Tests the EkiYou app for calculating insulin doses in adults with diabetes
Tests an app that helps adults with diabetes on multiple daily insulin estimate their doses.
Key facts
- Who runs it
- DiappyMed
- Where
- Bobigny, Caen, Chartres, Corbeil-Essonnes, Dijon, Le Havre, Limoges, Marseille, Mérignac, Montpellier, Paris, Périgueux, Saint-Cyr-sur-Loire, and Toulouse, FranceSee the 16 sites
- Trial code
- Registry title
- EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
- Status
- Recruiting
- People taking part
- 154 people, planned
- Started
- 5 Nov 2024
- Expected to end
- 30 Nov 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- EkiYou V2
- Record updated
- 18 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes, type 2 diabetes or diabetes caused by pancreas disease. They must take several insulin injections a day and use a glucose sensor.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Type 1 diabetes, type 2 diabetes or diabetes secondary to pancreatic disease, treated with multi-injection basal/bolus insulin for at least 6 months
- Earlier treatment
- Must have used a compatible rapid insulin and a compatible long-acting insulin. Must have used a continuous glucose monitoring device for at least 3 months. People with type 2 diabetes on another hypoglycemia-inducing agent need no dose change for at least 3 months.
- Biomarker or test result
- At least 70% of CGM data recorded over a 14-day window close to the inclusion date
Main reasons for not taking part
- Pregnant or breast-feeding women
- Insulin dose above 1 U/kg/day or above 200 U/day, or below 15 U/day
- Gastroparesis
- Diabetic ketoacidosis or severe level 3 hypoglycemia needing help from another person in the 6 months before inclusion
- Pancreatic disease caused by chronic ethanolism
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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
Who cannot take part
- type 1 diabetic patients treated with any hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors),
- diabetic ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within the 6 months prior to inclusion,
- participation in another clinical trial or administration of a non-authorised drug in the 4 weeks preceding the screening,
- pancreatic disease secondary to chronic ethanolism,
- known medical condition that, in the investigator's opinion, may interfere with the protocol,
- pregnant or breast-feeding women,
- 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,
- patient who cannot be monitored for 3 months,
- intellectual ability compromising use of the application, comprehension or completion of questionnaires,
- person taking part in another research study with an exclusion period still in progress,
- under guardianship or curatorship,
- imprisoned or otherwise deprived of liberty
Where in France
- APHP AvicennesBobigny, FranceContact: Emmanuel CossonTaking people
- CHU CaenCaen, FranceContact: Michael JoubertTaking people
- IDNCChartres, FranceContact: Said BekkaTaking people
- CHSF Corbeil-EssonnesCorbeil-Essonnes, FranceContact: Alfred PenfornisTaking people
- Cabinet Dr PicardDijon, FranceContact: Sylvie PicardTaking people
- GH Le Havre - Hôpital Jacques MonodLe Havre, FranceContact: Clémence BuresTaking people
- CHU Limoges - DupuytrenLimoges, FranceContact: Laurence SalleTaking people
- Fondation Ambroise Paré / HEMMarseille, FranceContact: Pauline SCHAEPELYNCKTaking people
- Cabinet Dr NavaranneMérignac, FranceContact: Anne NavaranneTaking people
- University Hospital, MontpellierMontpellier, FranceContact: Eric RenardTaking people
- APHP-Hopital la Pitie SalpetriereParis, FranceContact: Chloé AmouyalTaking people
- CH PérigueuxPérigueux, FranceContact: Christine CoffinTaking people
- Cabinet Dr DiedisheimSaint-Cyr-sur-Loire, FranceContact: Marc DiedisheimTaking people
- Cabinet Dr GervaiseSaint-Cyr-sur-Loire, FranceContact: Nathalie GervaiseTaking people
- Chu Toulouse Hopital RangueilToulouse, FranceContact: Hélène HanaireTaking people
- Clinique PasteurToulouse, FranceContact: Christine RoubyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention ArmTreatment being tested
The interventional device EkiYou V2 will be used at inclusion following randomization.
Treatment: EkiYou V2
- Control ArmNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation
- Plain-language title
- Tests the EkiYou app for calculating insulin doses in adults with diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 June 2025