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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 Completed
522 Number / Requirement Number PS190006 / PSS001
Date Original Plan Accepted 04/30/2020
Date Current Plan Accepted 03/24/2022
Study Name Postmarket Surveillance Study
Device Name Control-iq, algorithm
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 Objectives 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 Assessment
Children: 6-13 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults): 18-21 yrs, Adult: >21
Sample Size Overall sample size remains unchanged. Enrollment targets changed from 193 to 163 for the 6-9 years old cohort, and
from 58 to 18, for the 6-13 years old cohort who are CGM naïve.
Key Study Endpoints 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.
Follow-up Visits and Length of Follow-up Agree to provide HbA1c result,
obtained within the 6-month period prior to enrollment”. Participants will be considered screen failures if Control-IQ data has not been downloaded to t:connect 120 days after the baseline survey's completion.
Interim or Final Data Summary
Interim Results There is a reduction in the reported rate of severe hypoglycemia events from 13.15 to 11.63 per 100 patient-years but an increase in diabetes ketoacidosis events from 1.02 to 1.42 per 100 patient-years for the current reporting period. There is no evidence that the auto-population of CGM values into the bolus calculator results in the calculation of insulin boluses that are less safe than boluses delivered not using the auto-population feature. There were no Unanticipated Adverse Device Effects.
Actual Number of Patients Enrolled 2726
Actual Number of Sites Enrolled 1
Patient Followup Rate Total number of subjects reaching each designated study phase:
o 1-month survey: 1,868
o 2-month survey: 2114
o 3-month survey: 2185
o 4-month survey: 2240
o 5-month survey: 2216
o 6-month survey: 2161
o 7-month survey: 2103
o 8-month survey: 2,118
o 9-month survey: 2,103
o 10-month survey: 2,022
o 11-month survey: 1712
o 12-month survey: 1715
Study Strengths and Weaknesses Strengths: Tandem has met their overall enrollment goals.
Weaknesses: The study population enrolled to date is predominantly White.


Postmarket Surveillance Study Reporting Schedule

Reporting 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
1 year report 04/30/2021 05/04/2021 Overdue/Received
15 month report 07/30/2021 08/06/2021 Overdue/Received
18 month report 10/30/2021 11/01/2021 Overdue/Received
21 month report 01/30/2022 02/02/2022 Overdue/Received
27 month report 07/29/2022 07/26/2022 On Time
39 month report 07/31/2023 07/31/2023 On Time
final report 09/30/2023 10/18/2023 Overdue/Received


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