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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428762
Recruitment Status : Withdrawn (we decided to change the protocol completely to an RCT.)
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Sheba Medical Center
Kaplan Medical Center
Soroka University Medical Center
Wolfson Medical Center
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment Phase
T1DM Device: I-Port Advance use Not Applicable

Detailed Description:
study withdrawn Nor relevant

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

This is a multi-center,2 parts study:

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

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

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



Primary Outcome Measures :
  1. Life quality and satisfaction measures [ Time Frame: 3 months from patient first enrollment ]
    Life quality measure before and after I-Port Advance use by questionnaire

  2. Adverse effect [ Time Frame: 3 months from patient first enrollment ]
    Assessing Adverse effect while using I-port


Secondary Outcome Measures :
  1. Glycemic control evaluation [ Time Frame: 3 months from patient first enrollment ]
    HbA1C% before and after 3 month use of I-port advance



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT04428762    
Other Study ID Numbers: 0100-18-ASF
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes