueil | Toulouse | France | Recruiting |
| Clinique Pasteur | Toulouse | France | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06738849 on ClinicalTrials.gov ↗ ← All trials in France