Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
NCT Number: NCT06529705
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Type 1|Diabetes Type 2 on Insulin|Pancreatogenous Diabetes
Interventions: DEVICE: EkiYou V2
Sponsor: University Hospital, Montpellier
Collaborators: DiappyMed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2025-03
Locations: Centre Hospitalier Universitaire de Montpellier, Montpellier, 34000, France

Summary:
EkiYou-Study-1 is an interventional before/after clinical investigation according to EU 2017/745. It is conducted in 21 adults with diabetes and treated by multiple daily insulin injections.

After a run-in period of 2 weeks, participants will receive for 6 weeks EkiYou V2 application 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 aim of the study is to assess the safety and performance of EkiYou V2 device. Data on glycemic control, safety, quality of life and satisfaction of participants will be collected.

Primary Outcome Measures: Change in the percentage of time in range 70-180 mg/dL, Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM, Through study completion, an average of 8 weeks
Secondary Outcome Measures: Number of non-serious adverse events related or unrelated to the device, Severe hypoglycemia (Level 3) with blood glucose below 54 mg/dL and requiring assistance from an external person for carbohydrates intake or glucagon use., Through study completion, an average of 8 weeks|Number of non-serious adverse events related or unrelated to the device, Severe hyperglycemia (Level 3) defined by the presence of ketonemia \> 3 mmol/L or ketonemia \> 1 mmol/L and requiring consultation with a healthcare professional., Through study completion, an average of 8 weeks|Number of serious clinical adverse events (SAEs), Number of severe level 3 hypoglycemic events requiring hospitalization, Through study completion, an average of 8 weeks|Number of serious clinical adverse events (SAEs), Number of episodes of diabetic ketoacidosis requiring hospitalization, Through study completion, an average of 8 weeks|Number of other serious adverse events related or unrelated to the device, Through study completion, an average of 8 weeks|Number of non-serious and unexpected adverse events related to the device, Through study completion, an average of 8 weeks|Change in the percentage of time below 54 mg/dL, Percentage of time with glucose below 54 mg/dL as measured by CGM, 2 weeks follow-up|Change in the percentage of time below 54 mg/dL, Percentage of time with glucose below 54 mg/dL as measured by CGM, 8 weeks follow-up|Change in the percentage of time below 70 mg/dL, Percentage of time with glucose below 70 mg/dL as measured by CGM, 2 weeks follow-up|Change in the percentage of time below 70 mg/dL, Percentage of time with glucose below 70 mg/dL as measured by CGM, 8 weeks follow-up|Change in the percentage of time above 180 mg/dL, Percentage of time with glucose above 180 mg/dL as measured by CGM, 2 weeks follow-up|Change in the percentage of time above 180 mg/dL, Percentage of time with glucose above 180 mg/dL as measured by CGM, 8 weeks follow-up|Change in the percentage of time above 250 mg/dL, Percentage of time with glucose above 250 mg/dL as measured by CGM, 2 weeks follow-up|Change in the percentage of time above 250 mg/dL, Percentage of time with glucose above 250 mg/dL as measured by CGM, 8 weeks follow-up|Change in the Glucose Management Indicator (GMI), GMI as measured by CGM, 2 weeks follow-up|Change in the Glucose Management Indicator (GMI), GMI as measured by CGM, 8 weeks follow-up|Percentage of patients with time in range 70-180 mg/dL above or equal to 70%, Time in range 70-180 mg/dL as measured by CGM, 2 weeks follow-up|Percentage of patients with time in range 70-180 mg/dL above or equal to 70%, Time in range 70-180 mg/dL as measured by CGM, 8 weeks follow-up|Change in Mean blood glucose level, Mean sensor glucose as measured by CGM, 2 weeks follow-up|Change in Mean blood glucose level, Mean sensor glucose as measured by CGM, 8 weeks follow-up|Change in Coefficient of variation of blood glucose, Coefficient of variation of blood glucose as measured by CGM, 2 weeks follow-up|Change in Coefficient of variation of blood glucose, Coefficient of variation of blood glucose as measured by CGM, 8 weeks follow-up|Number of level 2 hypoglycemic episodes, Defined as blood glucose below 54 mg/dL for more than 15 minutes, 2 weeks follow-up|Number of level 2 hypoglycemic episodes, Defined as blood glucose below 54 mg/dL for more than 15 minutes, 8 weeks follow-up|Total Daily Insulin (Units/kg), 2 weeks follow-up|Change in Total Daily Insulin (Units/kg), 8 weeks follow-up|Total Insulin Delivered Via Basal (Units/kg), 2 weeks follow-up|Change in total Insulin Delivered Via Basal (Units/kg), 8 weeks follow-up|Number per day and total Insulin Delivered Via Bolus (Units/kg), 2 weeks follow-up|Change in number per day and total Insulin Delivered Via Bolus (Units/kg), 8 weeks follow-up|Number of connectivity issues with the application reported by the user, 8 weeks follow-up|Questionnaire System Usability scale, Device usability questionnaire, 8 weeks follow-up|Diabetes Treatment Satisfaction Questionnaire (DTSQ), Quality of life associated with diabetes questionnaire, At inclusion visit|Diabetes Treatment Satisfaction Questionnaire (DTSQ), Quality of life associated with diabetes questionnaire, 8 weeks follow-up|Hypoglycemia Fear Survey 2 (HFS II), Fear of hypoglycemia questionnaire, At inclusion visit|Hypoglycemia Fear Survey 2 (HFS II), Fear of hypoglycemia questionnaire, 8 weeks follow-up|Number of daily insulin injections calculated from application data, 8 weeks follow-up|Average number of daily interactions calculated from application data, 8 weeks follow-up|Number of active application users, Defined as at least 14 recorded injections in the application over a 2-week period, 8 weeks follow-up