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Trial record 96 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):
Michael Stalvey, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Intervention Device: Omnipod Insulin Management System
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omnipod Device
Hide Arm/Group Description Patients will be placed on an Omnipod insulin pump
Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Arm/Group Title Omnipod Device
Hide Arm/Group Description Patients will be placed on an Omnipod insulin pump
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
14
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
6.275  (2.875)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Mean Glycated Hemoglobin (A1c)
Hide Description 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%.
Time Frame 6.9 months (average)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omnipod Device
Hide Arm/Group Description:
Patients will be placed on an Omnipod insulin pump
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percentage of glycated hemoglobin
7.6  (1.0)
2.Secondary Outcome
Title Number of Reported Adverse Events
Hide Description adverse events are defined as a change from baseline
Time Frame 6.9 months (average)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omnipod Device
Hide Arm/Group Description:
Patients will be placed on an Omnipod insulin pump
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: events
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omnipod Device
Hide Arm/Group Description Patients will be placed on an Omnipod insulin pump
All-Cause Mortality
Omnipod Device
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Omnipod Device
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omnipod Device
Affected / at Risk (%)
Total   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elaine Moreland MD
Organization: Greenville Hospital System
Phone: 8644545661
Responsible Party: Michael Stalvey, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00476788     History of Changes
Other Study ID Numbers: X060928006
First Submitted: May 18, 2007
First Posted: May 22, 2007
Results First Submitted: October 12, 2010
Results First Posted: January 24, 2011
Last Update Posted: April 17, 2017