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This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft cannula first | Experimental | Subjects will be randomized (50%) to the soft cannula infusion set for two weeks and then will be switched to the steel needle infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the soft cannula infusion set. |
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| Steel cannula first | Experimental | Subjects will be randomized (50%) to the steel cannula infusion set for two weeks and then will be switched to the soft cannula infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the steel cannula infusion set. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YpsoPump Orbit soft | Device | Insulin infusion sets will be used for up to 7 days or until failure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to infusion set failure due to an occlusion | an occlusion is defined by blood ketone concentration is > or = 0.6 mmol/l with blood glucose (BG) concentration >250 mg/dl, or BG concentration is >250 mg/dl for more than 2 h and a subsequent correction bolus failed, or pump occlusion alarm that cannot be fixed. | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of early infusion set changes | up to 7 days | |
| Time to early infusion set changes | up to 7 days | |
| Frequency of early infusion set changes due to infusion site infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Freckmann, MD | Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Principal Investigator |
| Andreas Buhr, Dr. | Ypsomed AG, Burgdorf, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| YpsoPump Orbit micro | Device | Insulin infusion sets will be used for up to 7 days or until failure |
|
| up to 7 days |
| Median infusion set wearing time | up to 7 days |
| Daily mean glucose | Based on Continuous Glucose Monitoring | day 1, 2, 3, 4, 5, 6, 7 |
| Daily mean glucose | Based on self measured blood glucose | day 1, 2, 3, 4, 5, 6, 7 |
| Total daily insulin dose | day 1, 2, 3, 4, 5, 6, 7 |
| Glucose variability | Coefficient of variation | day 1, 2, 3, 4, 5, 6, 7 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |