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.
Participants of the study must be adults treated with multiple daily insulin injections in a basal/bolus insulin regimen and users of a continuous glucose monitor (CGM). The study involves 3 visits (including the inclusion visit), for a total duration of 6 months for each participant. The study participants will be randomized in two groups and will receive EkiYou V2 either at inclusion or at the second visit after three-months control period. EkiYou V2 device is a new version of the previously CE-Marked device EkiYou V1. It is a decision support that include the following features to participants: * Carbohydrate counting through an extensive food database with more than 200k items. * Bolus calculation based on their meal, physical activity and blood glucose. * Bolus correction advice. * Long-acting insulin reminders and automatic periodic titration. * Insulin-to-carb ratios and correction factor automatic adjustment. * Connection to CGM devices Participants will also respond to ePRO questionnaires during the clinical investigation to collect data on their quality of life and their satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Use of a Digital Therapy in the form of a mobile application that helps users to evaluate their daily bolus and basal insulin needs, and that adjusts at weekly basis their insulin to carb ratios, correction factor and basal dose. The device includes the following features to participants: * Carbohydrate counting through an extensive food database with more than 200k items. * Bolus calculation based on their meal, physical activity and blood glucose. * Bolus correction advice. * Long-acting insulin reminders and automatic periodic titration. * Insulin-to-carb ratios and correction factor automatic adjustment.
APHP Avicennes
Bobigny, France
RECRUITINGCHU CAEN
Caen, France
RECRUITINGIDNC
Chartres, France
RECRUITINGCHSF Corbeil-Essonnes
Corbeil-Essonnes, France
RECRUITINGCabinet Dr Picard
Dijon, France
RECRUITINGGH Le Havre - Hôpital Jacques Monod
Le Havre, France
RECRUITINGCHU Limoges - Dupuytren
Limoges, France
RECRUITINGFondation Ambroise Paré / HEM
Marseille, France
RECRUITINGCabinet Dr Navaranne
Mérignac, France
RECRUITINGUniversity Hospital, Montpellier
Montpellier, France
RECRUITING...and 6 more locations
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
Time frame: At three Month Versus Inclusion
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.
Time frame: Through study completion, an average of 6 months
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.
Time frame: Through study completion, an average of 6 months
Number of serious clinical adverse events (SAEs)
Number of severe level 3 hypoglycemic events requiring hospitalization
Time frame: Through study completion, an average of 6 months
Number of serious clinical adverse events (SAEs)
Number of episodes of diabetic ketoacidosis requiring hospitalization
Time frame: Through study completion, an average of 6 months
Change in the percentage of time below 54 mg/dL
Percentage of time with glucose below 54 mg/dL as measured by CGM
Time frame: At Month 3 and Month 6
Change in the percentage of time below 70 mg/dL
Percentage of time with glucose below 70 mg/dL as measured by CGM
Time frame: At Month 3 and Month 6
Change in the percentage of time above 180 mg/dL
Percentage of time with glucose above 180 mg/dL as measured by CGM
Time frame: At Month 3 and Month 6
Change in the percentage of time above 250 mg/dL
Percentage of time with glucose above 250 mg/dL as measured by CGM
Time frame: At month 3 and Month 6
Change in the Glucose Management Indicator (GMI)
GMI as measured by CGM
Time frame: At month 3 and Month 6
Change in Mean blood glucose level
Mean sensor glucose as measured by CGM
Time frame: At month 3 and Month 6
Change in Coefficient of variation of blood glucose
Coefficient of variation of blood glucose as measured by CGM
Time frame: At month 3 and Month 6
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Quality of life associated with diabetes questionnaire
Time frame: At month 3 and Month 6
EQ-5D-5L questionnaire
Quality of life associated with diabetes questionnaire
Time frame: At month 3 and Month 6
ADDQoL-19 questionnaire
Quality of life associated with diabetes questionnaire
Time frame: At month 3 and Month 6
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