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

T1DM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04428762
• Other study ID #: 0100-18-ASF
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2022
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 .

Description:

study withdrawn Nor relevant

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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 -

Related Conditions & MeSH terms

• T1DM

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Kaplan Medical Center, Sheba Medical Center, Soroka University Medical Center, Tel-Aviv Sourasky Medical Center, Wolfson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse effect	Number of Adverse effect while using I-port-clinical	3 months from patient first enrollment
Secondary	Glycemic control evaluation	HbA1C% before and after 3 month use of I-port advance	3 months from patient first enrollment