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

Type 1 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476788
• Other study ID #: X060928006
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: December 20, 2010
• Start date: April 2007
• Est. completion date: September 2009

Study information

• Verified date: December 2010
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 8 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Omnipod Insulin Management System
Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus

Locations

Country	Name	City	State
United States	Children's Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c	Measure of glycemic control over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.	6.9 months (average)	No
Secondary	Adverse Event Frequency		6.9 months (average)	Yes