Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
This study has been completed.
Sponsor:
University of Alabama at Birmingham
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
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Results First Received: October 12, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Type 1 Diabetes Mellitus |
| Intervention: |
Device: Omnipod Insulin Management System |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Omnipod Device | Patients will be placed on an Omnipod insulin pump |
Participant Flow: Overall Study
| Omnipod Device | |
|---|---|
| STARTED | 14 |
| COMPLETED | 11 |
| NOT COMPLETED | 3 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Omnipod Device | Patients will be placed on an Omnipod insulin pump |
Baseline Measures
| Omnipod Device | |
|---|---|
|
Number of Participants
[units: participants] |
14 |
|
Age
[units: participants] |
|
| <=18 years | 14 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
6.275 ± 2.875 |
|
Gender
[units: participants] |
|
| Female | 7 |
| Male | 7 |
|
Region of Enrollment
[units: participants] |
|
| United States | 14 |
Outcome Measures
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
Reporting Groups
| Description | |
|---|---|
| Omnipod Device | Patients will be placed on an Omnipod insulin pump |
Other Adverse Events
| Omnipod Device | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 0/0 |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Elaine Moreland MD
Organization: Greenville Hospital System
phone: 8644545661
e-mail: emoreland@ghs.org
Organization: Greenville Hospital System
phone: 8644545661
e-mail: emoreland@ghs.org
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 |