Diabetes Mellitus — Reliability of Insulin by Jet Injection
Citation(s)
Engwerda EE, Abbink EJ, Tack CJ, de Galan BE Improved pharmacokinetic and pharmacodynamic profile of rapid-acting insulin using needle-free jet injection technology. Diabetes Care. 2011 Aug;34(8):1804-8. doi: 10.2337/dc11-0182. Epub 2011 Jun 29.
Gill GV, Yudkin JS, Keen H, Beran D The insulin dilemma in resource-limited countries. A way forward? Diabetologia. 2011 Jan;54(1):19-24. doi: 10.1007/s00125-010-1897-3. Epub 2010 Sep 12.
Julious SA Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. Review.
Kerum G, Profozic V, Granic M, Skrabalo Z Blood glucose and free insulin levels after the administration of insulin by conventional syringe or jet injector in insulin treated type 2 diabetics. Horm Metab Res. 1987 Sep;19(9):422-5.
Malone JI, Lowitt S, Grove NP, Shah SC Comparison of insulin levels after injection by jet stream and disposable insulin syringe. Diabetes Care. 1986 Nov-Dec;9(6):637-40.
Mitragotri S Current status and future prospects of needle-free liquid jet injectors. Nat Rev Drug Discov. 2006 Jul;5(7):543-8.
Pehling GB, Gerich JE Comparison of plasma insulin profiles after subcutaneous administration of insulin by jet spray and conventional needle injection in patients with insulin-dependent diabetes mellitus. Mayo Clin Proc. 1984 Nov;59(11):751-4.
Taylor R, Home PD, Alberti KG Plasma free insulin profiles after administration of insulin by jet and conventional syringe injection. Diabetes Care. 1981 May-Jun;4(3):377-9.
Weller C, Linder M Jet injection of insulin vs the syringe-and-needle method. JAMA. 1966 Mar 7;195(10):844-7.
Reproducibility of Insulin Action When Administered by Needle-free Jet Injection
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.
