Diabetes Mellitus, Type 1NCT05096325
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
An observational study of Diabetes Mellitus, Type 1, run by mylife Diabetes Care AG at 2 sites in 2 countries.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- YpsoPump® insulin pump system
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jan 2022to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target study population consists of adult active users of CSII.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm
Switzerland1 site
Universitätsklinik für Diabetologie, Endokrinologie Ernährungsmedizin & Metabolismus
Bern
About this study
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
- Being tested
- YpsoPump® insulin pump system
- Keywords
- Continuous subcutaneous insulin infusion, mylife™ YpsoPump®, Occlusion detection algorithm
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YpsoPump® insulin pump systemDevice
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 group | Role | What they receive |
|---|---|---|
| Study pump | Subjects receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. Receives: Device: YpsoPump® insulin pump system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (3)
Retrospective description of the number of occlusions detected including the FIR Filter evaluation
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.
Measured: 28 days
Qualitative evaluation of the false positive alarms
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®.
Measured: 28 days
Qualitative assessement of the state of the adhesive tapes after study completion
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start3 Jan 2022
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- mylife Diabetes Care AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DCB Research AG
- Responsible party
- Sponsor
- Investigators
- Ingo Braun, Study director, mylife Diabetes Care AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096325
- Sponsor's protocol ID
- YPU107
- Status last verified
- Jan 2022
- First submitted
- 14 Oct 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05096325
- Acronym / sponsor ID
- YPU107
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Continuous subcutaneous insulin infusion, mylife™ YpsoPump®, Occlusion detection algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- mylife Diabetes Care AGIndustry (pharma, biotech, devices)
- Collaborators
- DCB Research AG
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study pump | – | Device: YpsoPump® insulin pump systemSubjects receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target study population consists of adult active users of CSII.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YpsoPump® insulin pump systemThe 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. | Device | Study pump |
Primary outcome
Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system.
Time frame: 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.
3 secondary outcomes
Retrospective description of the number of occlusions detected including the FIR Filter evaluation
Time frame: 28 days
Qualitative evaluation of the false positive alarms
Time frame: 28 days
Qualitative assessement of the state of the adhesive tapes after study completion
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingo Braun study director
mylife Diabetes Care AG
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by mylife Diabetes Care AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.