Extended Wear of a Steel and a Teflon Insulin Infusion Set

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

Official Title
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Extended Wear of a Steel and a Teflon Insulin Infusion Set

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: YpsoPump Orbit soft
* Device: YpsoPump Orbit micro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft cannula first<br>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. | Device: YpsoPump Orbit soft<br>* Insulin infusion sets will be used for up to 7 days or until failure<br>Device: YpsoPump Orbit micro<br>* Insulin infusion sets will be used for up to 7 days or until failure<br>|
| Experimental: Steel cannula first<br>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. | Device: YpsoPump Orbit soft<br>* Insulin infusion sets will be used for up to 7 days or until failure<br>Device: YpsoPump Orbit micro<br>* Insulin infusion sets will be used for up to 7 days or until failure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to infusion set failure due to an occlusion | 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. | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of early infusion set changes |  | 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 | 
| Median infusion set wearing time |  | up to 7 days | 
| Daily mean glucose | Based on Continuous Glucose Monitoring | day 1, 2, 3, 4, 5, 6, 7 | 
| Daily mean glucose | Based on self measured blood glucose | day 1, 2, 3, 4, 5, 6, 7 | 
| Total daily insulin dose |  | day 1, 2, 3, 4, 5, 6, 7 | 
| Glucose variability | Coefficient of variation | day 1, 2, 3, 4, 5, 6, 7 |