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

Sponsor
Ypsomed AG (Industry)
Overall Status
Completed
CT.gov ID
NCT05096325
Collaborator
Diabetes Center Berne Research AG (Other)
40
2
1.9
20
10.7

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
  • Device: YpsoPump® insulin pump system

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 3, 2022
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Study pump

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

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system. [28 days]

    The primary outcome is the difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system throughout the study phase (28 days). The currently implemented method is considered as reference test. Missed alarms using the FIR filter algorithm are considered as false negative alarms while any additional alarm that is detected by the FIR filter algorithm but that was not triggered by the current reference method is considered as false positive.

Secondary Outcome Measures

  1. Retrospective description of the number of occlusions detected including the FIR Filter evaluation [28 days]

    The retrospective description of the number of occlusions detected including the FIR Filter evaluation according to type of insulin, low total daily insulin (≤25U/d) and type of infusion set (micro vs soft) is based on data collected at enrolment and in patients' diaries during follow-up regarding these three characteristics.

  2. Qualitative evaluation of the false positive alarms [28 days]

    The qualitative evaluation of the false positive alarms occurs with the aid of CGM data, movement data collected with a physical activity tracker and the amount of administered insulin over time. The qualitative exploration will be performed by the PIs or delegated members of the study team. They will assess visually and independently each potentially false positive alarm to determine if the alarm qualifies as correct alarm. This qualitative exploration can contribute to future refinements of the occlusion alarm system of the mylife™ YpsoPump®.

  3. Qualitative assessement of the state of the adhesive tapes after study completion [28 days]

    The study subjects will be asked to take pictures of each infusion set prior to change to document the status of the plaster prior to removal. The sponsor will qualitatively assess the state of the adhesive tapes after study completion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm Ulm Germany
2 Universitätsklinik für Diabetologie, Endokrinologie Ernährungsmedizin & Metabolismus Bern Switzerland

Sponsors and Collaborators

  • Ypsomed AG
  • Diabetes Center Berne Research AG

Investigators

  • Study Director: Ingo Braun, Ypsomed AG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ypsomed AG
ClinicalTrials.gov Identifier:
NCT05096325
Other Study ID Numbers:
  • YPU107
First Posted:
Oct 27, 2021
Last Update Posted:
Mar 22, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ypsomed AG
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022