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

Launched by DIAPPYMED · Dec 13, 2024

Keywords

ClinConnect Summary

The EkiYou-Study-2 is a clinical trial looking at a new digital application called EkiYou V2, designed to help people with diabetes better manage their insulin doses. This study involves 154 adults aged 18 and older who have type 1 or type 2 diabetes and are currently using multiple daily insulin injections. Participants will be split into two groups: one group will use the EkiYou application for six months to calculate their insulin needs, while the other group will continue with their usual care for the first three months. After that, they will also start using the EkiYou app. The goal is to see how well the app works in managing insulin compared to traditional methods, as well as to understand how satisfied users are with the app and how it affects their quality of life.

To be eligible for this trial, participants must have been on insulin therapy for at least six months, use specific types of rapid and long-acting insulin, and have been using a continuous glucose monitoring device for at least three months. They also need to have access to a smartphone and be able to read or use it without any visual impairments. This study is currently recruiting, and it aims to provide valuable insights into how digital tools can improve diabetes management.

Gender

ALL

Eligibility 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.