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

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00476788
First received: May 18, 2007
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Device: Omnipod Insulin Management System

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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • A1c [ Time Frame: 6.9 months (average) ] [ Designated as safety issue: No ]
    Measure of glycemic control over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.


Secondary Outcome Measures:
  • Adverse Event Frequency [ Time Frame: 6.9 months (average) ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omnipod Device
Patients will be placed on an Omnipod insulin pump
Device: Omnipod Insulin Management System
Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
Other Name: Tubeless insulin pump

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.

  Eligibility

Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476788

Locations
United States, Alabama
Children's Hospital
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Elaine C Moreland, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Elaine Moreland MD, UAB
ClinicalTrials.gov Identifier: NCT00476788     History of Changes
Other Study ID Numbers: X060928006
Study First Received: May 18, 2007
Results First Received: October 12, 2010
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
pediatrics
CSII
diabetes
C-peptide
adverse events

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014