In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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 Description
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
Data Collection
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.
Followup Visits and Length of Followup
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.
Final Study Results
Actual Number of Patients Enrolled
78
Actual Number of Sites Enrolled
4
Patient Followup 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.
Study Strengths and Weaknesses
Strength: The study was designed as a randomized controlled trial.
Recommendations for Labeling Changes
There were no recomendations made for labeling changes.
