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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Postmarket Surveillance Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS190006 / PSS001
Date Current Plan Accepted 08/25/2020
Study Name Postmarket Surveillance Study
Root Document Number DEN190034 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This postmarket surveillance study is a single-arm, prospective study. It is designed to assess 12-month safety in a real-world setting, and to

support the continued assessment of the Control-IQ System for the treatment of type 1 diabetes in the United States. In addition, data

will be collected to assess glycemic outcomes and user experience.
Study Population Description Assessment

Children: 6-13 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults): 18-21 yrs, Adult: >21

Sample Size

The study will recruit a minimum of 2,063 subjects. For the primary safety endpoints, the projected total recruitment sample size of 2,063 subjects (including 25% attrition) would provide 80% power with a 2-sided type 1 error rate of 5%. With attrition, it is expected that 1,547 subjects will complete the study. Recruitment goals for study subgroups will include:

• At least 385 subjects in the 6 to 13 year-old cohort, and at least 328 subjects in the 14 to =18 year-old cohort. Depending on the rate of recruitment in these two age groups, the balance of the 2,063 subjects will be recruited from the >18 year-old subgroup.

• Of the 6-13 year old cohort:

o At least half (n=193) will be 6-9 years old

o At least 25% (n=96) will have a baseline A1c = 8.5%

o At least 25% (n=96) will be pump naïve

o At least 15% (n=58) will be CGM naïve. This percentage is based on clinical evidence of high baseline CGM use in this age group. Recruitment of CGM-naïve children in our previous clinical trial did not achieve the pre-specified target of 20%.

• Of the >14 year old cohort,

o Approximately 677 subjects each in the pump user and pump naïve subgroups at baseline.

o Approximately 270 subjects that are CGM naïve (defined as not using CGM in the 30 days prior to enrollment).

o Approximately 681 subjects (33% of total sample) with HbA1c =8.5% and 681 subjects (33% of total sample) in the <8.5% subgroup



Data Collection Safety Endpoints:

1. The composite rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and

2. The safety of the automatic population of CGM readings the bolus calculator of the Control-IQ System

Secondary Endpoints:

3. To determine glycemic outcomes as a measure of efficacy of the Control-IQ System, and

4. To demonstrate patient-reported satisfaction with and trust in the Control-IQ System, usability of the system, and sleep

quality.


Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 07/30/2020 07/30/2020 On Time
6 month report 10/30/2020 11/03/2020 Overdue/Received
9 month report 01/30/2021 02/01/2021 Overdue/Received
one year report 04/30/2021 05/04/2021 Overdue/Received
15 month report 07/30/2021    
18 month report 10/30/2021    


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