Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
Cramer JA, Pugh MJ The influence of insulin use on glycemic control: How well do adults follow prescriptions for insulin? Diabetes Care. 2005 Jan;28(1):78-83. Erratum in: Diabetes Care. 2005 Mar;28(3):767.
Cuddihy RM, Philis-Tsimikas A, Nazeri A Type 2 diabetes care and insulin intensification: is a more multidisciplinary approach needed? Results from the MODIFY survey. Diabetes Educ. 2011 Jan-Feb;37(1):111-23. doi: 10.1177/0145721710388426. Epub 2010 Dec 3.
Davies M, Lavalle-González F, Storms F, Gomis R; AT LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
Hayes RP, Fitzgerald JT, Jacober SJ Primary care physician beliefs about insulin initiation in patients with type 2 diabetes. Int J Clin Pract. 2008 Jun;62(6):860-8. doi: 10.1111/j.1742-1241.2008.01742.x. Epub 2008 Apr 3.
Hou C, Carter B, Hewitt J, Francisa T, Mayor S Do Mobile Phone Applications Improve Glycemic Control (HbA1c) in the Self-management of Diabetes? A Systematic Review, Meta-analysis, and GRADE of 14 Randomized Trials. Diabetes Care. 2016 Nov;39(11):2089-2095. Review.
Meneghini L, Koenen C, Weng W, Selam JL The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13.
Nichols GA, Koo YH, Shah SN Delay of insulin addition to oral combination therapy despite inadequate glycemic control: delay of insulin therapy. J Gen Intern Med. 2007 Apr;22(4):453-8.
Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.
Ratanawongsa N, Crosson JC, Schillinger D, Karter AJ, Saha CK, Marrero DG Getting under the skin of clinical inertia in insulin initiation: the Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project. Diabetes Educ. 2012 Jan-Feb;38(1):94-100. doi: 10.1177/0145721711432649. Epub 2012 Jan 5.
Sorli C, Heile MK Identifying and meeting the challenges of insulin therapy in type 2 diabetes. J Multidiscip Healthc. 2014 Jul 2;7:267-82. doi: 10.2147/JMDH.S64084. eCollection 2014. Review.
Strain WD, Blüher M, Paldánius P Clinical inertia in individualising care for diabetes: is there time to do more in type 2 diabetes? Diabetes Ther. 2014 Dec;5(2):347-54. doi: 10.1007/s13300-014-0077-8. Epub 2014 Aug 12.
Walker RJ, Smalls BL, Hernandez-Tejada MA, Campbell JA, Egede LE Effect of diabetes self-efficacy on glycemic control, medication adherence, self-care behaviors, and quality of life in a predominantly low-income, minority population. Ethn Dis. 2014 Summer;24(3):349-55.
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.
