Actively Recruiting
EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
Led by DiappyMed · Updated on 2025-06-18
154
Participants Needed
16
Research Sites
107 weeks
Total Duration
On this page
Sponsors
D
DiappyMed
Lead Sponsor
S
Sanoia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be aged 18 or over
- Have type 1, type 2, or pancreatogenous diabetes
- Have been treated with multi-injection basal/bolus insulin therapy for at least 6 months
- Use a compatible rapid insulin such as Novorapid, Humalog, Apidra, Asparte Sanofi, Fiasp, or Lyumjev
- Use a compatible long-acting insulin such as Lantus, Abasaglar, Toujeo, Levemir, or Tresiba
- Have been using a continuous glucose monitoring device like Dexcom G6, Dexcom One, Dexcom One+, or FreeStyle Libre for at least 3 months
- Have given physician access to glucose data via a data management platform
- For type 2 diabetes patients on hypoglycemia-inducing agents other than insulin, have no dosage changes for at least 3 months
- Have recorded at least 70% of CGM data over a 14-day window near inclusion
- Have a smartphone running Android 5.0 or higher or iOS 12.0 or higher connected to internet and able to receive CGM data
- Able to read or use a smartphone without visual impairment requiring special typography
- For patients of childbearing potential, have a pregnancy test before inclusion or use effective contraception
- Be affiliated with a French social security scheme
You will not qualify if you...
- Pregnant or breastfeeding women
- Type 1 diabetic patients treated with hypoglycemia-inducing agents other than insulin
- Insulin-resistant patients prescribed daily insulin doses over 1 U/kg/day or more than 200 U/day
- Patients with very low insulin requirements (less than 15 U/day)
- Patients with gastroparesis
- History of diabetic ketoacidosis or severe level 3 hypoglycemia needing third-party help within 6 months before inclusion
- Pancreatic disease due to chronic ethanolism
- Any medical condition that may interfere with the study protocol as judged by the investigator
- Patients unable to be monitored for 3 months
- Intellectual disability affecting use of the application or completion of questionnaires
- Participation in another clinical trial or use of unauthorized drugs within 4 weeks before screening
- Participation in another research study with an ongoing exclusion period
- Under guardianship or curatorship
- Imprisoned or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 16 locations
1
APHP Avicennes
Bobigny, France
Actively Recruiting
2
CHU CAEN
Caen, France
Actively Recruiting
3
IDNC
Chartres, France
Actively Recruiting
4
CHSF Corbeil-Essonnes
Corbeil-Essonnes, France
Actively Recruiting
5
Cabinet Dr Picard
Dijon, France
Actively Recruiting
6
GH Le Havre - Hôpital Jacques Monod
Le Havre, France
Actively Recruiting
7
CHU Limoges - Dupuytren
Limoges, France
Actively Recruiting
8
Fondation Ambroise Paré / HEM
Marseille, France
Actively Recruiting
9
Cabinet Dr Navaranne
Mérignac, France
Actively Recruiting
10
University Hospital, Montpellier
Montpellier, France
Actively Recruiting
11
APHP - Hôpital La Pitié Salpêtrière
Paris, France
Actively Recruiting
12
CH Périgueux
Périgueux, France
Actively Recruiting
13
Cabinet Dr Diedisheim
Saint-Cyr-sur-Loire, France
Actively Recruiting
14
Cabinet Dr Gervaise
Saint-Cyr-sur-Loire, France
Actively Recruiting
15
CHU Toulouse - Hôpital Rangueil
Toulouse, France
Actively Recruiting
16
Clinique Pasteur
Toulouse, France
Actively Recruiting
Research Team
O
Omar Diouri, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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