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

NCT04428762 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-10

No results posted yet for this study

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. 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 .

Conditions

  • T1DM

Interventions

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.

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Kaplan Medical Center

    collaborator OTHER

  • Soroka University Medical Center

    collaborator OTHER

  • Wolfson Medical Center

    collaborator OTHER_GOV

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428762 on ClinicalTrials.gov