Ireland
--:--IST
Recruiting Not applicable

EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation

NCT06738849 · tracked via the Priya Life Science France tracker
Sponsor
DiappyMed
Phase
Not applicable
Started
2024-11-05
Last updated
2025-06-18

Condition(s) studied

Diabetes Type 1Diabetes Type 2 on InsulinPancreatogenous Diabetes

Investigational drug(s) / intervention(s)

EkiYou V2

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * be aged 18 or over, * have type 1 or type 2 diabetes or diabetes secondary to pancreatic disease, * have been treated with multi-injection basal/bolus insulin therapy for at least 6 months, * using a compatible rapid insulin with the device Ekiyou such as : Novorapid, Humalog, Apidra, Asparte Sanofi, Fiasp or Lyumjev, * using a compatible long-acting insulin with the device EkiYou such as : Lantus, Abasaglar, Toujeo, Levemir or Tresiba, * have been using a continuous glucose monitoring device such as Dexcom G6, Dexcom One, Dexcom One+ or FreeStyle Libre for at least 3 months, * have given their physician access to their glucose data via a glucose data management platform, * for type 2 diabetic patients using an hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors), have no change in dosage regimen for at least 3 months * have recorded at least 70% of CGM data over a 14-day window close to the inclusion date, * have at least one smartphone running Android 5.0 or higher or iOS 12.0 or higher connected to the internet and able to receive CGM data available to them on the day of the inclusion, * able to read or use a smartphone with no visual impairment needing specific typography, * for patients of childbearing potential, a pregnancy test must have been carried out prior to inclusion, or an effective and adequate method of contraception must be used, * be affiliated to a French social security scheme. Exclusion Criteria: * pregnant or breast-feeding women, * type 1 diabetic patients treated with any hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors), * insulin-resistant patient: prescribed daily insulin dose \> 1 U/kg/day or \> 200 U/day, * patient with very low insulin requirements: daily insulin dose \< 15 U/day, * patient with gastroparesis, * diabetic ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within the 6 months prior to inclusion, * pancreatic disease secondary to chronic ethanolism, * known medical condition that, in the investigator's opinion, may interfere with the protocol, * patient who cannot be monitored for 3 months, * intellectual ability compromising use of the application, comprehension or completion of questionnaires, * participation in another clinical trial or administration of a non-authorised drug in the 4 weeks preceding the screening, * person taking part in another research study with an exclusion period still in progress, * under guardianship or curatorship, * imprisoned or otherwise deprived of liberty.

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)

FacilityCityRegionStatus
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
Official registry record

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