Diabetes Mellitus, Type 2 — Patient Experiences With Injection Needles
Citation(s)
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Hirsch L, Gibney M, Berube J, Manocchio J Impact of a modified needle tip geometry on penetration force as well as acceptability, preference, and perceived pain in subjects with diabetes. J Diabetes Sci Technol. 2012 Mar 1;6(2):328-35.
Iwanaga M, Kamoi K Patient perceptions of injection pain and anxiety: a comparison of NovoFine 32-gauge tip 6mm and Micro Fine Plus 31-gauge 5mm needles. Diabetes Technol Ther. 2009 Feb;11(2):81-6. doi: 10.1089/dia.2008.0027.
Jaber A, Bozzato GB, Vedrine L, Prais WA, Berube J, Laurent PE A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol. 2008 Oct 10;8:38. doi: 10.1186/1471-2377-8-38.
Kreugel G, Keers JC, Kerstens MN, Wolffenbuttel BH Randomized trial on the influence of the length of two insulin pen needles on glycemic control and patient preference in obese patients with diabetes. Diabetes Technol Ther. 2011 Jul;13(7):737-41. doi: 10.1089/dia.2011.0010. Epub 2011 Apr 10.
Præstmark KA, Jensen CB, Stallknecht B, Madsen NB, Kildegaard J Skin blood perfusion and cellular response to insertion of insulin pen needles with different diameters. J Diabetes Sci Technol. 2014 Jul;8(4):752-9. doi: 10.1177/1932296814531099. Epub 2014 Apr 17.
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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.
