Diabetes Mellitus, Type 1
Conditions
Brief summary
This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
Interventions
DEVICEYpsoPump Orbit soft
Insulin infusion sets will be used for up to 7 days or until failure
DEVICEYpsoPump Orbit micro
Insulin infusion sets will be used for up to 7 days or until failure
Sponsors
mylife Diabetes Care AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| Daily mean glucose | day 1, 2, 3, 4, 5, 6, 7 | Based on Continuous Glucose Monitoring |
Countries
Germany
Outcome results
None listed