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NCT01161043 · ClinicalTrials.gov registry record · NA
New Glucose Sensor Pediatric
A NA study of Type 1 Diabetes Mellitus, sponsored by Medtronic Diabetes.
- Completed
- Registry status
- NA
- Development phase
- 83
- Enrollment target
- 4
- Study locations
NCT01161043: Completed NA study of Type 1 Diabetes Mellitus, sponsored by Medtronic Diabetes.
NCT01161043 is a NA study of Type 1 Diabetes Mellitus that has completed, run by Medtronic Diabetes. The registered enrollment target is 83 participants, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (51% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01161043, a NA study of Type 1 Diabetes Mellitus, has completed, sponsored by Medtronic Diabetes.
- COMPLETED
- Registry status
- NA
- Development phase
- 83 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance of the new sensor will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Primary Outcome
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and SMBG glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between SMBG and paired sensor (within 20 mg/dL if SMBG ≤ 80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
Conditions Studied
Interventions
- DEVICE Sensor wear
Study Locations (4)
Alabama
- University of Alabama Birmingham - Birmingham
California
- Sutter Institute for Medical Research - Sacramento
Florida
- Endocrinology/ University of South Florida - St. Petersburg
Minnesota
- University of Minnesota Amplatz Children's Hospital - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-11 |
| Phase | NA |
What the finished NCT01161043 record still lists
NCT01161043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Sensor wear is the first listed.
NCT01161043 reports a single indexed study location in Alabama, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01161043 about?
NCT01161043 is a clinical study titled "New Glucose Sensor Pediatric". The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance of the new sensor will be calculated for use of the new sensor with proposed new devices using ne...
What is the current status of trial NCT01161043?
This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2010-07. Estimated completion is 2010-11.
What conditions does trial NCT01161043 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01161043?
The interventions under investigation include: Sensor wear (DEVICE).
Who is sponsoring clinical trial NCT01161043?
This trial is sponsored by Medtronic Diabetes, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01161043 being conducted?
This trial has 4 study locations across Alabama, California, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01161043's enrollment target sits among peer trials
83 37th of 112 higher than 76 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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