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Extended Wear of a Steel and a Teflon Insulin Infusion Set

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

YpsoPump Orbit soft

YpsoPump Orbit micro

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Soft cannula first

Steel cannula first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency of early infusion set changes

Time to early infusion set changes

Frequency of early infusion set changes due to infusion site infection

Median infusion set wearing time

Daily mean glucose

Based on Continuous Glucose Monitoring

Daily mean glucose

Based on self measured blood glucose

Total daily insulin dose

Glucose variability

Coefficient of variation

Full Information

NCT ID

NCT03683368

First Posted

September 20, 2018

Last Updated

March 28, 2019

Sponsor

Ypsomed AG

1. Study Identification

Unique Protocol Identification Number

NCT03683368

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 9, 2018 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ypsomed AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soft cannula first

Arm Type

Experimental

Arm Description

Arm Title

Steel cannula first

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

YpsoPump Orbit soft

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

YpsoPump Orbit micro

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to infusion set failure due to an occlusion

Description

Time Frame

up to 7 days

Secondary Outcome Measure Information:

Title

Frequency of early infusion set changes

Time Frame

up to 7 days

Title

Time to early infusion set changes

Time Frame

up to 7 days

Title

Frequency of early infusion set changes due to infusion site infection

Time Frame

up to 7 days

Title

Median infusion set wearing time

Time Frame

up to 7 days

Title

Daily mean glucose

Description

Based on Continuous Glucose Monitoring

Time Frame

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

Title

Daily mean glucose

Description

Based on self measured blood glucose

Time Frame

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

Title

Total daily insulin dose

Time Frame

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

Title

Glucose variability

Description

Coefficient of variation

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guido Freckmann, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andreas Buhr, Dr.

Organizational Affiliation

Ypsomed AG, Burgdorf, Switzerland

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Ulm

ZIP/Postal Code

89081

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

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Extended Wear of a Steel and a Teflon Insulin Infusion Set

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