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| Name | Class |
|---|---|
| DCB Research AG | OTHER |
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A common difficulty related to the insulin pumps are occlusions of the insulin infusion set (IIS). This study aims to evaluate the performance of a new software algorithm to detect catheter-occlusion in silico in order to refine the current automated occlusion detection algorithm of the mylife™ YpsoPump®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study pump | Subjects receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YpsoPump® insulin pump system | Device | The subjects will receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. Data will then be analysed in silico comparing the new occlusion detection algorithm with the common occlusion detection algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system. | The primary outcome is the difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system throughout the study phase (28 days). The currently implemented method is considered as reference test. Missed alarms using the FIR filter algorithm are considered as false negative alarms while any additional alarm that is detected by the FIR filter algorithm but that was not triggered by the current reference method is considered as false positive. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective description of the number of occlusions detected including the FIR Filter evaluation | The retrospective description of the number of occlusions detected including the FIR Filter evaluation according to type of insulin, low total daily insulin (≤25U/d) and type of infusion set (micro vs soft) is based on data collected at enrolment and in patients' diaries during follow-up regarding these three characteristics. |
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Inclusion Criteria:
Exclusion Criteria:
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The target study population consists of adult active users of CSII.
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| Name | Affiliation | Role |
|---|---|---|
| Ingo Braun | mylife Diabetes Care AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | Germany | ||||
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| 28 days |
| Qualitative evaluation of the false positive alarms | The qualitative evaluation of the false positive alarms occurs with the aid of CGM data, movement data collected with a physical activity tracker and the amount of administered insulin over time. The qualitative exploration will be performed by the PIs or delegated members of the study team. They will assess visually and independently each potentially false positive alarm to determine if the alarm qualifies as correct alarm. This qualitative exploration can contribute to future refinements of the occlusion alarm system of the mylife™ YpsoPump®. | 28 days |
| Qualitative assessement of the state of the adhesive tapes after study completion | The study subjects will be asked to take pictures of each infusion set prior to change to document the status of the plaster prior to removal. The sponsor will qualitatively assess the state of the adhesive tapes after study completion. | 28 days |
| Universitätsklinik für Diabetologie, Endokrinologie Ernährungsmedizin & Metabolismus |
| Bern |
| Switzerland |
| 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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