Performance and Safety Evaluation of the EkiYou V2 Application in Patients With Diabetes Using Multiple Daily Insulin Injections (EkiYou-Study1)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Type 1; Pancreatogenous Diabetes; Diabetes Type 2 on Insulin
• Intervention / Treatment: Device: EkiYou V2

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Montpellier, France, France, 34000
      • Centre Hospitalier Universitaire de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, Dexcom One or Freestyle Libre 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults with diabetes treated by MDI	Device: EkiYou V2; Use of a mobile application that help 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 8 weeks
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.	Through study completion, an average of 8 weeks
Number of serious clinical adverse events (SAEs)	Number of severe level 3 hypoglycemic events requiring hospitalization	Through study completion, an average of 8 weeks
Number of serious clinical adverse events (SAEs)	Number of episodes of diabetic ketoacidosis requiring hospitalization	Through study completion, an average of 8 weeks
Number of other serious adverse events related or unrelated to the device		Through study completion, an average of 8 weeks
Number of non-serious and unexpected adverse events related to the device		Through study completion, an average of 8 weeks
Change in the percentage of time below 54 mg/dL	Percentage of time with glucose below 54 mg/dL as measured by CGM	2 weeks follow-up
Change in the percentage of time below 54 mg/dL	Percentage of time with glucose below 54 mg/dL as measured by CGM	8 weeks follow-up
Change in the percentage of time below 70 mg/dL	Percentage of time with glucose below 70 mg/dL as measured by CGM	2 weeks follow-up
Change in the percentage of time below 70 mg/dL	Percentage of time with glucose below 70 mg/dL as measured by CGM	8 weeks follow-up
Change in the percentage of time above 180 mg/dL	Percentage of time with glucose above 180 mg/dL as measured by CGM	2 weeks follow-up
Change in the percentage of time above 180 mg/dL	Percentage of time with glucose above 180 mg/dL as measured by CGM	8 weeks follow-up
Change in the percentage of time above 250 mg/dL	Percentage of time with glucose above 250 mg/dL as measured by CGM	2 weeks follow-up
Change in the percentage of time above 250 mg/dL	Percentage of time with glucose above 250 mg/dL as measured by CGM	8 weeks follow-up
Change in the Glucose Management Indicator (GMI)	GMI as measured by CGM	2 weeks follow-up
Change in the Glucose Management Indicator (GMI)	GMI as measured by CGM	8 weeks follow-up
Percentage of patients with time in range 70-180 mg/dL above or equal to 70%	Time in range 70-180 mg/dL as measured by CGM	2 weeks follow-up
Percentage of patients with time in range 70-180 mg/dL above or equal to 70%	Time in range 70-180 mg/dL as measured by CGM	8 weeks follow-up
Change in Mean blood glucose level	Mean sensor glucose as measured by CGM	2 weeks follow-up
Change in Mean blood glucose level	Mean sensor glucose as measured by CGM	8 weeks follow-up
Change in Coefficient of variation of blood glucose	Coefficient of variation of blood glucose as measured by CGM	2 weeks follow-up
Change in Coefficient of variation of blood glucose	Coefficient of variation of blood glucose as measured by CGM	8 weeks follow-up
Number of level 2 hypoglycemic episodes	Defined as blood glucose below 54 mg/dL for more than 15 minutes	2 weeks follow-up
Number of level 2 hypoglycemic episodes	Defined as blood glucose below 54 mg/dL for more than 15 minutes	8 weeks follow-up
Total Daily Insulin (Units/kg)		2 weeks follow-up
Change in Total Daily Insulin (Units/kg)		8 weeks follow-up
Total Insulin Delivered Via Basal (Units/kg)		2 weeks follow-up
Change in total Insulin Delivered Via Basal (Units/kg)		8 weeks follow-up
Number per day and total Insulin Delivered Via Bolus (Units/kg)		2 weeks follow-up
Change in number per day and total Insulin Delivered Via Bolus (Units/kg)		8 weeks follow-up
Number of connectivity issues with the application reported by the user		8 weeks follow-up
Number of daily insulin injections calculated from application data		8 weeks follow-up
Average number of daily interactions calculated from application data		8 weeks follow-up
Number of active application users	Defined as at least 14 recorded injections in the application over a 2-week period	8 weeks follow-up
Questionnaire System Usability scale	Device usability questionnaire. The lower the score, more the participant agrees with the item; a higher score indicates disagreement with the item.	8 weeks follow-up
Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Quality of life associated with diabetes questionnaire. Treatment Satisfaction: Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range: 0 to 36). The higher the score, the greater the satisfaction with treatment. Individual satisfaction with treatment items (items 1, 4, 5, 6, 7 & 8) can be considered separately: All rated: 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). The higher the score, the greater the satisfaction with each aspect of treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems	At inclusion visit
Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Quality of life associated with diabetes questionnaire Treatment Satisfaction: Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range: 0 to 36). The higher the score, the greater the satisfaction with treatment. Individual satisfaction with treatment items (items 1, 4, 5, 6, 7 & 8) can be considered separately: All rated: 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). The higher the score, the greater the satisfaction with each aspect of treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems	8 weeks follow-up
Hypoglycemia Fear Survey 2 (HFS II)	Fear of hypoglycemia questionnaire. Behavioral Subscale, Items: 1-15 Score Range: 0 to 75. Higher scores indicate more frequent behaviors aimed at avoiding hypoglycemia, reflecting a greater fear of low blood sugar episodes. Worry Subscale, Items: 16-33 Score Range: 0 to 90. Higher scores suggest greater concern or anxiety about the consequences of hypoglycemia, including physical symptoms and impact on daily activities. Total Score Range: 0 to 165 (sum of both subscales). A higher total score indicates a more intense overall fear of hypoglycemia, affecting both behavior and emotional well-being.	At inclusion visit
Hypoglycemia Fear Survey 2 (HFS II)	Fear of hypoglycemia questionnaire. Behavioral Subscale, Items: 1-15 Score Range: 0 to 75. Higher scores indicate more frequent behaviors aimed at avoiding hypoglycemia, reflecting a greater fear of low blood sugar episodes. Worry Subscale, Items: 16-33 Score Range: 0 to 90. Higher scores suggest greater concern or anxiety about the consequences of hypoglycemia, including physical symptoms and impact on daily activities. Total Score Range: 0 to 165 (sum of both subscales). A higher total score indicates a more intense overall fear of hypoglycemia, affecting both behavior and emotional well-being.	8 weeks follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: DiappyMed
• Investigators: Principal Investigator: Orianne VILLARD, MD, CHU de Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Digital health; Decision support system; Precision insulin management; Insulin titration
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RECHMPL23_0453; 2024-A00433-44 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No