Type1diabetesNCT04208282
Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.
A study testing 7 day infusion set in people with Type1diabetes, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- 7 day infusion set
- 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 siteIsrael
- Study dates
- 1 Jul 2017to 31 Mar 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a MiniMed™ VEO pump or 640G Insulin pump with or without using an Enlite™ Sensor .
- Age 18 to 80 years
- Hemoglobin A1c level less than or equal to 10%
- Not currently known to be pregnant, nor planning pregnancy during the study.
- Willingness to follow the protocol and sign the informed consent
Who cannot join
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Pregnant or lactating females
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.
Read the detailed description
This is a 1-center, prospective, open label randomized, crossover controlled study.
40 patients will be using 4 infusion sets (a total of 160 sets) that will serve as an exploratory pilot study to assess the SD of 7 day use for future study design.
Eligible patients meeting the enrollment and randomization criteria will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for4 sets (up to 28 days). The order will be determined by the randomization process:
- Arm 1: Quick-EWIS. First phase Quickset, second phase EWIS.
- Arm 2: EWIS-Quick. First phase EWIS, second phase Quickset.
Following screening and informed consenting to the trial, a randomized procedure will define the subject trial arm:
- Trial Arm A: Subjects will be randomized to a group who will be using the Quickset infusion system for the Phase 1. All patients will be retrained on the use of the Quickset infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the X infusion set, entering Phase 2. All patients will be trained at this visit on the use of the X EW infusion set by site staff and demonstrate proficiency in the use of the EW infusion set. After 28 days or after using 4 sets, the patients will return all the extracted catheters sets .
- Trial Arm B: Subjects will be randomized to a group who will be using the EWIS set infusion system for the initial Phase. All patients will be trained on the use of the EWIS infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion set, entering Phase 2. All patients will then be retrained on the use of the Quickset infusion set by site staff and demonstrate proficiency. After 28 days or after using 4 sets, the patients will all the extracted catheters sets .
An extension phase for additional one month (4 sets) will be conducted as a single arm to assess the seven day durability of sets.
- Conditions
- Type1diabetes
- Being tested
- 7 day infusion set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 day infusion setDevice
7 days survival of the sets
| Study group | Role | What they receive |
|---|---|---|
| Trial Arm A | Experimental | Quickset infusion system for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the 7 day set infusion set, entering Phase 2. Receives: Device: 7 day infusion set |
| Trial Arm B | Active comparator | 7 day set infusion set for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion systems , entering Phase 2. Receives: Device: 7 day infusion set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
- Percent of catheters reaching 4, 5, 6, 7 days use without set failure.
Measured: 8 weeks
Secondary outcomes (1)
Exploratory outcomes
- Exploratory investigation of correlation between glycemia as measured by CGM records and pressure measurements, as recorded by the insulin pump.
- Descriptive of site reactions. Pain at the infusion site device related issues (leakage, occlusion in fluid path, etc.).
- Descriptive of set failure cases: accidental pull out, adhesive tape issues, infection, erythema and/or induration.
- Descriptive of catheter explants:
- Gross examination for cannula kinking and crimping.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Jul 2017
- Primary completion30 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Dr. Jacob Ilany MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208282
- Sponsor's protocol ID
- 1.0
- Status last verified
- May 2020
- First submitted
- 19 Dec 2019
- Last updated
- 5 May 2020
- 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 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.
- ClinicalTrials.gov ID
- NCT04208282
- Acronym / sponsor ID
- 1.0
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Medtronic
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Dec 2019 (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.
The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.
Detailed description
This is a 1-center, prospective, open label randomized, crossover controlled study.
40 patients will be using 4 infusion sets (a total of 160 sets) that will serve as an exploratory pilot study to assess the SD of 7 day use for future study design.
Eligible patients meeting the enrollment and randomization criteria will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for4 sets (up to 28 days). The order will be determined by the randomization process:
- Arm 1: Quick-EWIS. First phase Quickset, second phase EWIS.
- Arm 2: EWIS-Quick. First phase EWIS, second phase Quickset.
Following screening and informed consenting to the trial, a randomized procedure will define the subject trial arm:
- Trial Arm A: Subjects will be randomized to a group who will be using the Quickset infusion system for the Phase 1. All patients will be retrained on the use of the Quickset infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the X infusion set, entering Phase 2. All patients will be trained at this visit on the use of the X EW infusion set by site staff and demonstrate proficiency in the use of the EW infusion set. After 28 days or after using 4 sets, the patients will return all the extracted catheters sets .
- Trial Arm B: Subjects will be randomized to a group who will be using the EWIS set infusion system for the initial Phase. All patients will be trained on the use of the EWIS infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion set, entering Phase 2. All patients will then be retrained on the use of the Quickset infusion set by site staff and demonstrate proficiency. After 28 days or after using 4 sets, the patients will all the extracted catheters sets .
An extension phase for additional one month (4 sets) will be conducted as a single arm to assess the seven day durability of sets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Arm A | Experimental | Device: 7 day infusion setQuickset infusion system for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the 7 day set infusion set, entering Phase 2. |
| Trial Arm B | Active comparator | Device: 7 day infusion set7 day set infusion set for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion systems , entering Phase 2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a MiniMed™ VEO pump or 640G Insulin pump with or without using an Enlite™ Sensor .
- Age 18 to 80 years
- Hemoglobin A1c level less than or equal to 10%
- Not currently known to be pregnant, nor planning pregnancy during the study.
Key exclusion criteria (3 listed)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Pregnant or lactating females
- -
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 |
|---|---|---|
| 7 day infusion set7 days survival of the sets | Device | Trial Arm A, Trial Arm B |
Primary outcome
Primary
Time frame: 8 weeks
• Percent of catheters reaching 4, 5, 6, 7 days use without set failure.
1 secondary outcome
Exploratory outcomes
Time frame: 8 weeks
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 5 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 day infusion set in people with Type1diabetes, run by Sheba Medical Center at 1 site in Israel.
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 6 inclusion and 3 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 5 May 2020. 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 Israel. 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?
Primary (time frame: 8 weeks). 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 5 May 2020.