Diabetes Mellitus, Type 1 — Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.
Citation(s)
American Diabetes Association 6. Glycemic Targets. Diabetes Care. 2017 Jan;40(Suppl 1):S48-S56. Review. Erratum in: Diabetes Care. 2017 Jul;40(7):985.
Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. doi: 10.1089/dia.2014.0378. Epub 2015 Jul 14.
Bonora B, Maran A, Ciciliot S, Avogaro A, Fadini GP Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes. J Endocrinol Invest. 2016 Dec;39(12):1391-1399. Epub 2016 Jun 10.
Hoss U, Budiman ES, Liu H, Christiansen MP Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. Epub 2014 Jan 1.
New JP, Ajjan R, Pfeiffer AF, Freckmann G Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS). Diabet Med. 2015 May;32(5):609-17. doi: 10.1111/dme.12713. Epub 2015 Feb 20.
Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
