Using the EkiYou app to calculate insulin doses for diabetes management
EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation
This study is testing whether the EkiYou app can help adults with diabetes better calculate their insulin doses compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | DiappyMed Industry-sponsored |
| Locations | 16 sites (Bobigny and 15 other locations) |
| Trial ID | NCT06738849 on ClinicalTrials.gov |
What this trial studies
EkiYou-Study-2 is a multicenter randomized controlled investigation involving 154 adults with diabetes who are treated with multiple daily insulin injections. Participants will be randomized to receive the EkiYou V2 Digital Therapy, which helps estimate daily bolus and basal insulin doses, or continue with standard care for the first three months before receiving the device. The study will last for six months, during which insulin parameters will be adjusted weekly based on individual needs. Additionally, participants will provide feedback on their satisfaction and user experience with the EkiYou application.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with type 1 or type 2 diabetes who are on a multi-injection basal/bolus insulin regimen and using a continuous glucose monitor.
Not a fit: Patients who are not using a continuous glucose monitor or those who do not meet the specific insulin therapy requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance insulin management for diabetes patients, leading to better glycemic control and improved quality of life.
How similar studies have performed: Other studies have shown promise in using digital therapies for insulin management, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bobigny and 15 other locations
- 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)
Study contacts
- Study coordinator: Omar Diouri, PhD
- Email: omar.diouri@diappymed.com
- Phone: +33 6 27 17 79 49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.