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

NCT04428762 | Withdrawn FDA Device

• 1 other identifier: 0100-18-ASF
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

T1DM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Glycemic control evaluation

  3 months from patient first enrollment

Study Arms (2)

I-Port use arm

EXPERIMENTAL

Device: I-Port Advance use

Regular injection arm

NO INTERVENTION

Interventions

I-Port Advance use DEVICE

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.

I-Port use arm

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• Insulin pump use
• Mix insulin use -

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Sheba Medical Center: collaborator
• Kaplan Medical Center: collaborator
• Soroka University Medical Center: collaborator
• Wolfson Medical Center: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: June 11, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 10, 2022

Record last verified: 2022-08