Clinical trial NCT06529705: Performance and Safety Evaluation of the EkiYou V2 Application in Patients with Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
Official title: Performance and Safety Evaluation of the EkiYou V2 Application in Patients with Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 1
Diabetes Type 2 on Insulin
Pancreatogenous Diabetes
Keywords: Decision support system
Digital health
Continuous glucose monitoring
Precision insulin management
Insulin titration
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: DiappyMed
First posted: 2024-07-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adults with type 1, type 2 diabetes or pancreatogenic diabetes treated by multiple daily insulin injections
Primary purpose: OTHER

Brief summary: EkiYou-Study-1 is an interventional before/after clinical investigation according to EU 2017/745. It is conducted in 21 adults with diabetes and treated by multiple daily insulin injections.

After a run-in period of 2 weeks, participants will receive for 6 weeks EkiYou V2 application 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 aim of the study is to assess the safety and performance of EkiYou V2 device. Data on glycemic control, safety, quality of life and satisfaction of participants will be collected.

Detailed description: Participants of the study must be adults treated by multiple daily insulin injection in a basal/bolus insulin schema and users of a continuous glucose monitor (CGM). The study involves 5 visits, each two weeks. Participants will be included for 8 weeks divided in two distinct periods :

* Run-in period for two weeks to collect glycemic control at baseline with their standard insulin management
* Intervention period for 6 weeks where participant will receive the investigational device EkiYou V2 to manage their insulin injection.

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.

Eligibility criteria: Inclusion Criteria :

* Be over 18 years old;
* Have type 1, type 2, or pancreatogenic diabetes;
* Have been treated with multiple daily injections of insulin in a basal/bolus regimen for at least 6 months;
* Be using a continuous glucose monitoring device such as Dexcom G6 or Dexcom One for at least 2 weeks;
* Have a time in the glycemic target range (70-180 mg/dl) of less than 70%;
* Require at least 15 units of insulin therapy per day;
* Use a rapid-acting insulin compatible with the device, such as Novorapid, Humalog, Apidra, Asparte, Sanofi, Fiasp, or Lyumjev;
* Use a long-acting insulin compatible with the device, such as Lantus, Abasaglar, Toujeo, Levemir, or Tresiba;
* Be able to read and use a smartphone;
* Have no visual impairment requiring a specific font for smartphones;
* Have basic knowledge of smartphone use;
* Indicate their willingness to follow the protocol and sign a written informed consent

Exclusion Criteria:

* Ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within 6 months prior to inclusion;
* Treatment with any hypoglycemia-inducing agent other than insulin (including sulfonylureas and SGLT-2 inhibitors);
* Daily insulin requirement exceeding 200 U/day;
* Suffering from gastroparesis;
* Pancreatopathy secondary to chronic alcoholism;
* Known medical condition that, in the investigator's opinion, may interfere with the protocol;
* Participation in another clinical trial or administration of an unapproved medication within 4 weeks prior to screening;
* Not affiliated with a social security system;
* Vulnerable subject: minors, or adults under protection as defined by the Public Health Code, pregnant or breastfeeding women, subjects under guardianship or deprived of liberty;
* Person under legal protection;
* Person participating in another study with an ongoing exclusion period

Primary outcomes:
measure: Change in the percentage of time in range 70-180 mg/dL
timeFrame: Through study completion, an average of 8 weeks
Secondary outcomes:
measure: Number of non-serious adverse events related or unrelated to the device
timeFrame: Through study completion, an average of 8 weeks
measure: Number of non-serious adverse events related or unrelated to the device
timeFrame: Through study completion, an average of 8 weeks
measure: Number of serious clinical adverse events (SAEs)
timeFrame: Through study completion, an average of 8 weeks
measure: Number of serious clinical adverse events (SAEs)
timeFrame: Through study completion, an average of 8 weeks
measure: Number of other serious adverse events related or unrelated to the device
timeFrame: Through study completion, an average of 8 weeks
measure: Number of non-serious and unexpected adverse events related to the device
timeFrame: Through study completion, an average of 8 weeks
measure: Change in the percentage of time below 54 mg/dL
timeFrame: 2 weeks follow-up
measure: Change in the percentage of time below 54 mg/dL
timeFrame: 8 weeks follow-up
measure: Change in the percentage of time below 70 mg/dL
timeFrame: 2 weeks follow-up
measure: Change in the percentage of time below 70 mg/dL
timeFrame: 8 weeks follow-up
measure: Change in the percentage of time above 180 mg/dL
timeFrame: 2 weeks follow-up
measure: Change in the percentage of time above 180 mg/dL
timeFrame: 8 weeks follow-up
measure: Change in the percentage of time above 250 mg/dL
timeFrame: 2 weeks follow-up
measure: Change in the percentage of time above 250 mg/dL
timeFrame: 8 weeks follow-up
measure: Change in the Glucose Management Indicator (GMI)
timeFrame: 2 weeks follow-up
measure: Change in the Glucose Management Indicator (GMI)
timeFrame: 8 weeks follow-up
measure: Percentage of patients with time in range 70-180 mg/dL above or equal to 70%
timeFrame: 2 weeks follow-up
measure: Percentage of patients with time in range 70-180 mg/dL above or equal to 70%
timeFrame: 8 weeks follow-up
measure: Change in Mean blood glucose level
timeFrame: 2 weeks follow-up
measure: Change in Mean blood glucose level
timeFrame: 8 weeks follow-up
measure: Change in Coefficient of variation of blood glucose
timeFrame: 2 weeks follow-up
measure: Change in Coefficient of variation of blood glucose
timeFrame: 8 weeks follow-up
measure: Number of level 2 hypoglycemic episodes
timeFrame: 2 weeks follow-up
measure: Number of level 2 hypoglycemic episodes
timeFrame: 8 weeks follow-up
measure: Total Daily Insulin (Units/kg)
timeFrame: 2 weeks follow-up
measure: Change in Total Daily Insulin (Units/kg)
timeFrame: 8 weeks follow-up
measure: Total Insulin Delivered Via Basal (Units/kg)
timeFrame: 2 weeks follow-up
measure: Change in total Insulin Delivered Via Basal (Units/kg)
timeFrame: 8 weeks follow-up
measure: Number per day and total Insulin Delivered Via Bolus (Units/kg)
timeFrame: 2 weeks follow-up
measure: Change in number per day and total Insulin Delivered Via Bolus (Units/kg)
timeFrame: 8 weeks follow-up
measure: Number of connectivity issues with the application reported by the user
timeFrame: 8 weeks follow-up
measure: Questionnaire System Usability scale
timeFrame: 8 weeks follow-up
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: At inclusion visit
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 8 weeks follow-up
measure: Hypoglycemia Fear Survey 2 (HFS II)
timeFrame: At inclusion visit
measure: Hypoglycemia Fear Survey 2 (HFS II)
timeFrame: 8 weeks follow-up
measure: Number of daily insulin injections calculated from application data
timeFrame: 8 weeks follow-up
measure: Average number of daily interactions calculated from application data
timeFrame: 8 weeks follow-up
measure: Number of active application users
timeFrame: 8 weeks follow-up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
Study officials:
affiliation: CHU de Montpellier
name: Orianne VILLARD, MD
role: PRINCIPAL_INVESTIGATOR
References: