Extended Wear of a Steel and a Teflon Insulin Infusion Set
NCT ID: NCT03683368
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-10-09
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Soft cannula first
Subjects will be randomized (50%) to the soft cannula infusion set for two weeks and then will be switched to the steel needle infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the soft cannula infusion set.
YpsoPump Orbit soft
Insulin infusion sets will be used for up to 7 days or until failure
YpsoPump Orbit micro
Insulin infusion sets will be used for up to 7 days or until failure
Steel cannula first
Subjects will be randomized (50%) to the steel cannula infusion set for two weeks and then will be switched to the soft cannula infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the steel cannula infusion set.
YpsoPump Orbit soft
Insulin infusion sets will be used for up to 7 days or until failure
YpsoPump Orbit micro
Insulin infusion sets will be used for up to 7 days or until failure
Interventions
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YpsoPump Orbit soft
Insulin infusion sets will be used for up to 7 days or until failure
YpsoPump Orbit micro
Insulin infusion sets will be used for up to 7 days or until failure
Eligibility Criteria
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Inclusion Criteria
* Using an insulin pump for at least 12 months
* Age ≥18 years
* Hemoglobin A1c level less than or equal to 8.5%
* Willing to use mylife™ YpsoPump® system while they are participating in the study
* Willing to use NovoRapid® insulin while they are participating in the study
* An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
* Urea, Creatinine, ALT more than three times the upper limit of normal, or thrombocytopenia (\<150 G/l)
* Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use an acceptable form of contraception during the study (for sexually active subjects of childbearing potential)
* Known severe tape reactions or allergies
* Known severe nickel allergies
* History of frequent catheter abscesses associated with pump therapy
* 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
* Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse
* Dependency from the sponsor or the clinical investigator
18 Years
ALL
No
Sponsors
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Ypsomed Diabetes Care AG
INDUSTRY
Responsible Party
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Principal Investigators
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Guido Freckmann, MD
Role: PRINCIPAL_INVESTIGATOR
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Andreas Buhr, Dr.
Role: STUDY_DIRECTOR
Ypsomed AG, Burgdorf, Switzerland
Locations
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Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, , Germany
Countries
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Other Identifiers
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YPU105
Identifier Type: -
Identifier Source: org_study_id
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