Diabetes, Gestational — Evaluation of Risk Factors for Gestational Diabetes Mellitus
Citation(s)
Bellamy L, Casas JP, Hingorani AD, Williams D Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.
DeSisto CL, Kim SY, Sharma AJ Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
Li H, Shen L, Song L, Liu B, Zheng X, Xu S, Wang Y Early age at menarche and gestational diabetes mellitus risk: Results from the Healthy Baby Cohort study. Diabetes Metab. 2017 Jun;43(3):248-252. doi: 10.1016/j.diabet.2017.01.002. Epub 2017 Feb 1.
Shen Y, Hu H, D Taylor B, Kan H, Xu X Early Menarche and Gestational Diabetes Mellitus at First Live Birth. Matern Child Health J. 2017 Mar;21(3):593-598. doi: 10.1007/s10995-016-2143-5.
Sun X, Yang L, Pan J, Yang H, Wu Y, Chen Z, Chen X, Mu L Age at menarche and the risk of gestational diabetes mellitus: a systematic review and meta-analysis. Endocrine. 2018 Aug;61(2):204-209. doi: 10.1007/s12020-018-1581-9. Epub 2018 Mar 20.
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.
