Clinical trial NCT03683368: Extended Wear of a Steel and a Teflon Insulin Infusion Set
Official title: Extended Wear of a Steel and a Teflon Insulin Infusion Set
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Ypsomed AG
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to infusion set failure due to an occlusion
timeFrame: up to 7 days
Secondary outcomes:
measure: Frequency of early infusion set changes
timeFrame: up to 7 days
measure: Time to early infusion set changes
timeFrame: up to 7 days
measure: Frequency of early infusion set changes due to infusion site infection
timeFrame: up to 7 days
measure: Median infusion set wearing time
timeFrame: up to 7 days
measure: Daily mean glucose
timeFrame: day 1, 2, 3, 4, 5, 6, 7
measure: Daily mean glucose
timeFrame: day 1, 2, 3, 4, 5, 6, 7
measure: Total daily insulin dose
timeFrame: day 1, 2, 3, 4, 5, 6, 7
measure: Glucose variability
timeFrame: day 1, 2, 3, 4, 5, 6, 7
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study officials:
affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
name: Guido Freckmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ypsomed AG, Burgdorf, Switzerland
name: Andreas Buhr, Dr.
role: STUDY_DIRECTOR
References: