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

June 17, 2025 updated by: DiappyMed

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
The interventional device EkiYou V2 will be used at inclusion following randomization.
Device: EkiYou V2

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.
No Intervention: Control Arm

Control arm with standard care for the first three months. Participants use their standard basal bolus management method by fixed doses or flexible insulin therapy.

After the initial three-months control period, participants will benefit from the investigational device EkiYou V2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the percentage of time in range 70-180 mg/dL
Time Frame: At three Month Versus Inclusion
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
At three Month Versus Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of non-serious adverse events related or unrelated to the device
Time Frame: Through study completion, an average of 6 months
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 6 months
Number of non-serious adverse events related or unrelated to the device
Time Frame: Through study completion, an average of 6 months
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 6 months
Number of serious clinical adverse events (SAEs)
Time Frame: Through study completion, an average of 6 months
Number of severe level 3 hypoglycemic events requiring hospitalization
Through study completion, an average of 6 months
Number of serious clinical adverse events (SAEs)
Time Frame: Through study completion, an average of 6 months
Number of episodes of diabetic ketoacidosis requiring hospitalization
Through study completion, an average of 6 months
Change in the percentage of time below 54 mg/dL
Time Frame: At Month 3 and Month 6
Percentage of time with glucose below 54 mg/dL as measured by CGM
At Month 3 and Month 6
Change in the percentage of time below 70 mg/dL
Time Frame: At Month 3 and Month 6
Percentage of time with glucose below 70 mg/dL as measured by CGM
At Month 3 and Month 6
Change in the percentage of time above 180 mg/dL
Time Frame: At Month 3 and Month 6
Percentage of time with glucose above 180 mg/dL as measured by CGM
At Month 3 and Month 6
Change in the percentage of time above 250 mg/dL
Time Frame: At month 3 and Month 6
Percentage of time with glucose above 250 mg/dL as measured by CGM
At month 3 and Month 6
Change in the Glucose Management Indicator (GMI)
Time Frame: At month 3 and Month 6
GMI as measured by CGM
At month 3 and Month 6
Change in Mean blood glucose level
Time Frame: At month 3 and Month 6
Mean sensor glucose as measured by CGM
At month 3 and Month 6
Change in Coefficient of variation of blood glucose
Time Frame: At month 3 and Month 6
Coefficient of variation of blood glucose as measured by CGM
At month 3 and Month 6
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time Frame: At month 3 and Month 6
Quality of life associated with diabetes questionnaire
At month 3 and Month 6
EQ-5D-5L questionnaire
Time Frame: At month 3 and Month 6
Quality of life associated with diabetes questionnaire
At month 3 and Month 6
ADDQoL-19 questionnaire
Time Frame: At month 3 and Month 6
Quality of life associated with diabetes questionnaire
At month 3 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiappyMed

Collaborators

Sanoia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01531-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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