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

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 .

Study Overview

• Status: Withdrawn
• Conditions: T1DM
• Intervention / Treatment: Device: I-Port Advance use

Detailed Description

study withdrawn Nor relevant

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Tel-Aviv Sourasky Medical Center; Sheba Medical Center; Wolfson Medical Center; Kaplan Medical Center; Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0100-18-ASF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes