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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OIR Lead-Post-Approval Study


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General
Study Status Progress Adequate
Application Number P120005 S041/ PAS001
Date Current Protocol Accepted 05/22/2017
Study Name OIR Lead-Post-Approval Study
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
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 Design Description The study objective is to evaluate the safety of non-adjunctive use of the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System relative to the use of glucose meters. This is a one-year prospective cross-over study in which all subjects will use a glucose meter (SMBG arm) for a 6 month period followed by 6 months of using the Dexcom G5 Mobile System (CGM arm); all subjects will be naïve CGM users or may have used professional CGM.
Study Population Description The study population comprises persons 2 years of age and older with Type 1 Diabetes or insulin-requiring Type 2 Diabetes. Eligible participants may be either naïve to CGM or may have used professional CGM. Enrollment is targeted for 1/3 pediatrics and 2/3 adults, with approximately 10% participants 65 years of age or older. Each participant will serve as their own control, with the control period defined as the participant’s first 6 months of diabetes management during the study using a glucose meter for self-monitoring of blood glucose testing.
Sample Size 1110 participants are required to demonstrate non-inferiority of CGM to SMBG, using a non-inferiority margin of 10%, with 80% power and a significance level of 0.0197 (using a final alpha of 0.0197 to yield an overall significance level of 0.025, adjusted for a single interim analysis). This assumes a CGM effect of a 10 % decrease in the Hypo rate, a standard baseline Hypo rate of 1.2 events per patient per 6 months, an over-dispersion factor of 3, and an intra-patient correlation of 0.2.

Up to 1388 participants (or more depending on the sample size re-estimation procedure) will be recruited to allow for an assumed 20% lost to follow-up.

Data Collection The primary endpoint is a change in the average number of hypoglycemic (hypo) events per patient. Hypo events include severe hypoglycemia resulting in seizure or loss of consciousness; and moderate hypoglycemia, defined as inability to self-treat due to weakness or confusion to take carbohydrates, requiring assistance by a third party. Hypoglycemia will be analyzed in aggregate (including severe and moderate hypoglycemia) as the primary analysis and separately by moderate and severe hypoglycemic events as a secondary analysis. The study evaluates various secondary endpoints including: Hemoglobin A1c, various hypoglycemia metrics, diabetic ketoacidosis (DKA) metrics, patient reported outcomes (PROs). Secondary endpoints also include specific intervention phase metrics such as CGM average glucose, CGM standard deviation, various time-in-range and time-above/below-range metrics, CGM use frequency at 6 months vs. 1 month, and change in SMBG frequency. The study protocol also specifies various subpopulation analyses including: subjects with Type 1 Diabetes, with Type 2 diabetes, adults, pediatrics, elderly subjects, and for different sensor wear locations.
Follow-up Visits and Length of Follow-up Subjects will be followed monthly throughout the 12 month study. There is no planned follow-up for subjects once they complete their final clinic visit.


OIR Lead-Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/20/2017 07/27/2017 Overdue/Received
one year report 12/20/2017    
18 month report 06/20/2018    
two year report 12/20/2018    
three year report 12/20/2019    
four year report 12/19/2020    
five year report 12/19/2021    


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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