Herrero P, Pesl P, Bondia J, Reddy M, Oliver N, Georgiou P, Toumazou C Method for automatic adjustment of an insulin bolus calculator: in silico robustness evaluation under intra-day variability. Comput Methods Programs Biomed. 2015 Apr;119(1):1-8. doi: 10.1016/j.cmpb.2015.02.003. Epub 2015 Feb 16.
Kovatchev BP, Breton M, Man CD, Cobelli C In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J Diabetes Sci Technol. 2009 Jan;3(1):44-55.
Lepore G, Dodesini AR, Nosari I, Scaranna C, Corsi A, Trevisan R Bolus calculator improves long-term metabolic control and reduces glucose variability in pump-treated patients with Type 1 diabetes. Nutr Metab Cardiovasc Dis. 2012 Aug;22(8):e15-6. doi: 10.1016/j.numecd.2012.04.001. Epub 2012 Jun 4.
National Clinical Guideline Centre (UK) Type 1 Diabetes in Adults: Diagnosis and Management. London: National Institute for Health and Care Excellence (UK); 2015 Aug.
Reddy M, Pesl P, Xenou M, Toumazou C, Johnston D, Georgiou P, Herrero P, Oliver N Clinical Safety and Feasibility of the Advanced Bolus Calculator for Type 1 Diabetes Based on Case-Based Reasoning: A 6-Week Nonrandomized Single-Arm Pilot Study. Diabetes Technol Ther. 2016 Aug;18(8):487-93. doi: 10.1089/dia.2015.0413. Epub 2016 May 19.
Sovik O, Thordarson H Dead-in-bed syndrome in young diabetic patients. Diabetes Care. 1999 Mar;22 Suppl 2:B40-2. Erratum in: Diabetes Care 1999 Aug;22(8):1389.
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.
