Clinical trial NCT04428762: Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM
Official title: Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: T1DM
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Sheba Medical Center
name: Kaplan Medical Center
name: Soroka University Medical Center
name: Wolfson Medical Center
name: Tel-Aviv Sourasky Medical Center
First posted: 2020-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a multi-center,2 parts study:

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

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

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 -

Primary outcomes:
measure: Life quality and satisfaction measures
timeFrame: 3 months from patient first enrollment
measure: Adverse effect
timeFrame: 3 months from patient first enrollment
Secondary outcomes:
measure: Glycemic control evaluation
timeFrame: 3 months from patient first enrollment
Other outcomes:
Locations:
Study officials:
References: