T1DMNCT04428762
Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM
A study testing I-Port Advance use in people with T1DM, run by Assaf-Harofeh Medical Center.
Trial summary
The incidence of T1DM in children, especially infants under 4 years of age, is increasing in the last decade. Not all patients are willing or able, from different reasons, to be treated with insulin pumps. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- T1DM
- What is being tested?
- I-Port Advance use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 May 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with type 1 diabetes mellitus
- Insulin injection ≥2 per day for at least a week.
- Use of MDI insulin: Novorapid, Humalog or Apidra.
- Ability and willingness to perform at least 3 daily self-measured plasma glucose profiles
- Ability and willingness to adhere to the protocol. -
Who cannot join
- Insulin pump use
- Mix insulin use -
About this study
Official title: Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment
The incidence of T1DM in children, especially infants under 4 years of age, is increasing in the last decade. Not all patients are willing or able, from different reasons, to be treated with insulin pumps. This portion of patients' needs subcutaneous insulin injections, at lest 4 injections per day, sometimes up to 8 injections per day.
The recommended treatment is insulin injection before each carbohydrate content meal. Since each injection may lead to pain, many patients do not inject all recommended doses. The solution could be: eat with no bolus, or not to correct glucose level to retrain from pain sensation. I-Port use is able to address this issue by reducing the pain sensation accompanied with the injection. I-Port advance may give a technological solution to non-insulin pump T1DM pediatric patients.
Read more
There are no reports in the literature of the use of iport in children and youth. This information is essential since 95% of pediatric diabetes mellitus cases are insulin dependent and require multiple injections. Better balanced diabetes in childhood may prevent complications to long range and long-term diabetes therapy. Moreover, if discovered safe, the iport can be used also for other subcutaneously delivered medication in children, such as somtostatin analog, human growth hormone and clexane Study is designed as 2 parts. Initial part is a cross over design to compare between ipor use an injections regarding glucose in range, side effects and quality of life.
Second part is designed as prospective. To assess glycemic control with iport use or 3 months .
Read the detailed description
study withdrawn Nor relevant
- Conditions
- T1DM
- Being tested
- I-Port Advance use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-Port Advance useDevice
participants will apply I-port advance for 4 weeks and will inject all insulin through the port. follow up 3 months with/ without i-port.
| Study group | Role | What they receive |
|---|---|---|
| I-Port use arm | Experimental | Not described Receives: Device: I-Port Advance use |
| Regular injection arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality and satisfaction measures
Life quality measure before and after I-Port Advance use by questionnaire-delta of score
Measured: 3 months from patient first enrollment
Adverse effect
Number of Adverse effect while using I-port-clinical
Measured: 3 months from patient first enrollment
Secondary outcomes (1)
Glycemic control evaluation
HbA1C% before and after 3 month use of I-port advance
Measured: 3 months from patient first enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 May 2020
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: we decided to change the protocol completely to an RCT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DMStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multi-center,2 parts study: the first part: randomized crossover study second part: prospective follow-up study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Sheba Medical Center, Kaplan Medical Center, Soroka University Medical Center, Wolfson Medical Center, Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428762
- Sponsor's protocol ID
- 0100-18-ASF
- Status last verified
- Aug 2022
- First submitted
- 3 Jul 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment
- ClinicalTrials.gov ID
- NCT04428762
- Acronym / sponsor ID
- 0100-18-ASF
- Conditions
- T1DM
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we decided to change the protocol completely to an RCT.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Sheba Medical Center, Kaplan Medical Center, Soroka University Medical Center, Wolfson Medical Center, Tel-Aviv Sourasky Medical Center
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 Jun 2020 (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 incidence of T1DM in children, especially infants under 4 years of age, is increasing in the last decade. Not all patients are willing or able, from different reasons, to be treated with insulin pumps. This portion of patients' needs subcutaneous insulin injections, at lest 4 injections per day, sometimes up to 8 injections per day.
The recommended treatment is insulin injection before each carbohydrate content meal. Since each injection may lead to pain, many patients do not inject all recommended doses. The solution could be: eat with no bolus, or not to correct glucose level to retrain from pain sensation. I-Port use is able to address this issue by reducing the pain sensation accompanied with the injection. I-Port advance may give a technological solution to non-insulin pump T1DM pediatric patients.
There are no reports in the literature of the use of iport in children and youth. This information is essential since 95% of pediatric diabetes mellitus cases are insulin dependent and require multiple injections. Better balanced diabetes in childhood may prevent complications to long range and long-term diabetes therapy. Moreover, if discovered safe, the iport can be used also for other subcutaneously delivered medication in children, such as somtostatin analog, human growth hormone and clexane Study is designed as 2 parts. Initial part is a cross over design to compare between ipor use an injections regarding glucose in range, side effects and quality of life.
Second part is designed as prospective. To assess glycemic control with iport use or 3 months .
Detailed description
study withdrawn Nor relevant
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multi-center,2 parts study: the first part: randomized crossover study second part: prospective follow-up study
| Arm | Type | Receives |
|---|---|---|
| I-Port use arm | Experimental | Device: I-Port Advance use |
| Regular injection arm | No intervention | – |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with type 1 diabetes mellitus
- Insulin injection ≥2 per day for at least a week.
- Use of MDI insulin: Novorapid, Humalog or Apidra.
- Ability and willingness to perform at least 3 daily self-measured plasma glucose profiles
- Ability and willingness to adhere to the protocol. -
Key exclusion criteria (2 listed)
- Insulin pump use
- Mix insulin use -
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 |
|---|---|---|
| I-Port Advance useparticipants will apply I-port advance for 4 weeks and will inject all insulin through the port. follow up 3 months with/ without i-port. | Device | I-Port use arm |
Primary outcome
Life quality and satisfaction measures
Time frame: 3 months from patient first enrollment
Life quality measure before and after I-Port Advance use by questionnaire-delta of score
Adverse effect
Time frame: 3 months from patient first enrollment
Number of Adverse effect while using I-port-clinical
1 secondary outcome
Glycemic control evaluation
Time frame: 3 months from patient first enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing I-Port Advance use in people with T1DM, run by Assaf-Harofeh Medical Center.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Life quality and satisfaction measures (time frame: 3 months from patient first enrollment). The study lists 2 primary outcomes in all. 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 10 Aug 2022.