YpsoPump Occlusion Detection Algorithm: Collection of Real-world Data for In-silico Evaluation of a New Software Algorithm to Refine Occlusion Detection in Subjects With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

Inclusion criteria

• Written Informed Consent
• Subject is diagnosed with T1D
• Subject on CSII (except patch pumps) for at least 6 months
• Subject using any type of insulin approved for mylife™ YpsoPump®: Fiasp®, NovoRapid®, Humalog®, Apidra®, Lispro Sanofi
• Subject using a CGM system for at least 6 months
• Age ≥ 18
• Subject willing to continue CSII with mylife™ YpsoPump® during the study
• Subject willing to use CGM system during the study
• If the subject wants to use the CGM smartphone app instead of a receiver: Subject ensures to use a compatible smartphone and is willing to share CGM for the duration of the study
• HbA1c < 9.5% (based on last measurement by treating physician)

Exclusion criteria

• Known allergy/hypersensitivity to medical grade adhesives and/or to physical activity tracker material
• Known severe nickel allergies
• History of frequent catheter abscesses associated with pump therapy
• Treatment with > 1000 mg of acetaminophen every 6 hours
• Treatment with hydroxyurea
• Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
• Severe late complications of diabetes mellitus, e.g. severe macro- and/or micro-angiopathy (as determined by the investigator)
• Known hypoglycaemia unawareness
• Occurrence of self-reported severe hypoglycaemia event requiring third-party assistance within the last 6 months prior to study start
• Occurrence of self-reported diabetic ketoacidosis requiring healthcare assistance within the last 6 months prior to study start
• Participation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation
• Female subjects: pregnancy, lactation period, lack of a negative urine pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use a contraception during the study (for sexually active subjects of childbearing potential)
• Dependency from the sponsor or the clinical investigator
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject