Diabetes Type 1NCT06738849
EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
A study testing EkiYou V2 in people with Diabetes Type 1 and Diabetes Type 2 on Insulin, run by DiappyMed at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1, Diabetes Type 2 on Insulin, Pancreatogenous Diabetes
- What is being tested?
- EkiYou V2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 16 sitesFrance
- Study dates
- 5 Nov 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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 join
- 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,
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- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites, 16 recruiting
- Recruiting
APHP Avicennes
Bobigny
Emmanuel Cosson, emmanuel.cosson@aphp.fr
- Recruiting
CHU CAEN
Caen
Michael Joubert, joubert-m@chu-caen.fr
- Recruiting
IDNC
Chartres
Said Bekka, zgouga@aol.com
- Recruiting
CHSF Corbeil-Essonnes
Corbeil-Essonnes
Alfred Penfornis, alfred.penfornis@chsf.fr
- Recruiting
Cabinet Dr Picard
Dijon
Sylvie Picard, DocSylviePicard@diabetes21.fr
- Recruiting
GH Le Havre - Hôpital Jacques Monod
Le Havre
Clémence Bures, clemence.bures@ch-havre.fr
- Recruiting
CHU Limoges - Dupuytren
Limoges
Laurence Salle, laurence.salle@unilim.fr
- Recruiting
Fondation Ambroise Paré / HEM
Marseille
Pauline SCHAEPELYNCK, p.schaepelynck@hopital-europeen.fr
- Recruiting
Cabinet Dr Navaranne
Mérignac
Anne Navaranne
- Recruiting
University Hospital, Montpellier
Montpellier
Eric Renard, e-renard@chu-montpellier.fr
- Recruiting
APHP - Hôpital La Pitié Salpêtrière
Paris
Chloé Amouyal, chloe.amouyal@aphp.fr
- Recruiting
CH Périgueux
Périgueux
Christine Coffin, christine.coffin@ch-perigueux.fr
- Recruiting
Cabinet Dr Diedisheim
Saint-Cyr-sur-Loire
Marc Diedisheim, dr.marc.diedisheim@gmail.com
- Recruiting
Cabinet Dr Gervaise
Saint-Cyr-sur-Loire
Nathalie Gervaise, nathalie.gervaise@wanadoo.fr
- Recruiting
CHU Toulouse - Hôpital Rangueil
Toulouse
Hélène Hanaire, hanaire.h@chu-toulouse.fr
- Recruiting
Clinique Pasteur
Toulouse
Christine Rouby, crouby@clinique-pasteur.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- EkiYou V2
- Keywords
- decision support system, digital therapy, bolus advisor, flexible insulin therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EkiYou V2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The interventional device EkiYou V2 will be used at inclusion following randomization. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At three Month Versus Inclusion
Secondary outcomes (14)
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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Number of serious clinical adverse events (SAEs)
Number of severe level 3 hypoglycemic events requiring hospitalization
Measured: Through study completion, an average of 6 months
Number of serious clinical adverse events (SAEs)
Number of episodes of diabetic ketoacidosis requiring hospitalization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At month 3 and Month 6
Change in the Glucose Management Indicator (GMI)
GMI as measured by CGM
Measured: At month 3 and Month 6
Change in Mean blood glucose level
Mean sensor glucose as measured by CGM
Measured: At month 3 and Month 6
Change in Coefficient of variation of blood glucose
Coefficient of variation of blood glucose as measured by CGM
Measured: At month 3 and Month 6
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Quality of life associated with diabetes questionnaire
Measured: At month 3 and Month 6
EQ-5D-5L questionnaire
Quality of life associated with diabetes questionnaire
Measured: At month 3 and Month 6
ADDQoL-19 questionnaire
Quality of life associated with diabetes questionnaire
Measured: At month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start5 Nov 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the control group will switch to the interventional device after the first three months of the study
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DiappyMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanoia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738849
- Sponsor's protocol ID
- 2024-A01531-46
- Status last verified
- Jun 2025
- First submitted
- 4 Dec 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation
- ClinicalTrials.gov ID
- NCT06738849
- Acronym / sponsor ID
- 2024-A01531-46
- Keywords
- decision support system, digital therapy, bolus advisor, flexible insulin therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- DiappyMedIndustry (pharma, biotech, devices)
- Collaborators
- Sanoia
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the control group will switch to the interventional device after the first three months of the study
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: EkiYou V2The interventional device EkiYou V2 will be used at inclusion following randomization. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EkiYou V2Use 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. | Device | Intervention Arm |
Primary outcome
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
14 secondary outcomes
Number of non-serious adverse events related or unrelated to the device
Time frame: 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
Number of serious clinical adverse events (SAEs)
Time frame: 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
Change in the percentage of time below 54 mg/dL
Time frame: At Month 3 and Month 6
Change in the percentage of time below 70 mg/dL
Time frame: At Month 3 and Month 6
Change in the percentage of time above 180 mg/dL
Time frame: At Month 3 and Month 6
Change in the percentage of time above 250 mg/dL
Time frame: At month 3 and Month 6
Change in the Glucose Management Indicator (GMI)
Time frame: At month 3 and Month 6
Change in Mean blood glucose level
Time frame: At month 3 and Month 6
Change in Coefficient of variation of blood glucose
Time frame: At month 3 and Month 6
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: At month 3 and Month 6
EQ-5D-5L questionnaire
Time frame: At month 3 and Month 6
ADDQoL-19 questionnaire
Time frame: At month 3 and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EkiYou V2 in people with Diabetes Type 1 and Diabetes Type 2 on Insulin, run by DiappyMed at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Diouri, PhD (+33 6 27 17 79 49, omar.diouri@diappymed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage of time in range 70-180 mg/dL (time frame: At three Month Versus Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.