Extended Wear of a Steel and a Teflon Insulin Infusion Set

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: YpsoPump Orbit soft; Device: YpsoPump Orbit micro

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89081
    • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soft cannula first; 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; Insulin infusion sets will be used for up to 7 days or until failure; Device: YpsoPump Orbit micro; Insulin infusion sets will be used for up to 7 days or until failure
Experimental: Steel cannula first; 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; Insulin infusion sets will be used for up to 7 days or until failure; Device: YpsoPump Orbit micro; Insulin infusion sets will be used for up to 7 days or until failure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ypsomed AG
• Investigators: Principal Investigator: Guido Freckmann, MD, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; Study Director: Andreas Buhr, Dr., Ypsomed AG, Burgdorf, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: YPU105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No