Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04421001 |
| Other study ID # |
0075-20-ASF |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2020 |
| Est. completion date |
October 2022 |
Study information
| Verified date |
March 2020 |
| Source |
Assaf-Harofeh Medical Center |
| Contact |
Marianna Rachmiel, Proff |
| Phone |
+972537346636 |
| Email |
rmarianna[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 . Treatment goals include several parameters; keeping glucose levels in target
range for longer than 70% of the time, having less than 1% of hypoglycemic episodes, and
maintaining HbA1c less than 7.5%. In the pediatric population, growth parameters, and quality
of life are of major importance in addition. Studies published worldwide in the past decade
indicate that only 37% of the diabetic population achieve glycemic control target are
balanced with the objective of the glycated hemoglobin (HbA1c) below 7.5%, in all suggested
regimens. One of the major obstacles for achieving target goals is the postprandial
hyperglycemia. Post prandial hyperglycemia is related to the timing of insulin administration
and to the amount injected according to carbohydrate content of the meal A significant
association has been demonstrated between missed insulin boluses prior to meals and glycemic
control parameters 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 reason for those recommendations is based on quality of life consideration,
increasing adherence to management by less daily painful injections. According to ISPAD
recommendations, when using injections, it is suggested to consider the use of a device as
Insuflon (Unomedical) or I-Port (Medtronic) in order to decrease pain, and enable flexibility
of boluses13.
The I-Port system (Medtronic) is intended to allow insulin delivery through the port for 72
hours after port insertion, with one injection, without additional injections or pain. Any
insulin, including several types of insulin is delivered via the same port by using the
standard insulin pens. The use of I-port system may solve the obstacle of multiple painful
daily injections at disease diagnosis, may enable pre-meal administration of insulin before
meals and snacks, may improve quality of life, and most important, may decrease post prandial
glucose excursions. Moreover, one should remember that children cannot decide on the amount
of food prior to meal, and may need for achieving post prandial glucose in range 2 injections
for each meal, one before and addition after a meal, which is hard to adhere with injections.
Furthermore, toddlers receive the insulin injections after meals from fear of not finishing
the meal, thus increasing significantly their post meal glycemic excursion . 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. Previous report with Insuflon (Unomedical) showed an improvement of 0.7% in HbA1c
, as well as a low rate of pain, a local response, and no blockage15, but its use is not
common in the daily life of the patients in light of lack of comfort in insertion, and
permission to use only one insulin type. The I-port is easier to insert and can be used in
several types of insulin. The device is effective in adult population, approximately 70% to
reduce the pain, about 70% improving quality of life and 70% of patients not felt in its
presence, no change in HbA1c16. Its main side effect is 4% of the reported cases of local
reactions16.There are no reports in the literature of the use of I-port in the pediatric
population.
Technology in T1D has actually provided a solution for those multiple daily injections, by
using an insulin pump 17. However, insulin pump cannot be used immediately, and not by all
patients, and is not funded in many countries. Even in developed countries,asIsrael, it takes
a minimum of 3 months for a patient to start using a pump in real life due to health care
approvals, financial considerations, technology introduction to families, and education for
the life with T1D. However, early control of glucose levels and prevention of hyperglycemic
excursions was proven to prevent short and long term complications, and may lead to better
long-run glycemic control .
The hypothesis is that early introduction of an I-port system, as permanent means for insulin
administration, or as a bridge for future pump management, may be a simple solution in real
life for multiple injections, maintaining glucose in target range and prevention of
post-prandial glycemic excursions.
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.
To compare the number of daily insulin injections, total daily insulin dose per kg, glycemic
parameters, safety of administration and quality of life between multiple subcutaneous
insulin injections with and without iPORT in children and adolescents with recent -onset type
1 diabetes .
Research template:
A multi-center, open label, randomized controlled clinical trial. Patients will be recruited
during the first 4 weeks of diagnosis, for a study duration of 2 months.
Computerized randomization of patients will be performed to allocate them to the I-port and
control groups, at a 2:1 ratio.
Use of I-port will be demonstrated and inserted for the first time to the I-port group by a
diabetes nurse according to manufacture guidelines Patients will be instructed to administer
insulin prior to each meal or snack according to carbohydrate counting or sliding scale.
Patients will be instructed to always use an insulin cap attached to their insulin pen
Patients will use Libre continuous glucose monitoring system, as per clinical 2019
guidelines, for glucose monitoring Questionnaires regarding quality of life, treatment
satisfaction and degree of pain and discomfort will be filled at end of study All
participants allocated to the control group will have the opportunity to use I-port for 2
months at end of study, with no cost.
All study equipment, including insulin caps and activity tracker will remain at participants
possession at end of study.
Research duration:
The study is anticipated to last approximately 24 months from first investigational center
initiation to finalization of all data entry and monitoring procedures. Subject participation
is expected to be approximately of 60 days.
Study population:
The study population will include 35 patients (according to sample size calculation, as
described below) aged 1-18 years with type 1 diabetes
Non-investigational Additional Devices:
1. Abbott Libre Flash Glucose Monitoring
https://www.diabetescare.abbott/worldwide-locations.html
2. Dexcom CGM sensor system https://www.dexcom.com/get-started-cgm/ Both systems are
continuous glucose monitoring systems, used for clinical care according to guidelines
and ministry of health approved devices for T1D management since January 2020 or all
T1DM patients
3. Smart Insulin Pen Cap - Clipsulin™* (Diabnext) to capture by bluetooth connecter all
administered insulin doses including their time and dose, and food if logged in. This is
the only current novel mean available to capture real time accurate insulin
administration by patients. All data will be collected by an app. We will use in this
study a device DiabNext Clipsulin: https://www.diabnext.com/clipsulin-c3/
2. Fitbit™* Fitness Tracker or Apple Watch™* HealthKit™. An activity tracker, which will be
used in order to catch movement according to food, and insulin administration. This is not a
medical device, looks like a watch.
