Extended Wear of a Steel and a Teflon Insulin Infusion Set
Not Applicable
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: YpsoPump Orbit softDevice: YpsoPump Orbit micro
- Registration Number
- NCT03683368
- Lead Sponsor
- Ypsomed AG
- Brief Summary
This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Soft cannula first YpsoPump Orbit micro 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. Steel cannula first YpsoPump Orbit soft 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. Steel cannula first YpsoPump Orbit micro 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. Soft cannula first YpsoPump Orbit soft 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.
- Primary Outcome Measures
Name Time Method Time to infusion set failure due to an occlusion up to 7 days an occlusion is defined by blood ketone concentration is \> or = 0.6 mmol/l with blood glucose (BG) concentration \>250 mg/dl, or BG concentration is \>250 mg/dl for more than 2 h and a subsequent correction bolus failed, or pump occlusion alarm that cannot be fixed.
- Secondary Outcome Measures
Name Time Method Median infusion set wearing time up to 7 days Time to early infusion set changes up to 7 days Frequency of early infusion set changes due to infusion site infection up to 7 days Daily mean glucose day 1, 2, 3, 4, 5, 6, 7 Based on self measured blood glucose
Frequency of early infusion set changes up to 7 days Total daily insulin dose day 1, 2, 3, 4, 5, 6, 7 Glucose variability day 1, 2, 3, 4, 5, 6, 7 Coefficient of variation
Trial Locations
- Locations (1)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
🇩🇪Ulm, Germany