Actively Recruiting
EkiYou-Study-2 Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation
Led by DiappyMed · Updated on 2025-06-18
154
Participants Needed
16
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
DiappyMed
Lead Sponsor
S
Sanoia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the EkiYou V2 Digital Therapy in adults with diabetes who use multiple daily insulin injections as part of a basal-bolus insulin regimen. This multicenter randomized controlled trial aims to compare the performance of this digital therapy with conventional insulin management methods and assess user satisfaction and quality of life. The study is sponsored by DiappyMed and follows 154 adults over a 6-month period. Participants will be randomly assigned to either receive the EkiYou V2 device at the start or continue their standard basal-bolus insulin care for three months before switching to the device for the remaining three months. The EkiYou V2 is a mobile application that supports insulin dose estimation, including basal insulin dose, insulin-to-carb ratios, and correction factors. It uses a large food database, accounts for meals, physical activity, and glucose levels, and connects to continuous glucose monitoring (CGM) devices. During the 6-month study, participants will attend three visits and complete electronic questionnaires to report their quality of life and satisfaction with the application. Researchers will monitor glucose control through CGM data, measuring time spent in the target glucose range and other glucose-related outcomes. Safety events and adverse effects related to the device will also be tracked throughout the trial.
CONDITIONS
Brief 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 years or older
- Have type 1, type 2, or pancreatic 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 used 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 management platform
- For type 2 diabetes patients using 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 recent 14-day period
- Own a smartphone with Android 5.0+ or iOS 12.0+ connected to the internet and able to receive CGM data
- Able to read or use a smartphone without visual impairment needing special typography
- For those of childbearing potential, must have a pregnancy test or use effective contraception
- Be affiliated to a French social security scheme
You will not qualify if you...
- Pregnant or breastfeeding women
- Type 1 diabetes patients treated with hypoglycemia-inducing agents other than insulin
- Insulin-resistant patients prescribed more than 1 unit/kg/day or more than 200 units/day
- Patients with very low insulin needs, less than 15 units/day
- Patients with gastroparesis
- History of diabetic ketoacidosis or severe hypoglycemia requiring third-party help within 6 months prior to inclusion
- Pancreatic disease secondary to chronic alcohol use
- Medical conditions interfering with the protocol as judged by the investigator
- Patients who cannot be monitored for 3 months
- Intellectual disabilities preventing use of the application or questionnaire completion
- Participation in another clinical trial or unauthorized drug use 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants are randomized to use the EkiYou V2 application for insulin bolus calculation either immediately at inclusion or after a three-month control period using their standard basal bolus management method.
3 visits including the inclusion visit
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
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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