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

NCT ID: NCT04428762

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-05-01

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study withdrawn Nor relevant

Conditions

T1DM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

I-Port use arm

Group Type: EXPERIMENTAL

I-Port Advance use

Intervention Type: 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.

Regular injection arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 -

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Kaplan Medical Center

OTHER

Sponsor Role: collaborator

Soroka University Medical Center

OTHER

Sponsor Role: collaborator

Wolfson Medical Center

OTHER_GOV

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0100-18-ASF

Identifier Type: -

Identifier Source: org_study_id