FSL2 Post Approval Study for Pediatric and Young Adults Patients

Eligibility Criteria

• 1. Subject must be 4 - 30 years of age.
• 2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
• 3. Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes.
• 4. Subject has completed participation in clinical study ADC-US-PMS-20194 or has at least six (6) months of medical history hypoglycemia or hyperglycemia requiring healthcare professional intervention.
• 5. Subject and/or caregiver must be able to read and understand English.
• 6. In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
• 7. Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.
• 8. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
• 9. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• 10. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
• 11. Subject is on dialysis at the time of enrollment.
• 12. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
• 13. Subject currently is participating in another clinical trial.
• 14. Subject is unsuitable for participation due to any other cause as determined by the Investigator.