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, 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
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%).
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.
Followup Visits and Length of Followup
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).
PAS of TS Feature w/a Sensor-Augmented Pump System