NCT00476788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 24, 2011

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

May 18, 2007

Results QC Date

October 12, 2010

Last Update Submit

March 20, 2017

Conditions

Type 1 Diabetes Mellitus

Keywords

pediatricsCSIIdiabetesC-peptideadverse events

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Reported Adverse Events

    6.9 months (average)

Study Arms (1)

Omnipod Device

EXPERIMENTAL

Patients will be placed on an Omnipod insulin pump

Device: Omnipod Insulin Management System

Interventions

Omnipod Insulin Management SystemDEVICE

Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus

Also known as: Tubeless insulin pump
Omnipod Device

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Elaine Moreland MD
Organization
Greenville Hospital System
emoreland@ghs.org
8644545661

Study Officials

  • Elaine C Moreland, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

April 17, 2017

Results First Posted

January 24, 2011

Record last verified: 2017-03

Locations

US(1)