EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation
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.
• 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.