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

NCT06738849 | Recruiting

• 1 other identifier: 2024-A01531-46
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Diabetes Type 1; Diabetes Type 2 on Insulin; Pancreatogenous Diabetes

Keywords

decision support system; digital therapy; bolus advisor; flexible insulin therapy

Outcome Measures

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

  At three Month Versus Inclusion

Secondary Outcomes (14)

• Number of non-serious adverse events related or unrelated to the device

  Through study completion, an average of 6 months

• Number of non-serious adverse events related or unrelated to the device

  Through study completion, an average of 6 months

• Number of serious clinical adverse events (SAEs)

  Through study completion, an average of 6 months

• Number of serious clinical adverse events (SAEs)

  Through study completion, an average of 6 months

• Change in the percentage of time below 54 mg/dL

  At Month 3 and Month 6

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The interventional device EkiYou V2 will be used at inclusion following randomization.

Device: EkiYou V2

Control Arm

NO INTERVENTION

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.

Interventions

EkiYou V2 DEVICE

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• able to read or use a smartphone with no visual impairment needing specific typography,
• be affiliated to a French social security scheme.

You may not qualify if:

• 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,
• 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,
• under guardianship or curatorship,
• imprisoned or otherwise deprived of liberty.

Sponsors & Collaborators

• DiappyMed: lead
• Sanoia: collaborator

Study Sites (16)

APHP Avicennes

Bobigny, France

RECRUITING

CHU CAEN

Caen, France

RECRUITING

IDNC

Chartres, France

RECRUITING

CHSF Corbeil-Essonnes

Corbeil-Essonnes, France

RECRUITING

Cabinet Dr Picard

Dijon, France

RECRUITING

GH Le Havre - Hôpital Jacques Monod

Le Havre, France

RECRUITING

CHU Limoges - Dupuytren

Limoges, France

RECRUITING

Fondation Ambroise Paré / HEM

Marseille, France

RECRUITING

Cabinet Dr Navaranne

Mérignac, France

RECRUITING

University Hospital, Montpellier

Montpellier, France

RECRUITING

APHP - Hôpital La Pitié Salpêtrière

Paris, France

RECRUITING

CH Périgueux

Périgueux, France

RECRUITING

Cabinet Dr Diedisheim

Saint-Cyr-sur-Loire, France

RECRUITING

Cabinet Dr Gervaise

Saint-Cyr-sur-Loire, France

RECRUITING

CHU Toulouse - Hôpital Rangueil

Toulouse, France

RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Omar Diouri, PhD

CONTACT

+33 6 27 17 79 49; omar.diouri@diappymed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: the control group will switch to the interventional device after the first three months of the study

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 18, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)