title: Regulation Catches Up to Reality.
abstract: The FDA recently conducted an Advisory Panel meeting to evaluate the safety, efficacy, and benefits of granting a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system. If approved, this claim will allow users to make day-to-day treatment decisions, including insulin dosing directly from the glucose values and rate of changes arrows generated by the CGM device, without the requirement of a confirmatory measurement with a self-monitoring blood glucose (SMBG) meter. Sporadic SMBG testing gives limited data, while CGM gives a value every 5 minutes and has alerts, alarms, trending information and allows caregivers to follow the user in real time 24/7. This indication will lead to more wide spread use of CGM and improve overall care with protection of hypoglycemia.
authors.affiliation: 1 University of California San Diego, San Diego, CA, USA.
authors.forename: Steven V
authors.initials: SV
authors.lastname: Edelman
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards*; D018795:Device Approval; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: CGM; FDA panel meeting; SMBG; nonadjunctive claim