Glycemic Control and Quality of Life With i- Port Advance... | NCT04428762

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

NCT04428762

Sponsor

Assaf-Harofeh Medical Center

Status

Withdrawn

Last Update Posted

Aug 10, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

T1DM

Interventions

I-Port Advance use

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

we decided to change the protocol completely to an RCT.

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Jul 3, 2019

First Submission Date that Met QC Criteria

Jun 10, 2020

First Posted Date

Jun 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2022

Last Update Posted Date

Aug 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Assaf-Harofeh Medical CenterOTHER_GOV

Collaborators

Name	Class
Sheba Medical Center	OTHER_GOV
Kaplan Medical Center	OTHER
Soroka University Medical Center	OTHER
Wolfson Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I-Port use arm	Experimental		Device: I-Port Advance use
Regular injection arm	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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. -

Exclusion Criteria:

Insulin pump use
Mix insulin use -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Intervention Model Description

This is a multi-center,2 parts study:

the first part: randomized crossover study second part: prospective follow-up study