EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiappyMed
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
EkiYou V2
DeviceUse 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.
Treatment groups
154 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 InclusionSecondary outcomes
1
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 months2
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 months3
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 months4
Number of serious clinical adverse events (SAEs)
Number of episodes of diabetic ketoacidosis requiring hospitalization
Time frame
Through study completion, an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
DiappyMed
Lead sponsor
Sanoia
Collaborator
Source ClinicalTrials.gov