RCT for Evaluation of Insulin Administration, Time in Range of Glucose, Adverse Events and Quality of Life, While Using the iPORT System in Pediatric Population With Recent-onset Type 1 Diabetes

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: