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

Not Applicable

Withdrawn

• Conditions: T1DM
• Interventions: Device: I-Port Advance use

• Registration Number: NCT04428762
• Lead Sponsor: Assaf-Harofeh Medical Center

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study withdrawn Nor relevant

Study Timeline

• Study First Submitted: 2019-07-03
• Study Start: 2020-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-07
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I-Port use arm	I-Port Advance use	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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