E10
Conditions
Interventions
Group 1: Therapy with mylife YpsoPump (subcutaneous insulininjection) for 12 weeks
Sponsors
Ypsomed GmbH
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: Male or female with type 1 diabetes • Age at least 12 years • Indikation for a insulin pump • Patient has decided for the mylife YpsoPump and has a prescription for this pump • Signed informed consent
Exclusion criteria
Exclusion criteria: • Not healed malignant diseases • Chronic systemic glucocorticoid therapy • Contraindications for insulin pump use: – Lack of motivation or reliability (e.g. lack of blood glucose self-monitoring) – Missing documentation of blood glucose self-monitoring and self-therapy – Severe psychiatric problems or problems caused by an addiction (alcohol, drugs) – Patients who the investigator believes to be ineligible for participating in the study or using the YpsoPump (e. g. visual acuity, hearing capacity, therapy compliance, etc.) • Individuals who are either dependent on or employed by sponsor or investigator • Prisoners or adults under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Complications and events (survey during follow-up visits after 6 and 12 weeks) - Deficiences of the mylife YpsoPump (reportings and complaints during the 12 weeks) - Questions concerning the contentness with the therapy and about the suitibility for daily use (survey before treatment and after 6 and 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c-values (laboratory measurement before Treatment and after 12 weeks) | — |
Countries
Germany
Contacts
Public ContactKerstin Göhle
Ypsomed GmbH
Outcome results
None listed