Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM
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|ClinicalTrials.gov Identifier: NCT04428762|
Recruitment Status : Withdrawn (we decided to change the protocol completely to an RCT.)
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
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 .
|Condition or disease||Intervention/treatment||Phase|
|T1DM||Device: I-Port Advance use||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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)|
|Primary Purpose:||Supportive Care|
|Official Title:||Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment|
|Actual Study Start Date :||May 1, 2020|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
|Experimental: I-Port use arm||
Device: I-Port Advance use
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.
|No Intervention: Regular injection arm|
- 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
- Adverse effect [ Time Frame: 3 months from patient first enrollment ]Assessing Adverse effect while using I-port
- Glycemic control evaluation [ Time Frame: 3 months from patient first enrollment ]HbA1C% before and after 3 month use of I-port advance