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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00433-44 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| DiappyMed | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with diabetes treated by MDI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EkiYou V2 | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orianne VILLARD, MD | CHU de Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Montpellier | Montpellier | France | 34000 | France |
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Adults with type 1, type 2 diabetes or pancreatogenic diabetes treated by multiple daily insulin injections
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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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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