RCT for Evaluation of Insulin Administration,While Using the iPORT System

NCT04421001 | Unknown

• 1 other identifier: 0075-20-ASF
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 1 diabetes is the most common chronic pediatric autoimmune disease, with a rising incidence rate in recent years around the world and in Israel Management includes multiple daily capillary glucose measurements by finger pricks, or interstitial sugar measurements by sensors, and insulin subcutaneous administration before each meal by injections or by an insulin pump . The initial management and teaching of T1D patients and families includes at least 5-6 glucose measurements per day and at least 4 insulin injections per day, while the preferred guideline should be insulin administration prior to each meal, including morning and afternoon snacks, very common among pediatric patients attending school curriculum. The early use of I-port at disease diagnosis may reduces pain, increase the amount of daily injections, may increase accuracy of insulin administration, and thus improve time in range from disease diagnosis. Aims of study: To assess the efficacy of I-port use in recent onset T1D in a pediatric population, in increasing insulin administration and possibly improving time in range of glucose.

Conditions

T1DM

Outcome Measures

Primary Outcomes (2)

• Daily insulin administration per day

  The difference in number of insulin administrations per day between I-port and control groups

  2 years

• Total insulin daily dose per kg per day

  The difference in total daily insulin dose per kg per day between I-port and control groups

  2 years

Secondary Outcomes (6)

• Time in Range difference

  2 years

• hyperglycemic and hypoglycemic ranges of glucose per day

  2 years

• HbA1c

  2 years

• coefficient of variability (CV)

  2 years

• quality of life difference scale 1-46, higher is better

  2 years

Study Arms (2)

I-Port™*(Medtronic) use Arm

EXPERIMENTAL

Patients will administer insulin via iport system. I-Port™\* (Medtronic), infusion set, dedicated for insulin deliery for 72 hours.

Device: I-port use

Insulin Pen Injections

ACTIVE COMPARATOR

Patients will administer insulin via injections as usual

Device: I-port use

Interventions

I-port use DEVICE

patient will use I-port device fo 2 months

I-Port™*(Medtronic) use Arm; Insulin Pen Injections

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of type 1 diabetes within the last 4 weeks
• Need for insulin injections at least 1 times a day
• Age of 1-18 years.
• Agree to comply with all the terms of the study
• Has an iPhone, iOS 11 or higher OR Android

You may not qualify if:

• Insulin pump therapy

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Officials

• Avital Leshem

  Assaf-Harofeh Medical Center

  STUDY DIRECTOR

Central Study Contacts

Marianna Rachmiel, Proff

CONTACT

+972537346636; rmarianna@gmail.com

Avital Leshem

CONTACT

+972528303012; childendo.research@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: June 9, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share