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.
A longitudinal, multi-center study to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin
pump in patients 16 and older with insulin-requiring diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the Medtronic MiniMed® 530G insulin pump.
Study Population Description
Adult (16 years and older) US subjects that meet the inclusion/exclusion criteria. Subjects will be
grouped by baseline demographics: Age, ethnicity, body mass index (BMI), gender and duration of diabetes and hypoglycemic awareness.
Investigational centers (50 sites) will be selected across the United States. Up to 1,200 subjects
will be enrolled so that there will be 1,000 subjects who are eligible to participate in the study . The 1000 subject sample size was calculated based on an overall consideration of the primary hypothesis, drop-out rate (20%), compliant rate (65%), and ability to detect serious adverse events (14.5%).
Primary endpoint: The overall mean change in A1C from baseline will be estimated and compared
by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).
Secondary endpoint: The mean change in A1C from baseline to end of study for each individual A1C cohort (i.e. less than 7.0%, 7.0-9.0%, greater than 9.0%).
Safety endpoints: Serious Adverse Events (SAE), Unanticipated Device Effects (UADE), Incidence of Severe Hypoglycemia, Incidence of Severe Hyperglycemia, Incidence of Diabetic Ketoacidosis (DKA), Adverse Events will be stratified by age, ethnicity, baseline BMI, gender, duration of diabetes, hypoglycemia awareness, frequency and average duration of hypoglycemic event (based on two weeks prior to the adverse event)
Descriptive endpoints: Descriptive summary statistics will be provided for A1C Change, Hypo/Hyperglycemia Events and TS Metrics, Device Utilization, CGM Metric, Device Performance, Effectiveness of educational materials, Descriptive subgroup analysis of A1C data will be performed on demographic cohorts.
Followup Visits and Length of Followup
12 months after enrollment.
Each patient will be followed-up in 5 visits in the 12-month period,
i.e. every 90 days from the enrollment.
PAS of TS Feature w/a Sensor-Augmented Pump System