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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04428762

Enrollment

Registered

2020-06-11

Start date

2020-05-01

Completion date

2020-05-01

Last updated

2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T1DM

Brief 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 .

Detailed description

study withdrawn Nor relevant

Interventions

DEVICEI-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

This is a multi-center,2 parts study: the first part: randomized crossover study second part: prospective follow-up study

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

1. Diagnosed with type 1 diabetes mellitus 2. Insulin injection ≥2 per day for at least a week. 3. Use of MDI insulin: Novorapid, Humalog or Apidra. 4. Ability and willingness to perform at least 3 daily self-measured plasma glucose profiles 5. Ability and willingness to adhere to the protocol. -

Exclusion criteria

1. Insulin pump use 2. Mix insulin use -

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026