Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM

Study Overview
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Brief Summary
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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
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study withdrawn Nor relevant

Official Title
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Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment

Conditions
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T1DM

Intervention / Treatment
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* Device: I-Port Advance use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. - Exclusion Criteria: Insulin pump use Mix insulin use -

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-Port use arm<br> | Device: I-Port Advance use<br>* 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.<br>|
| No Intervention: Regular injection arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality and satisfaction measures | Life quality measure before and after I-Port Advance use by questionnaire-delta of score | 3 months from patient first enrollment | 
| Adverse effect | Number of Adverse effect while using I-port-clinical | 3 months from patient first enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control evaluation | HbA1C% before and after 3 month use of I-port advance | 3 months from patient first enrollment |