Clare Bradley and Charles J.B Gillbride (2008) Improving treatment satisfaction and other patient-reported outcomes in people with type 2 diabetes: the role of once-daily insulin glargine. Diabetes, Obesity and Metabolism, 10 (supplement 2).
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Insulin therapy becomes essential for many people with Type 2 diabetes. After starting insulin, people with diabetes that is poorly controlled with oral agents typically report improved well-being and treatment satisfaction. However, healthcare professionals and people with Type 2 diabetes are often reluctant to begin insulin treatment, citing such concerns as time/resources needed to educate patients, increased risks of hypoglycaemia and fear of injections, which lead them to focus on intensifying conventional oral therapy. Insulin glargine, which offers people with diabetes a once-a-day injection regimen with low risk of hypoglycaemia, is more likely to overcome such initial barriers than other more complex insulin regimens. Once-daily insulin glargine, in combination with modern glucose-dependent oral agents that do not need to be chased with food to prevent hypoglycaemia, does not require the fixed meal times and set amounts of carbohydrates necessary with twice-daily injection mixes and older sulphonylureas. We know it is such dietary restrictions that cause the most damage to quality of life (QoL). To avoid damaging QoL unnecessarily and to ensure optimal satisfaction with treatment it is important to evaluate the effects of treatment on QoL, treatment satisfaction and other patient-reported outcomes using questionnaires validated for this purpose, such as the widely used Diabetes Treatment Satisfaction Questionnaire and the Audit of Diabetes-Dependent Quality of Life measure. A systematic electronic literature search identified reports of studies evaluating patient-reported outcomes associated with insulin glargine in comparison with other treatments. The studies demonstrate that insulin glargine is usually associated with greater improvements in treatment satisfaction and other patient-reported outcomes compared with intensifying oral therapy or alternative insulin regimens.
This is a Published version This version's date is: 06/2008 This item is peer reviewed
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1 Stratton IM, Adler AI, Neil HA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412. 2 UKPDS. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). (UK Prospective Diabetes Study Group). Lancet 1998; 352: 837-853. 3 Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res 1999; 8: 79-91. 4 Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing quality of life. Diabetes Metab Res Rev 2002; 18 Suppl 3: S64-69. 5 Wee HL, Tan CE, Goh SY, Li SC. Usefulness of the Audit of Diabetes-Dependent Quality-of-Life (ADDQoL) questionnaire in patients with diabetes in a multi-ethnic Asian country. PharmacoEconomics 2006; 24: 673-682. 6 Nathan DM, Buse JB, Davidson MB et al. Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy : A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2006; 49: 1711-1721. 7 Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care 2005; 28: 2543-2545. 8 Rubino A, McQuay LJ, Gough SC, Kvasz M, Tennis P. Delayed initiation of subcutaneous insulin therapy after failure of oral glucose-lowering agents in patients with Type 2 diabetes: a population-based analysis in the UK. Diabet Med 2007; 24: 1412-1418. 9 Yki-Jarvinen H, Juurinen L, Alvarsson M et al. INITIATE (INITiate Insulin by Aggressive Titration and Education). A randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diabetes Care 2007. 10 Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia 2002; 45: 937-948. 11 Morris AD. Addressing dosing frequency in diabetes: a simple approach to improving adherence to therapy and clinical outcomes. Diabetes Educ 2003; 29: 440-446, 448, 450-443. 12 Polonsky WH. Emotional and quality-of-life aspects of diabetes management. Curr Diab Rep 2002; 2: 153-159. 13 Speight J, Bradley C. The Dose Adjustment For Normal Eating (DAFNE) Trail: What makes people with Type 1 diabetes agree/decline to participate? Diabet Med 2001; 18: 129. 14 Garratt AM, Schmidt L, Fitzpatrick R. Patient-assessed health outcome measures for diabetes: a structured review. Diabet Med 2002; 19: 1-11. 15 Bradley C. The diabetes treatment satisfaction questionnaire: DTSQ. In: Bradley C, ed. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Chur, Switzerland: Harwood Academic Publishers 1994. 16 Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med 1990; 7: 445-451. 17 Anderson RT, Skovlund SE, Marrero D et al. Development and validation of the insulin treatment satisfaction questionnaire. Clin Ther 2004; 26: 565-578. 18 Grootenhuis PA, Snoek FJ, Heine RJ, Bouter LM. Development of a type 2 diabetes symptom checklist: a measure of symptom severity. Diabet Med 1994; 11: 253-261. 19 Bradley C. The Well-being Questionnaire. In: Bradley C, ed. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Chur, Switzerland: Harwood Academic Publishers 1994. 20 Bradley C, Gamsu DS. Guidelines for encouraging psychological well-being: report of a Working Group of the World Health Organization Regional Office for Europe and International Diabetes Federation European Region St Vincent Declaration Action Programme for Diabetes. Diabet Med 1994; 11: 510-516. 21 Jennings AM, Lewis KS, Murdoch S, Talbot JF, Bradley C, Ward JD. Randomized trial comparing continuous subcutaneous insulin infusion and conventional insulin therapy in type II diabetic patients poorly controlled with sulfonylureas. Diabetes Care 1991; 14: 738-744. 22 Taylor R, Foster B, Kyne-Grzebalski D, Vanderpump M. Insulin regimens for the non-insulin dependent: impact on diurnal metabolic state and quality of life. Diabet Med 1994; 11: 551-557. 23 Wilson M, Moore MP, Lunt H. Treatment satisfaction after commencement of insulin in Type 2 diabetes. Diabetes Res Clin Pract 2004; 66: 263-267. 24 Howorka K, Pumprla J, Schlusche C, Wagner-Nosiska D, Schabmann A, Bradley C. Dealing with ceiling baseline treatment satisfaction level in patients with diabetes under flexible, functional insulin treatment: assessment of improvements in treatment satisfaction with a new insulin analogue. Qual Life Res 2000; 9: 915-930. 25 Bradley C. Diabetes treatment satisfaction questionnaire. Change version for use alongside status version provides appropriate solution where ceiling effects occur. Diabetes Care 1999; 22: 530-532. 26 Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes 2007; 5: 57. 27 Gerstein HC, Yale JF, Harris SB, Issa M, Stewart JA, Dempsey E. A randomized trial of adding insulin glargine vs. avoidance of insulin in people with Type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with Insulin Glargine for Hyperglycaemia Treatment) Study. Diabet Med 2006; 23: 736-742. 28 Houlden R, Ross S, Harris S, Yale JF, Sauriol L, Gerstein HC. Treatment satisfaction and quality of life using an early insulinization strategy with insulin glargine compared to an adjusted oral therapy in the management of Type 2 diabetes: the Canadian INSIGHT Study. Diabetes Res Clin Pract 2007; 78: 254-258. 29 Mitchell J, Wolffsohn JS, Woodcock A et al. +Psychometric evaluation of the MacDQoL individualised measure of the impact of macular degeneration on quality of life. Health Qual Life Outcomes 2005; 3: 25. 30 Woodcock A, Bradley C, Plowright R, ffytche T, Kennedy-Martin T, Hirsch A. The influence of diabetic retinopathy on quality of life: interviews to guide the design of a condition-specific, individualised questionnaire: the RetDQoL. Patient Educ Couns 2004; 53: 365-383. 31 Shen W, Kotsanos JG, Huster WJ, Mathias SD, Andrejasich CM, Patrick DL. Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire. Medical care 1999; 37: AS45-66. 32 Hayes R, Bowman L. Reliability and validity of the Treatment Flexibility Scale. Qual Life Res 2003; 12: 863. 33 Riazi A, Ishii H, Barendse S, Bradley C. Well-being questionnaire (W-BQ): translation and psychometric development of a short form (W-BQ12) in Japanese. Proc Brit Psychol Soc 1999; 7 (Suppl 1) 34A. 34 Riazi A, Bradley C, Barendse S, Ishii H. Development of the Well-being questionnaire short-form in Japanese: the W-BQ12. Health Qual Life Outcomes 2006; 4: 40. 35 Witthaus E, Stewart J, Bradley C. Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with Type 1 diabetes. Diabet Med 2001; 18: 619-625. 36 Pouwer F, Snoek FJ, van der Ploeg HM, Ader HJ, Heine RJ. The well-being questionnaire: evidence for a three-factor structure with 12 items (W-BQ12). Psychol Med 2000; 30: 455-462. 37 Mitchell J, Bradley C. Psychometric evaluation of the 12-item Well-being Questionnaire for use with people with macular disease. Qual Life Res 2001; 10: 465-473. 38 McMillan CV, Bradley C, Gibney J, Russell-Jones DL, Sonksen PH. Psychometric properties of two measures of psychological well-being in adult growth hormone deficiency. Health Qual Life Outcomes 2006; 4: 16. 39 Weisbord SD, Fried LF, Arnold RM et al. Development of a symptom assessment instrument for chronic hemodialysis patients: the Dialysis Symptom Index. Journal of pain and symptom management 2004; 27: 226-240. 40 Vinik AI, Zhang Q. Adding Insulin Glargine Versus Rosiglitazone: Health-related quality-of-life impact in type 2 diabetes. Diabetes Care 2007; 30: 795-800. 41 Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005; 143: 559-569. 42 Secnik Boye K, Matza LS, Oglesby A et al. Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes. Health Qual Life Outcomes 2006; 4: 80. 43 Bradley C. Importance of differentiating health status from quality of life. Lancet 2001; 357: 7-8. 44 Mitchell J, Bradley C. Measuring quality of life in macular disease: what use are utilities? Proceedings of vision 2005; International congress series 2005; 1282: 654-658. 45 Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical care 1992; 30: 473-483. 46 Woodcock AJ, Julious SA, Kinmonth AL, Campbell MJ. Problems with the performance of the SF-36 among people with type 2 diabetes in general practice. Qual Life Res 2001; 10: 661-670. 47 Meneghini LF, Schwartz S, Rak ES, Harris A, Strange P. Improved glycemic control with insulin glargine (GLAR) vs pioglitazone (PIO) as add-on therapy in patients with type 2 diabetes (T2D) uncontrolled on sulfonylurea (SU) or metformin (MET) monotherapy. Diabetes 2005; 54 (Suppl 1): Abstrast 10-LB. 48 Fischer JS, McLaughlin T, Loza L, Beauchamp R, Schwartz S, Kipnes M. The impact of insulin glargine on clinical and humanistic outcomes in patients uncontrolled on other insulin and oral agents: an office-based naturalistic study. Curr Med Res Opin 2004; 20: 1703-1710. 49 Witthaus E, Stewart J, Bradley C. Improved psychological outcomes after initiation of insulin treatment in patients with Type II diabetes. Diabetologia 2000; 43 (Suppl 1): A205. 50 Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care 2006; 29: 554-559. 51 Meneghini LF, Schwartz S, Strange P, Oster G. Health-related quality of life and costs of receiving add-on therapy with insulin glargine or pioglitazone in patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl 1): 543 (Abstrast 0894). 52 Vinik AI, Zhang Q. Health-related quality of life (HRQOL) and early study termination in patients adding insulin vs a thiazolidinedione to one or two oral agents. Diabetes 2006; 55 (Suppl 1): A137 (Abstract 576-P). 53 Massi Benedetti M, Humburg E, Dressler A, Ziemen M. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res 2003; 35: 189-196. 54 Bretzel RG, Nuber, U., Wolfgang, Landgraf., Owens, David., Bradley, C., Linn, T.,. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial. Lancet 2008; 371: 1073-1084. 55 DAFNE study group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ 2002; 325: 746. 56 Raskin P, Allen E, Hollander P et al. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005; 28: 260-265. 57 Brod M, Cobden D, Lammert M, Bushnell D, Raskin P. Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues. Health Qual Life Outcomes 2007; 5: 8. 58 Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005; 28: 254-259. 59 Bradley C, El-Haschimi K. Treatment satisfaction in patients with type 2 diabetes: basal insulin plus oral agents versus twice-daily premixed insulin alone – analyses by country. Diabet Med 2006; 23 (Suppl 1): 361 (Abstract P1010). 60 Yoo BK, Triller DM, Yoo DJ. Exenatide: a new option for the treatment of type 2 diabetes. Ann Pharmacother 2006; 40: 1777-1784. 61 Currie CJ, Morgan CL, Poole CD, Sharplin P, Lammert M, McEwan P. Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes. Curr Med Res Opin 2006; 22: 1523-1534. 62 Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care 1987; 10: 617-621. 63 Irvine A, Cox D, Gonder-Frederick L. The Fear of Hypoglycaemia Scale. In: Bradley C, ed. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Chur, Switzerland: Harwood Academic Publishers 1994. 64 de Luis DA, Aller R, Cuellar L et al. Effect on quality of life with a new insulin injection device in elderly patients with diabetes mellitus type 2. J Diabetes Complications 2004; 18: 216-219. 65 Korytkowski M, Bell D, Jacobsen C, Suwannasari R. A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clin Ther 2003; 25: 2836-2848. 66 Rubin RR, Peyrot M. Quality of life, treatment satisfaction, and treatment preference associated with use of a pen device delivering a premixed 70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart) versus alternative treatment strategies. Diabetes Care 2004; 27: 2495-2497. 67 Stockl K, Ory C, Vanderplas A et al. An evaluation of patient preference for an alternative insulin delivery system compared to standard vial and syringe. Curr Med Res Opin 2007; 23: 133-146. 68 Summers KH, Szeinbach SL, Lenox SM. Preference for insulin delivery systems among current insulin users and nonusers. Clin Ther 2004; 26: 1498-1505. 69 Jacobsen AM, DCCT Research Group. The Diabetes Quality of Life Measure. In: Bradley C, ed. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Chur, Switzerland: Harwood Academic Publishers 1994. 70 Davis TM, Clifford RM, Davis WA. Effect of insulin therapy on quality of life in Type 2 diabetes mellitus: The Fremantle Diabetes Study. Diabetes Res Clin Pract 2001; 52: 63-71. 71 UKPDS. Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). U.K. Prospective Diabetes Study Group. Diabetes Care 1999; 22: 1125-1136.