1. Guidance for Industry and Food and Drug Administration StaffThe Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Document issued on: November 9, 2012.
2. U.S. Food and Drug AdministrationPremarket approval application for the Medtronic MiniMed 670G System. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017a.pdf. Accessed Nov 30, 2017.
3. Paradigm REAL-Time Revel User Guide with Sof-sensor. Available at: http://professional.medtronicdiabetes.com/para/new-enlite-sensor. Accessed Nov 30, 2017.
4. MiniMed® 670G Insulin Pump System. Available at: https://www.medtronicdiabetes.com/products/minimed-670g-insulin-pump-system. Accessed Nov 30, 2017.
5. Dexcom® Continuous Glucose Monitoring. Available at: https://www.dexcom.com/dexcom-g4-platinum-performance. Accessed Nov 30, 2017.