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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Dexcom G5 Mobile Cont Glucose Monitoring Sys -PAS

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Study Status Progress Inadequate
Application Number P120005 S041/ PAS001
Date Current Protocol Accepted 01/20/2022
Study Name Dexcom G5 Mobile Cont Glucose Monitoring Sys -PAS
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 This is a prospective, observational, non-inferiority, adaptive design study intended to evaluate the safety of non-adjunctive CGM use in CGM-naïve subjects, by assessing the number of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) events with the use of CGM. The sponsor has defined SH as hypoglycemia resulting in a seizure, loss of consciousness, or requiring glucagon by a third party and DKA as requiring an emergency room (ER) visit or hospitalization.
The study includes a baseline period of 6 months using a blood glucose meter (BGM) as a comparator. Subjects will perform self-monitored blood glucose (SMBG) testing using their personal BGM. Each subject will serve as their own control defined as the subject’s first 6 months in the study with diabetes management using SMBG.
The second six months comprises the intervention period during which subjects will use CGM to manage their diabetes.
Subjects will be in the study period for approximately 12 months and will have approximately 3 clinic visits and 10 monthly telephone calls.
Study Population Description Adult and pediatric subjects, less than or equal to 2 years of age, with T1D or insulin-requiring T2D, naïve to CGM. Subpopulation enrollment is targeted for 1/3 pediatric and 2/3 adult subjects, with approximately 10% of adult participants greater than or equal to 65 years of age.
Sample Size 1038 subjects at up to 30 investigational sites in the US*
Data Collection Primary Endpoint: The primary endpoint for this clinical study is to assess change in the average number of hypoglycemic events after 6-months of CGM use compared to 6-months of BGM use.
Secondary endpoints: The secondary endpoints for this clinical study will be to assess patient reported outcomes, clinical measurements, and CGM metrics after 6-months of CGM use compared with 6-months of baseline data with BGM use.
Additional analyses include, but are not limited to the following:
Clinical Measurements
1. A1C change, overall and across the A1C range
2. Change in percentage of participants with at least one (1) hypoglycemia event
3. Change in the percentage of participants with at least one (1) diabetic ketoacidosis event
4. Percentage of participants with increased and decreased number of hypoglycemia events
5. Change in the number & proportion of hypoglycemia events stratified by day versus night
Patient Reported Outcomes
1. Glucose Monitoring Satisfaction Survey (GMSS)
2. CGM Satisfaction
3. Diabetes Distress Scale (DDS)
4. Hypoglycemia Fear Survey-Worry subscale (HFS-W)
5. Hypoglycemia Confidence
CGM Metrics-comparing Month 7 (after CGM initiated) with Month 12:
1. Average of CGM Glucose
2. Standard Deviation (SD) of CGM glucose
3. Percentage of CGM glucose within range: 70-180 mg/dL
4. Percent Time-in-Hypoglycemia (<70 mg/dL)
5. Percentage of CGM glucose in Hypoglycemia: (<55 mg/dL)
6. Percent Time-in-Hyperglycemia (>250 mg/dL)
7. Percentage of CGM glucose in Hyperglycemia (>300 mg/dL)
Other Metrics
1. CGM adherence: frequency of CGM use at month 12 compared to month 7 of CGM use
2. Change in SMBG frequency after initiation of CGM compared to baseline period, defined aa time point when BGM or CGM is established (months 3-6 for BGM and months 9-12 for CGM)
3. Change in the numbers & proportions of hypoglycemic events stratified by sensor location (used in approved wear locations or off-label)
4. A subpopulation analyses will be conducted at the end of the study, including but not limited to: Type 1 diabetes, Type 2 diabetes, adult, pediatric, and elderly.
Follow-up Visits and Length of Follow-up Subjects will be in the study period for approximately 12 months and will have approximately 3 clinic visits and monthly telephone calls (total of 10).
Interim or Final Data Summary
Interim Safety Information A total of nine hundred and five (905) participants have been enrolled in this study; the interim analysis efficacy requirement per the Stopping Rules found in the protocol for adult participants has been satisfied. Pediatric participant enrollment and potential recruitment has been slow and are not meeting expected enrollment goals.
Actual Number of Patients Enrolled 905
Actual Number of Sites Enrolled 27
Patient Follow-up Rate 722 subjects have completed the study
Study Strengths & Weaknesses Strengths: Dexcom has demonstrated that they satisfied the efficacy requirement in the adult population that CGM is non-inferior to SMBG in terms of the number of hypoglycemia events per subject when used non-adjunctively.
Weaknesses: Pediatric enrollment is slower than anticipated.

Dexcom G5 Mobile Cont Glucose Monitoring Sys -PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/20/2017 07/27/2017 Overdue/Received
one year report 12/20/2017 12/21/2017 Overdue/Received
18 month report 06/20/2018 06/22/2018 Overdue/Received
two year report 12/20/2018 12/26/2018 Overdue/Received
three year report 12/20/2019 12/18/2019 On Time
four year report 12/19/2020 12/11/2020 On Time
5 year report 12/19/2021 12/17/2021 On Time
6 year report 12/20/2022    

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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