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

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ClinicalTrials.gov Identifier: NCT00476788
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : January 24, 2011
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: Omnipod Insulin Management System

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2007
Primary Completion Date : August 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mean Glycated Hemoglobin (A1c) [ Time Frame: 6.9 months (average) ]
    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%.


Secondary Outcome Measures :
  1. Number of Reported Adverse Events [ Time Frame: 6.9 months (average) ]
    adverse events are defined as a change from baseline


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Stalvey, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00476788     History of Changes
Other Study ID Numbers: X060928006
First Posted: May 22, 2007    Key Record Dates
Results First Posted: January 24, 2011
Last Update Posted: April 17, 2017
Last Verified: March 2017

Keywords provided by Michael Stalvey, MD, 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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs