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

NCT ID: NCT05096325

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-03-01

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®.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study pump

Subjects receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data.

YpsoPump® insulin pump system

Intervention Type: DEVICE

The subjects will receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. Data will then be analysed in silico comparing the new occlusion detection algorithm with the common occlusion detection algorithm.

Interventions

YpsoPump® insulin pump system

The subjects will receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. Data will then be analysed in silico comparing the new occlusion detection algorithm with the common occlusion detection algorithm.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DCB Research AG

OTHER

Sponsor Role: collaborator

Ypsomed Diabetes Care AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingo Braun

Role: STUDY_DIRECTOR

Ypsomed Diabetes Care AG

Locations

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, , Germany

Universitätsklinik für Diabetologie, Endokrinologie Ernährungsmedizin & Metabolismus

Bern, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

YPU107

Identifier Type: -

Identifier Source: org_study_id