Extended Wear of a Steel and a Teflon Insulin Infusion Set

NCT03683368 | Completed

• 1 other identifier: YPU105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  day 1, 2, 3, 4, 5, 6, 7

Study Arms (2)

Soft cannula first

EXPERIMENTAL

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; Device: YpsoPump Orbit micro

Steel cannula first

EXPERIMENTAL

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; Device: YpsoPump Orbit micro

Interventions

YpsoPump Orbit soft DEVICE

Insulin infusion sets will be used for up to 7 days or until failure

Soft cannula first; Steel cannula first

YpsoPump Orbit micro DEVICE

Insulin infusion sets will be used for up to 7 days or until failure

Soft cannula first; Steel cannula first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• mylife Diabetes Care AG: lead

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Guido Freckmann, MD

  Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

  PRINCIPAL INVESTIGATOR

• Andreas Buhr, Dr.

  Ypsomed AG, Burgdorf, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: October 9, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)