Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM

Study Overview
=================
Brief Summary
-----------------
This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The outcomes of interest are the feasibility and potential metabolic benefits of this approach. We anticipate that the initiation of this CSII device in the immediate post-diagnosis period in this population will result in good glycemic control and greater parental satisfaction when compared to intensive insulin injection therapy.

Detailed Description
-----------------
The incidence of type 1 diabetes (T1DM) is on the rise worldwide, especially in children younger than six years of age. Glycemic control using multiple daily injection (MDI) therapy can be difficult to achieve and maintain in the very young, especially in the immediate post-diagnosis period. This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The outcomes of interest are the feasibility, safety, and potential metabolic benefits of this approach. We will recruit 14 pediatric patients, aged one to ten years, from a pool of all children newly diagnosed with T1DM admitted to the Children's Hospital of Alabama to use the pump.General diabetes education and CSII-specific training will take place in a series of outpatient sessions with the PI and study nurse. Pump therapy will be initiated within two months of diagnosis providing that all requisite education and training has been successfully completed. Data will be collected for both study group and control group patients for six months via phone calls and monthly clinic visits. Areas which will be evaluated include glycemic control, residual endogenous insulin secretion, frequency of severe adverse events, parental distress, insulin needs, and physical growth. While initiating CSII in the immediate post-diagnosis period in this population may be initially time-intensive, it is anticipated that it will ultimately become time-saving because of the greater ease in blood sugar management.

Official Title
-----------------
Fast Track Continuous Subcutaneous Insulin Infusion (CSII) in Children With Newly Diagnosed Type 1 Diabetes Mellitus: An Evaluation of a Novel CSII Device in the Immediate Period Following Diagnosis of Type 1 Diabetes (T1DM)

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Omnipod Insulin Management System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 1 through 10 years of age Patients present to the Children's Hospital of Alabama with a new diagnosis of type 1 diabetes Patients may be admitted to the inpatient unit OR from the ER OR or from an outside facility to Children's Hospital Or seen in our outpatient clinic for the first time having been diagnosed at an outside facility If patients are recruited from the outside facility in our outpatient clinic, the diagnosis must have been made within two weeks of the visit. Twenty patients and twenty control subjects will be recruited over a six-month period. Exclusion Criteria: Patients with diabetes due to other causes (neonatal diabetes, pancreatitis, cystic fibrosis, etc.) Patients will younger than 2 years of age Patients older than 8 years of age Lack any presence of other systemic disease(s), such as neoplastic disease or renal failure. Patients must have adequate parental support and stable home environment (e.g. children in foster care or with a history of suspected abuse or neglect would be excluded).

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omnipod Device<br>Patients will be placed on an Omnipod insulin pump | Device: Omnipod Insulin Management System<br>* Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus<br>* Other names: Tubeless insulin pump;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glycated Hemoglobin (A1c) | Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%. | 6.9 months (average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Reported Adverse Events | adverse events are defined as a change from baseline | 6.9 months (average) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, CSII, diabetes, C-peptide, adverse events