Using the EkiYou app to calculate insulin doses for diabetes management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Omar Diouri, PhD
• Email: omar.diouri@diappymed.com
• Phone: +33 6 27 17 79 49

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.