Clinical trial NCT05096325: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Continuous subcutaneous insulin infusion
mylife™ YpsoPump®
Occlusion detection algorithm
Lead sponsor: Ypsomed AG
Sponsor class: INDUSTRY
Collaborators: name: DCB Research AG
First posted: 2021-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target study population consists of adult active users of CSII.

Brief summary: A common difficulty related to the insulin pumps are occlusions of the insulin infusion set (IIS). This study aims to evaluate the performance of a new software algorithm to detect catheter-occlusion in silico in order to refine the current automated occlusion detection algorithm of the mylife™ YpsoPump®.


Eligibility criteria: Inclusion Criteria:

1. Written Informed Consent
2. Subject is diagnosed with T1D
3. Subject on CSII (except patch pumps) for at least 6 months
4. Subject using any type of insulin approved for mylife™ YpsoPump®: Fiasp®, NovoRapid®, Humalog®, Apidra®, Lispro Sanofi
5. Subject using a CGM system for at least 6 months
6. Age ≥ 18
7. Subject willing to continue CSII with mylife™ YpsoPump® during the study
8. Subject willing to use CGM system during the study
9. 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
10. HbA1c \< 9.5% (based on last measurement by treating physician)

Exclusion Criteria:

1. Known allergy/hypersensitivity to medical grade adhesives and/or to physical activity tracker material
2. Known severe nickel allergies
3. History of frequent catheter abscesses associated with pump therapy
4. Treatment with \> 1000 mg of acetaminophen every 6 hours
5. Treatment with hydroxyurea
6. 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
7. Severe late complications of diabetes mellitus, e.g. severe macro- and/or micro-angiopathy (as determined by the investigator)
8. Known hypoglycaemia unawareness
9. Occurrence of self-reported severe hypoglycaemia event requiring third-party assistance within the last 6 months prior to study start
10. Occurrence of self-reported diabetic ketoacidosis requiring healthcare assistance within the last 6 months prior to study start
11. Participation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation
12. 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)
13. Dependency from the sponsor or the clinical investigator
14. Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject

Primary outcomes:
measure: Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system.
timeFrame: 28 days
Secondary outcomes:
measure: Retrospective description of the number of occlusions detected including the FIR Filter evaluation
timeFrame: 28 days
measure: Qualitative evaluation of the false positive alarms
timeFrame: 28 days
measure: Qualitative assessement of the state of the adhesive tapes after study completion
timeFrame: 28 days
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
city: Bern
country: Switzerland
facility: Universitätsklinik für Diabetologie, Endokrinologie Ernährungsmedizin & Metabolismus
Study officials:
affiliation: Ypsomed AG
name: Ingo Braun
role: STUDY_DIRECTOR
References: