Clinical trial NCT06738849: EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
Official title: EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 1
Diabetes Type 2 on Insulin
Pancreatogenous Diabetes
Keywords: decision support system
digital therapy
bolus advisor
flexible insulin therapy
Lead sponsor: DiappyMed
Sponsor class: INDUSTRY
Collaborators: name: Sanoia
First posted: 2024-12-18
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the control group will switch to the interventional device after the first three months of the study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the percentage of time in range 70-180 mg/dL
timeFrame: At three Month Versus Inclusion
Secondary outcomes:
measure: Number of non-serious adverse events related or unrelated to the device
timeFrame: Through study completion, an average of 6 months
measure: Number of non-serious adverse events related or unrelated to the device
timeFrame: Through study completion, an average of 6 months
measure: Number of serious clinical adverse events (SAEs)
timeFrame: Through study completion, an average of 6 months
measure: Number of serious clinical adverse events (SAEs)
timeFrame: Through study completion, an average of 6 months
measure: Change in the percentage of time below 54 mg/dL
timeFrame: At Month 3 and Month 6
measure: Change in the percentage of time below 70 mg/dL
timeFrame: At Month 3 and Month 6
measure: Change in the percentage of time above 180 mg/dL
timeFrame: At Month 3 and Month 6
measure: Change in the percentage of time above 250 mg/dL
timeFrame: At month 3 and Month 6
measure: Change in the Glucose Management Indicator (GMI)
timeFrame: At month 3 and Month 6
measure: Change in Mean blood glucose level
timeFrame: At month 3 and Month 6
measure: Change in Coefficient of variation of blood glucose
timeFrame: At month 3 and Month 6
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: At month 3 and Month 6
measure: EQ-5D-5L questionnaire
timeFrame: At month 3 and Month 6
measure: ADDQoL-19 questionnaire
timeFrame: At month 3 and Month 6
Other outcomes:
Locations:
city: Bobigny
country: France
facility: APHP Avicennes
city: Caen
country: France
facility: CHU CAEN
city: Chartres
country: France
facility: IDNC
city: Corbeil-Essonnes
country: France
facility: CHSF Corbeil-Essonnes
city: Dijon
country: France
facility: Cabinet Dr Picard
city: Le Havre
country: France
facility: GH Le Havre - Hôpital Jacques Monod
city: Limoges
country: France
facility: CHU Limoges - Dupuytren
city: Marseille
country: France
facility: Fondation Ambroise Paré / HEM
city: Montpellier
country: France
facility: University Hospital, Montpellier
city: Mérignac
country: France
facility: Cabinet Dr Navaranne
city: Paris
country: France
facility: APHP - Hôpital La Pitié Salpêtrière
city: Périgueux
country: France
facility: CH Périgueux
city: Saint-Cyr-sur-Loire
country: France
facility: Cabinet Dr Diedisheim
city: Saint-Cyr-sur-Loire
country: France
facility: Cabinet Dr Gervaise
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
References: