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

NCT05096325 | Completed

• 1 other identifier: YPU107
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

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

Keywords

Continuous subcutaneous insulin infusion; mylife™ YpsoPump®; Occlusion detection algorithm

Outcome Measures

Primary Outcomes (1)

• Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system.

  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.

  28 days

Secondary Outcomes (3)

• Retrospective description of the number of occlusions detected including the FIR Filter evaluation

  28 days

• Qualitative evaluation of the false positive alarms

  28 days

• Qualitative assessement of the state of the adhesive tapes after study completion

  28 days

Study Arms (1)

Study pump

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

Device: YpsoPump® insulin pump system

Interventions

YpsoPump® insulin pump system 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.

Study pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target study population consists of adult active users of CSII.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• mylife Diabetes Care AG: lead
• DCB Research AG: collaborator

Study Sites (2)

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

Ulm, Germany

Location

Universitätsklinik für Diabetologie, Endokrinologie Ernährungsmedizin & Metabolismus

Bern, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ingo Braun

  mylife Diabetes Care AG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: January 3, 2022
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)