Extended Wear of a Steel and a Teflon Insulin Infusion Set

Ypsomed

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: YpsoPump Orbit soft; Device: YpsoPump Orbit micro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03683368

YPU105

Details and patient eligibility

About

This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of type 1 diabetes for at least 12 months
• 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

• Diabetic ketoacidosis in the past 3 months prior to enrollment
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Soft cannula first

Experimental group

Description:

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.

Treatment:

Device: YpsoPump Orbit micro

Device: YpsoPump Orbit soft

Steel cannula first

Experimental group

Description:

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.

Treatment:

Device: YpsoPump Orbit micro

Device: YpsoPump Orbit soft