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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980022 S012/ PAS001 |
| Date Original Protocol Accepted |
12/27/2006
|
| Date Current Protocol Accepted |
12/27/2006
|
| Study Name |
PXX/GS041/A
|
| Device Name |
GUARDIAN RT
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a randomized controlled trial, in which one arm receives the device with human albumin serum sensor and the other arm receives the device with bovine albumin serum sensor.
|
| Study Population |
Study Population: Patients aged 18 to 65 years, previously diagnosed with type 1 diabetes, and currently using an insulin pump or multiple daily injections. Indication: The device is used in patients with diabetes as a continuous glucose monitoring system in conjunction with a standard home blood glucose meter.
|
| Sample Size |
78 patients, 4 sites
|
| Key Study Endpoints |
The clinical endpoints to be measured consist of capillary blood glucose concentration as measured by the One-Touch Ultra Meter, and glucose values calculated from sensor signals measured by the Guardian RT System. The safety endpoints consist of device effects and frequency of device complications associated with the Guardian RT System. Data collection consited of a download the continious glucose monitoring system and glucose meter data as well as interview the patient at office visits.
|
| Follow-up Visits and Length of Follow-up |
After enrollment, subjects will be followed by phone calls on day 3, day 18, and day 21. On day 30s the end of study, subjects will return all study supplies to the site, and data will be uploaded to a computer for analysis and review.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
78
|
| Actual Number of Sites Enrolled |
4
|
| Patient Follow-up Rate |
80%
|
| Final Safety Findings |
A total of five adverse events were reported across 4 subjects during the study. All reported complete recovery. Two of the subjects experienced skin disorders (rash and/or itching); one subject experienced a hypoglycemic event, which was considered severe (the subject showed complete recovery after treatment with concomitant medications); and one subject experienced a syncopal episode (subject passed out after inserting a sensor) and withdrew from the study.
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| Study Strengths & Weaknesses |
Strength: The study was designed as a randomized controlled trial.
|
| Recommendations for Labeling Changes |
There were no recomendations made for labeling changes.
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