Diabetes Mellitus, Type 1NCT03683368
Extended Wear of a Steel and a Teflon Insulin Infusion Set
A study testing YpsoPump Orbit soft and YpsoPump Orbit micro in people with Diabetes Mellitus, Type 1, run by mylife Diabetes Care AG at 1 site in Germany.
Trial summary
This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- YpsoPump Orbit soft and YpsoPump Orbit micro
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, 89081
About this study
This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- YpsoPump Orbit soft, YpsoPump Orbit micro
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YpsoPump Orbit softDevice
Insulin infusion sets will be used for up to 7 days or until failure
YpsoPump Orbit microDevice
Insulin infusion sets will be used for up to 7 days or until failure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: YpsoPump Orbit soft; Device: YpsoPump Orbit micro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Secondary outcomes (8)
Frequency of early infusion set changes
Measured: up to 7 days
Time to early infusion set changes
Measured: up to 7 days
Frequency of early infusion set changes due to infusion site infection
Measured: up to 7 days
Median infusion set wearing time
Measured: up to 7 days
Daily mean glucose
Based on Continuous Glucose Monitoring
Measured: day 1, 2, 3, 4, 5, 6, 7
Daily mean glucose
Based on self measured blood glucose
Measured: day 1, 2, 3, 4, 5, 6, 7
Total daily insulin dose
Measured: day 1, 2, 3, 4, 5, 6, 7
Glucose variability
Coefficient of variation
Measured: day 1, 2, 3, 4, 5, 6, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start9 Oct 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- mylife Diabetes Care AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Freckmann, MD, Principal investigator, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität UlmAndreas Buhr, Dr., Study director, Ypsomed AG, Burgdorf, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683368
- Sponsor's protocol ID
- YPU105
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Wear of a Steel and a Teflon Insulin Infusion Set
- ClinicalTrials.gov ID
- NCT03683368
- Acronym / sponsor ID
- YPU105
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- mylife Diabetes Care AGIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft cannula first | Experimental | Device: YpsoPump Orbit soft, Device: YpsoPump Orbit microSubjects 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. |
| Steel cannula first | Experimental | Device: YpsoPump Orbit soft, Device: YpsoPump Orbit microSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YpsoPump Orbit softInsulin infusion sets will be used for up to 7 days or until failure | Device | Soft cannula first, Steel cannula first |
| YpsoPump Orbit microInsulin infusion sets will be used for up to 7 days or until failure | Device | Soft cannula first, Steel cannula first |
Primary outcome
Time to infusion set failure due to an occlusion
Time frame: up to 7 days
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.
8 secondary outcomes
Frequency of early infusion set changes
Time frame: up to 7 days
Time to early infusion set changes
Time frame: up to 7 days
Frequency of early infusion set changes due to infusion site infection
Time frame: up to 7 days
Median infusion set wearing time
Time frame: up to 7 days
Daily mean glucose
Time frame: day 1, 2, 3, 4, 5, 6, 7
Daily mean glucose
Time frame: day 1, 2, 3, 4, 5, 6, 7
Total daily insulin dose
Time frame: day 1, 2, 3, 4, 5, 6, 7
Glucose variability
Time frame: day 1, 2, 3, 4, 5, 6, 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Freckmann, MD principal investigator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Andreas Buhr, Dr. study director
Ypsomed AG, Burgdorf, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YpsoPump Orbit soft and YpsoPump Orbit micro in people with Diabetes Mellitus, Type 1, run by mylife Diabetes Care AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to infusion set failure due to an occlusion (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.