Performance of mylife YpsoPump in routine care of adults and adolescents with type 1 diabetes: Effectiveness and Safety of a touch screen based insulin infusion pump in a non-interventional Study (The YES-Study)

Performance of mylife YpsoPump in routine care of adults and adolescents with type 1 diabetes: Effectiveness and Safety of a touch screen based insulin infusion pump in a non-interventional Study (The YES-Study) - YES-Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011246

Enrollment

100

Registered

2016-10-25

Start date

2016-09-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10

Interventions

Group 1: Therapy with mylife YpsoPump (Insulin pump for continuous insulin infusion) for 12 months

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 - Patient is expected for visits each 3 months within the next 12 months at the study center - Signed informed consent

Exclusion criteria

Exclusion criteria: - Not cured 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
HbA1c (laboratory value) before beginning of the therapy and after 3, 6, 9 and 12 months	—

Secondary

Measure	Time frame
Secondary outcome parameters are variables of contentness, appraisal and the observed advantages of the mylife YpsoPump within one year after beginning of the therapy: - DTSQs (survey) - Observed advantages of the therapy with the insulin pump (new validated survey) - Assessment of the insulin pump by the patient (survey) - Clinical complications and events (hypo- or hyperglycaemia, ketoacidosis, etc.) (survey, patient´s diary and download of the insulin pump data - Clinically relevant failings of the insulin pump system (clinical data, patient´s diary) - Number of early changes of infusion sets (patient´s diary)	—

Measure

Time frame

Secondary outcome parameters are variables of contentness, appraisal and the observed advantages of the mylife YpsoPump within one year after beginning of the therapy: - DTSQs (survey) - Observed advantages of the therapy with the insulin pump (new validated survey) - Assessment of the insulin pump by the patient (survey) - Clinical complications and events (hypo- or hyperglycaemia, ketoacidosis, etc.) (survey, patient´s diary and download of the insulin pump data - Clinically relevant failings of the insulin pump system (clinical data, patient´s diary) - Number of early changes of infusion sets (patient´s diary)

—

Countries

Germany, Switzerland

Contacts

Public ContactAndreas Buhr

Ypsomed AG

andreas.buhr@ypsomed.com+41 (0)34 42 44 111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026