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Diabetes Type 1NCT06529705

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

A study testing EkiYou V2 in people with Diabetes Type 1 and Diabetes Type 2 on Insulin, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
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
21 participants
Where
1 siteFrance
Study dates
19 Aug 2024to 27 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

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 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;
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, France, 34000

Other trials in France

About this study

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.

Read the 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.
Being tested
EkiYou V2
Keywords
Decision support system, Digital health, Continuous glucose monitoring, Precision insulin management, Insulin titration
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 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.

Study groups in NCT06529705
Study groupRoleWhat they receive
Adults with diabetes treated by MDIExperimentalNot described
Receives: Device: EkiYou V2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Through study completion, an average of 8 weeks

Secondary outcomes (39)
  1. 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 8 weeks

  2. 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 8 weeks

  3. Number of serious clinical adverse events (SAEs)

    Number of severe level 3 hypoglycemic events requiring hospitalization

    Measured: Through study completion, an average of 8 weeks

  4. Number of serious clinical adverse events (SAEs)

    Number of episodes of diabetic ketoacidosis requiring hospitalization

    Measured: Through study completion, an average of 8 weeks

  5. Number of other serious adverse events related or unrelated to the device

    Measured: Through study completion, an average of 8 weeks

  6. Number of non-serious and unexpected adverse events related to the device

    Measured: Through study completion, an average of 8 weeks

  7. Change in the percentage of time below 54 mg/dL

    Percentage of time with glucose below 54 mg/dL as measured by CGM

    Measured: 2 weeks follow-up

  8. Change in the percentage of time below 54 mg/dL

    Percentage of time with glucose below 54 mg/dL as measured by CGM

    Measured: 8 weeks follow-up

  9. Change in the percentage of time below 70 mg/dL

    Percentage of time with glucose below 70 mg/dL as measured by CGM

    Measured: 2 weeks follow-up

  10. Change in the percentage of time below 70 mg/dL

    Percentage of time with glucose below 70 mg/dL as measured by CGM

    Measured: 8 weeks follow-up

  11. Change in the percentage of time above 180 mg/dL

    Percentage of time with glucose above 180 mg/dL as measured by CGM

    Measured: 2 weeks follow-up

  12. Change in the percentage of time above 180 mg/dL

    Percentage of time with glucose above 180 mg/dL as measured by CGM

    Measured: 8 weeks follow-up

  13. Change in the percentage of time above 250 mg/dL

    Percentage of time with glucose above 250 mg/dL as measured by CGM

    Measured: 2 weeks follow-up

  14. Change in the percentage of time above 250 mg/dL

    Percentage of time with glucose above 250 mg/dL as measured by CGM

    Measured: 8 weeks follow-up

  15. Change in the Glucose Management Indicator (GMI)

    GMI as measured by CGM

    Measured: 2 weeks follow-up

  16. Change in the Glucose Management Indicator (GMI)

    GMI as measured by CGM

    Measured: 8 weeks follow-up

  17. 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

    Measured: 2 weeks follow-up

  18. 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

    Measured: 8 weeks follow-up

  19. Change in Mean blood glucose level

    Mean sensor glucose as measured by CGM

    Measured: 2 weeks follow-up

  20. Change in Mean blood glucose level

    Mean sensor glucose as measured by CGM

    Measured: 8 weeks follow-up

  21. Change in Coefficient of variation of blood glucose

    Coefficient of variation of blood glucose as measured by CGM

    Measured: 2 weeks follow-up

  22. Change in Coefficient of variation of blood glucose

    Coefficient of variation of blood glucose as measured by CGM

    Measured: 8 weeks follow-up

  23. Number of level 2 hypoglycemic episodes

    Defined as blood glucose below 54 mg/dL for more than 15 minutes

    Measured: 2 weeks follow-up

  24. Number of level 2 hypoglycemic episodes

    Defined as blood glucose below 54 mg/dL for more than 15 minutes

    Measured: 8 weeks follow-up

  25. Total Daily Insulin (Units/kg)

    Measured: 2 weeks follow-up

  26. Change in Total Daily Insulin (Units/kg)

    Measured: 8 weeks follow-up

  27. Total Insulin Delivered Via Basal (Units/kg)

    Measured: 2 weeks follow-up

  28. Change in total Insulin Delivered Via Basal (Units/kg)

    Measured: 8 weeks follow-up

  29. Number per day and total Insulin Delivered Via Bolus (Units/kg)

    Measured: 2 weeks follow-up

  30. Change in number per day and total Insulin Delivered Via Bolus (Units/kg)

    Measured: 8 weeks follow-up

  31. Number of connectivity issues with the application reported by the user

    Measured: 8 weeks follow-up

  32. 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.

    Measured: 8 weeks follow-up

  33. 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

    Measured: At inclusion visit

  34. 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

    Measured: 8 weeks follow-up

  35. 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.

    Measured: At inclusion visit

  36. 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.

    Measured: 8 weeks follow-up

  37. Number of daily insulin injections calculated from application data

    Measured: 8 weeks follow-up

  38. Average number of daily interactions calculated from application data

    Measured: 8 weeks follow-up

  39. Number of active application users

    Defined as at least 14 recorded injections in the application over a 2-week period

    Measured: 8 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start19 Aug 2024
  3. Primary completion27 Mar 2025
  4. Study completion27 Mar 2025

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Adults with type 1, type 2 diabetes or pancreatogenic diabetes treated by multiple daily insulin injections
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529705
Sponsor's protocol ID
RECHMPL23_0453
Other IDs
2024-A00433-44
Status last verified
Sep 2025
First submitted
15 Jul 2024
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 University Hospital, Montpellier at 1 site 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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: Through study completion, an average of 8 weeks). 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 15 Sep 2025.

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