Extended Wear of a Steel and a Teflon Insulin Infusion Set

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Extended Wear of a Steel and a Teflon Insulin Infusion Set

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683368
• Other study ID #: YPU105
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Ypsomed AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• YpsoPump Orbit soft
Insulin infusion sets will be used for up to 7 days or until failure
• YpsoPump Orbit micro
Insulin infusion sets will be used for up to 7 days or until failure

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Ypsomed AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of early infusion set changes		up to 7 days
Secondary	Time to early infusion set changes		up to 7 days
Secondary	Frequency of early infusion set changes due to infusion site infection		up to 7 days
Secondary	Median infusion set wearing time		up to 7 days
Secondary	Daily mean glucose	Based on Continuous Glucose Monitoring	day 1, 2, 3, 4, 5, 6, 7
Secondary	Daily mean glucose	Based on self measured blood glucose	day 1, 2, 3, 4, 5, 6, 7
Secondary	Total daily insulin dose		day 1, 2, 3, 4, 5, 6, 7
Secondary	Glucose variability	Coefficient of variation	day 1, 2, 3, 4, 5, 6, 7