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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-PAS of TS Feat. w Sensor-Augment Pump Sys


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General
Application Number P120010 / PAS001
Current Plan Approved 09/18/2015
Study Name OSB Lead-PAS of TS Feat. w Sensor-Augment Pump Sys
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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, race, body mass index (BMI), gender, diabetes classification, duration of diabetes, and hypoglycemia awareness.



Inclusion Criteria:

1. Subject is aged 16 or older at time of screening.

2. Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.

3. Subject is currently on pump therapy.

4. Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.

4. Subject is willing to complete all study related activities.

5. Subject is willing to upload data every 21 days from the study pump.

6. Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend¿s computer system with Internet access.

7. Subject is able (by insurance or financial means) to cover the

initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.



Exclusion Criteria:

1. Subject is actively participating in an investigational study (drug

or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks.

2. Subject is a woman of child-bearing potential who has a

positive pregnancy test at screening or plans to become pregnant during the course of the study

3. Subject is being treated for hyperthyroidism at time of screening

4. Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit

5. Subject has an abnormality (out of reference range) in thyroid- stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.

6. Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study

7. Subject is currently abusing illicit drugs

8. Subject is currently abusing prescription drugs

9. Subject is currently abusing alcohol

10. Subject has sickle cell disease or hemoglobinopathy

11. Subject has received red blood cell transfusion or

erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation

12. Subject diagnosed with current eating disorder such as

anorexia or bulimia

13. Subject has been diagnosed with chronic kidney disease that results in chronic anemia

14. Subject is on dialysis

Sample Size Investigational centers (50 sites) will be activated 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%).
Data Collection 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, race, baseline BMI, gender, diabetes classification, duration of diabetes, hypoglycemiac unawareness, questionnaire, 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.
Follow-up Visits and Length of Follow-up 12 months



There will be a total of 6 visits (Enrollment visit 0, Baseline visit 1 ¿ screening, visit 2 ¿ Day 90, visit 3 ¿ day 180, visit 4 ¿ day 270, visit 5 ¿ day 365).



OSB Lead-PAS of TS Feat. w Sensor-Augment Pump Sys Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
four month report 03/27/2014 01/26/2014 On Time
eight month report 06/13/2014 06/13/2014 On Time
one year report 10/17/2014 10/20/2014 Overdue/Received
18 month report 03/27/2015 03/26/2015 On Time
two year report 09/26/2015 09/25/2015 On Time
30 month report 03/18/2016 03/18/2016 On Time
three year report 09/25/2016 09/21/2016 On Time
four year report 09/25/2017    
five year report 09/25/2018    
final report 10/25/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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