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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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SmartAdjust Technology


 
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General
Study Status Ongoing
522 Number / Requirement Number PS220002 / PSS001
Date Original Plan Accepted 02/10/2023
Study Name SmartAdjust Technology
Device Name Insulet smartadjust
Root Document Number K203774  K220394 
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Decentralized observational clinical registry
Study Population Individuals, 2 years of age and older, with Type 1 diabetes (T1D).
Sample Size A minimum of 2,200 Type 1 participants will be recruited to ensure a
minimum of 1,650 participants completing at least 12 months of follow-up.
The minimum number of completed participants are as follows:
• 150 participants aged 2-5
• 300 participants aged 6-13
• 300 participants aged 14-17
• 900 participants aged 18+
In addition, enrollment targets for Type 1 diabetes specific populations of
interest, include a minimum of 1100 Omnipod-naïve users, 880 pump naïve
users, and 110 CGM-naïve users.
Assumptions for sample size estimation: The sponsor did not provide assumptions for sample size estimation.
Number of sites: N/A
Sites location: N/A
Key Study Endpoints Safety Endpoints
Primary:
• Incidence rate of severe hypoglycemia (events per person months)
• Incidence rate of diabetic ketoacidosis (DKA) (events per person months)
Effectiveness Endpoints
Primary: Effectiveness will be evaluated using the following per participant
endpoints as compared to baseline when available:
• A1C (at 3, 6, 9 and 12 months)
• Glycemic outcomes
o Percentage of time < 54 mg/dL
o Percentage of time < 70 mg/dL
o Percentage of time > 180 mg/dL
o Percentage of time > 250 mg/dL
o Percentage of time in range 70-180 mg/dL
o Mean glucose
o Standard deviation of glucose
o Glucose management indicator
o Percentage of participants achieving A1C <7%
o Percentage of participants with time in range >70%
o Percentage of participants with time below range (<70mg/dL) of < 4%
Insulin usage (units, units/kg)
• BMI or BMI z-score (at 6 and 12 months)
• Participant-reported outcome questionnaires at baseline, 6 months and
end of registry participation (or withdrawal from registry)
• EQ-5D (inclusive of the Visual Analogue Scale (VAS))
• Insulin Delivery Systems: Perceptions, Ideas, Reflections, and
Expectations (INSPIRE)
• System Usability Scale (SUS)
• Incidence rate of prolonged hyperglycemia (events per person
months) during usage of Activity Mode
• Incidence rate of prolonged hyperglycemia (events per person
months)
• Incidence rate of prolonged hyperglycemia (events per person
months) during usage of a Target Glucose of 140 mg/dL or 150
mg/dL
• Glucose outcomes during the 4-hour post-bolus period using the
SmartBolus Calculator:
o Percentage of time < 54 mg/Dl
o Percentage of time in range 70-180 mg
Follow-up Visits and Length of Follow-up Participants are expected to be followed for 12 months. Insulet stated that they will continue to collect safety data through their postmarket reporting after participants have completed the study.


SmartAdjust Technology Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/10/2023 08/09/2023 On Time
1 year report 02/10/2024 02/07/2024 On Time
18 month report 08/10/2024    
2 year report 02/10/2025    
3 year report 02/10/2026    
final report 06/10/2026    


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