An interventional study of EkiYou V2 in Diabetes Type 1, Diabetes Type 2 on Insulin and Pancreatogenous Diabetes, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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.
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 :
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:
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Time frame: Through study completion, an average of 8 weeks
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.
Time frame: 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.
Time frame: Through study completion, an average of 8 weeks
Number of serious clinical adverse events (SAEs)
Number of severe level 3 hypoglycemic events requiring hospitalization
Time frame: Through study completion, an average of 8 weeks
Number of serious clinical adverse events (SAEs)
Number of episodes of diabetic ketoacidosis requiring hospitalization
Time frame: Through study completion, an average of 8 weeks
Number of other serious adverse events related or unrelated to the device
Time frame: Through study completion, an average of 8 weeks
Number of non-serious and unexpected adverse events related to the device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks follow-up
Change in the Glucose Management Indicator (GMI)
GMI as measured by CGM
Time frame: 2 weeks follow-up
Change in the Glucose Management Indicator (GMI)
GMI as measured by CGM
Time frame: 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
Time frame: 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
Time frame: 8 weeks follow-up
Change in Mean blood glucose level
Mean sensor glucose as measured by CGM
Time frame: 2 weeks follow-up
Change in Mean blood glucose level
Mean sensor glucose as measured by CGM
Time frame: 8 weeks follow-up
Change in Coefficient of variation of blood glucose
Coefficient of variation of blood glucose as measured by CGM
Time frame: 2 weeks follow-up
Change in Coefficient of variation of blood glucose
Coefficient of variation of blood glucose as measured by CGM
Time frame: 8 weeks follow-up
Number of level 2 hypoglycemic episodes
Defined as blood glucose below 54 mg/dL for more than 15 minutes
Time frame: 2 weeks follow-up
Number of level 2 hypoglycemic episodes
Defined as blood glucose below 54 mg/dL for more than 15 minutes
Time frame: 8 weeks follow-up
Total Daily Insulin (Units/kg)
Time frame: 2 weeks follow-up
Change in Total Daily Insulin (Units/kg)
Time frame: 8 weeks follow-up
Total Insulin Delivered Via Basal (Units/kg)
Time frame: 2 weeks follow-up
Change in total Insulin Delivered Via Basal (Units/kg)
Time frame: 8 weeks follow-up
Number per day and total Insulin Delivered Via Bolus (Units/kg)
Time frame: 2 weeks follow-up
Change in number per day and total Insulin Delivered Via Bolus (Units/kg)
Time frame: 8 weeks follow-up
Number of connectivity issues with the application reported by the user
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks follow-up
Number of daily insulin injections calculated from application data
Time frame: 8 weeks follow-up
Average number of daily interactions calculated from application data
Time frame: 8 weeks follow-up
Number of active application users
Defined as at least 14 recorded injections in the application over a 2-week period
Time frame: 8 weeks follow-up
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier