CSII Continuous Subcutaneous Insulin Infusion, insulin pump therapie E10
Conditions
Interventions
Group 1: Pump-experienced adult people with type-1-diabetes use the mylife YpsoPump system for 30 days according the intended use.
Sponsors
Ypsomed AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed and dated informed consent - Adult (=18 years old when signing informed consent) - At least 1 year of personal experience with insulin pump therapy using insulin analogue - Willing to continue insulin pump therapy with the YpsoPump system during study - Willing to perform self-monitoring of BG at least four times per day
Exclusion criteria
Exclusion criteria: - Severe late complications of diabetes mellitus, e.g. severe macro- and/or micro-angiopathy (as determined by the investigator) - Pregnancy or lactation period or active child wish (women only) - Unstable chronic disease other than diabetes (e.g. coronary artery disease, hypertension, renal disease) or any known life-threatening disease - Occurrence of self-reported severe hypoglycemic event requiring third party or health care assistance within the last 12 months prior to study start - Occurrence of self-reported diabetic ketoacidosis (severe, with hospitalization) within the last 6 months prior to study start - Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation - Current addiction to alcohol or substances of abuse as determined by the investigator - Known hypoglycemia unawareness - Any other condition that the investigator feels would interfere with trial participation or evaluation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| User evaluation of the mylife™ YpsoPump® system by post-questionnaire after 30 days homeuse. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline characteristics, ease-of-use, handling and usability. User evaluation by post-questionnair after 30 days of homeuse, safety data by event protocolls of the investigators. | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT)
Outcome results
None listed