A look into the future: improving diabetes care by 2015

Abstract

Insulin initiation, which was traditionally the province of specialists, is increasingly undertaken by primary care. However, significant barriers to appropriate and timely initiation still exist. Whilst insulin is recognized as providing the most effective treatment in type 2 diabetes, it is also widely considered to be the most challenging and time consuming. This editorial identifies that the organization of existing healthcare services, the challenges faced by patients, and the treatments themselves contribute to suboptimal insulin management. In order to improve future diabetes care, it will be necessary to address all three problem areas: (1) re-think the best use of existing human and financial resources to promote and support patient self-management and adherence to treatment; (2) empower patients to participate more actively in treatment decision making; and (3) improve acceptance, persistence and adherence to therapy by continuing to refine insulin therapy and treatment regimens in terms of safety, simplicity and convenience. The principles discussed are also applicable to the successful management of any chronic medical illness.

Key words::

• Healthcare
• Insulin
• Non-adherence
• Oral antidiabetic drug
• Self-management
• Therapy adherence
• Type 2 diabetes mellitus

Introduction

Primary care practitioners are increasingly being called upon to manage chronic medical illnesses such as type 2 diabetes. It is a progressive disease requiring periodic treatment intensification from lifestyle modifications and oral anti-diabetes agents, to insulin therapy. Insulin initiation was traditionally undertaken by specialists, but owing to the growing number of patients, access to specialist care is becoming more limited to patients with complications and/or particularly poor glycemic control1–3. In contrast, the role of primary care practitioners in managing insulin has increased1,4.

Despite improvements in lipid and blood pressure control in recent years, achieving good glycemic control remains challenging5–7. Significant barriers to appropriate and timely insulin initiation still exist8–10, and the prospect of intensifying to more complex insulin regimens and the need for more frequent blood glucose monitoring may be daunting for both patients and health care professionals alike. Patients’ ability to adhere to therapy is known to be a significant problem in the treatment of chronic illnesses, and particularly in conditions such as diabetes, where patients may be asymptomatic for many years, and only develop significant morbidity in the longer term.

In many countries there is political interest in continuing to move the care of type 2 diabetes into primary care and, in so doing, reduce healthcare management costs. Insulin is recognized as providing the most effective treatment for many people with type 2 diabetes, but is also widely considered to be the most challenging and time consuming1,11. This editorial outlines the areas of diabetes care relevant to insulin therapy that need to be addressed in order to successfully manage the growing number of patients with this condition, and, where possible, to identify non-disease specific solutions so as to improve cost-effectiveness, implementation and sustainability in primary care (Figure 1).

Figure 1.  Strategies to improve diabetes care by 2015.

The content represents the consensus opinion of members of a multi-professional expert panel within specialist and community diabetes care which convened to identify, discuss and suggest potential solutions to problems with insulin management in people with diabetes.

Current status of type 2 diabetes

Type 2 diabetes is predicted to reach epidemic proportions, with a global increase in prevalence of 65% over the next 20 years12–14. It is already the sixth most commonly registered outpatient diagnosis, and the fourth most commonly diagnosed chronic condition (10%), after hypertension (24%), arthritis (13%) and dyslipidemia (12%)15. Using HbA_1c criteria, the prevalence of diagnosed and undiagnosed adult diabetes in the USA is estimated to be 9.6%, and at any one time an additional 3.5% of the population is at high risk of developing diabetes16. In people aged ≥65 years of age, the proportion with diagnosed or undiagnosed diabetes is estimated at 27%17, and in this older age group, the frequency of consultations related to diabetes rose by 45% in the period 1998–200818.

In addition, a large proportion of patients are still not reaching recommended glycemic targets. In the UK, there was a 0.1% relative improvement in HbA1c in patients with type 1 or type 2 diabetes treated with insulin between 2001 and 20075. This compared to reductions in total cholesterol and blood pressure of 15% and 29%, respectively. In Canada and the US, the proportion of patients not achieving HbA_1c<7% is estimated to be between 43 and 49%19–21; and up to two thirds of patients managed in primary care have HbA_1c>7.0%6,22.

Macrovascular complications such as myocardial infarction and stroke remain the leading causes of death in patients with diabetes23. Diabetes also remains the most common cause of end stage renal disease, and the number of patients requiring dialysis continues to grow24. Good long term glycemic control, particularly in the early years of the disease, is essential to reduce the risk of microvascular and macrovascular complications. Treatment intensification, however, commonly occurs when patients reach HbA_1c levels far in excess of recommended treatment targets25. This means that patients may wait many years before receiving appropriate insulin therapy, and that most patients with type 2 diabetes may spend the majority of the duration of their disease with suboptimal glycemic control26–28. Conversely, timely transition to insulin and a more rapid intensification of treatment may delay the onset of diabetes complications29.

Problems in diabetes care

Clinical inertia, defined as ‘recognition of the problem, but failure to act’ is a principal cause of poor glycemic control30–32. There are many reasons for this which can relate to the provision of healthcare services, the challenges faced by patients and/or the treatments used.

Healthcare services

In clinical trials of basal insulin treatment, there is a close correlation between increasing patient contact with healthcare services and the extent to which HbA1c is reduced33. Greaves et al.11 identified that, in order to support insulin conversion, health care professionals wanted more education and support including: hands-on experience, clear protocols for implementing insulin conversion, and availability of local help and support services (e.g. helplines). Access to existing educational programs is often limited by local resource issues. Inconsistent training means that vital skills, such as injection technique and self-monitoring, often remain poor34.

There is a clear role for guidelines in laying out principles of diabetes care and issuing pragmatic therapeutic strategies for health care providers. There remains a lack of consensus, however, between the international and national guidelines regarding glycemic targets (ranging between <6.5%35 to <7.5%36) and recommendations for optimal diabetes management36–39. For example, although all of the guidelines acknowledge reduced risk of hypoglycemia and improved convenience from the use of basal insulin analogues compared with human insulin preparations40, recommendations for use in clinical practice range from complete avoidance of human insulin to use of human insulin in the first instance35,36. The absence of international consensus on clinical guidance may account for a proportion of the national variations in treatment41,42.

Patient challenges

Patient knowledge is necessary to implement effective self-management and is increasingly recognized as a crucial element to achieving targets in diabetes and other chronic medical illness43. Aspects of self-management include attention to nutrition, exercise, medication, self-monitoring, problem solving, risk reduction and psychosocial adjustment44. In addition, misconceptions about the disease and treatment progression result in insulin treatment being seen as a personal failure, rather than as a necessary and expected therapy due to the progressive nature of the disease12.

Adherence to therapy is also crucial to achieving good control and avoidance of life-threatening complications45,46. The extent of medication non-adherence to oral anti-diabetes agents is reported to be between 7% and 64%47. The same appears to be true of insulin therapy, where average adherence is approximately 70%46. Side effects such as hypoglycemia and weight gain will influence therapy adherence48. In a study of oral anti-diabetes therapy, there was a 28% increase in medication non-adherence for each treatment tolerability issue such as signs/symptoms of hypoglycemia and weight gain49. The complexity of treatment regimens may also exacerbate adherence issues. Adherence to oral agents decreased from 79% with a single agent to 38% with three agents50. Peyrot et al.48 reported that almost 60% of patients miss injections, and that 20% do so on a regular basis, with worse overall adherence associated with the restrictiveness of the insulin regimen.

Insulin regimens, in particular, require patients to dose at specific times of the day, in relation to food, exercise, and the previous dose51. Whilst basal insulin administration is perhaps the least restrictive, some regimens are not easily adapted to changes in routine. Inflexible dosing is often cited as a reason for missing doses48. A recently conducted survey identified that at least one third of patients had missed an average of three doses of insulin in the previous month52. The majority of physicians thought that the number of missed doses per month was closer to six. Patients reported that the main reasons for missing doses were changes in the normal daily routine (40%), being too busy (37%), difficulty with taking the insulin at the prescribed time (31%) or simply forgetting (18%).

Treatment inadequacy and complexity

Despite the fact that insulin remains the most efficacious glucose-lowering therapy, and is perceived by health care professionals to provide considerable patient benefits11, the delay in initiation is usually longer than at any other stage of diabetes treatment intensification25. Indeed, insulin treatment complexity and the demand that this places on the existing healthcare infrastructure means that insulin is often used as a last resort. In addition, insulin injection and titration are cumbersome and time intensive for both the patient and physician. Patient self-titration has been shown to be at least as effective and safe as physician-directed titration in controlled trials53–55, and is likely to be more cost-effective in clinical practice. However, this requires patients to be skilled in performing blood glucose monitoring, dose calculation and insulin injection. Ultimately, whichever titration algorithms are selected, the need for continuous active monitoring and dose adjustment is one of the major drawbacks of current insulin therapy. Treatment success with currently available insulin therapies may also be limited by patient dissatisfaction with the need for frequent, expensive and painful blood glucose monitoring56.

At present, the majority of patients do not feel empowered to manage their diabetes. In a recent survey exploring attitudes to insulin therapy, two thirds of patients thought that their diabetes controlled their lives and that treatment regimens were too restrictive, whilst 34% felt their diabetes was not controlled in terms of blood glucose, hypoglycemia or lifestyle52. Hypoglycemia remains a significant barrier to achieving good glycemic control, particularly in patients with a longer duration of diabetes, and in elderly patients where hypoglycemia can result in significant co-morbidity57–59. Polonsky et al.9 also reported consistently negative patient beliefs regarding insulin therapy, the most frequent including therapy restrictiveness, and problematic hypoglycemia.

Optimizing future diabetes care

In order to improve future diabetes care, it will be necessary to address all three problem areas, namely the healthcare service (by improving primary care infrastructure), patient challenges (through enhancing self-management), and treatment inadequacy (by improving medication adherence and improving drug tolerability).

Improving primary care infrastructure

The existing primary care structure is overstretched and under-resourced and, as a consequence, commonly fails to optimally provide for patients with chronic medical illness. Chronic care models, whereby prepared and proactive health care teams engage regularly with informed and activated patients, have been successfully implemented in settings with minimal resources44.

At a local level, changes to infrastructure should be aimed at allowing more opportunity for patients to interact with healthcare services. This can be accomplished by decentralizing some aspects of care (for example the promotion and support of patient self-management and adherence to therapy) away from physicians to involve allied health care providers, lay staff, volunteers and family members. Promoting adherence to treatment need not necessarily be limited to prescribers, and trained non-physician personnel could be effective and more easily accessible60. At a regional level, benchmarking and sharing of best practices have been shown to improve treatment outcomes61,62 and help practices determine the best use of limited resources. At national and international levels, professional organizations and payers need to work together to reach a consensus on the goals of treatment, and close the current gap between guidelines and clinical practice63. Guidelines should consider not only the efficacy and safety of individual treatments, but also patient willingness to initiate and persist in the treatment and their ability to adhere to therapy.

Providing patient self-management support

Patients with chronic medical illnesses such as diabetes have an inevitable conflict between their desire to lead a normal life and their efforts to preserve health64. Enhancing patient self-management by involving patients in treatment decisions improves glycemic control, treatment adherence and quality of life65–67. Engaging patients in developing their own management plans also assists the health care provider in understanding where the disease and the treatment fit in the wider context of the patient’s life. In this collaborative environment, communication skills and the ability to foster behavioral change are of paramount importance64,68–70.

Patients must also be sufficiently knowledgeable to be able to engage in treatment decision making. Information may be provided verbally during a consultation, and/or in the form of reading materials, web-based applications or structured educational programs. Although the latter are often considered the gold standard approach, these are also the most resource intensive. In recent years, there has been a focus on developing web-based self-management applications which may ultimately become much more widely accessible. One example of a web-based solution is in the treatment of depression in diabetes71. Although attrition rates are quite high in this study, recruitment and follow-up by medical staff may increase adherence to such programs. The treatment of depression in association with chronic medical illness is also an example where less disease specific tools may simplify primary care management and increase cost-effectiveness through economies of scale. Care should also be taken not to overload patients with information, however, as this has been shown to negatively affect decision making64.

Improving medication adherence

The assessment of patient medication adherence by primary care physicians is an important prognostic marker for mortality in patients with type 2 diabetes72. Patient understanding of treatments improves therapy adherence73, and even practical procedural information related to a planned health care visit has been shown to reduce rates of clinic non-attendance74. Nevertheless, training on how to maximize patient adherence to treatment, as well as identifying and managing the problem is needed. Only a small minority of health care providers have training in counseling patients with non-adherence75, and so whilst poor treatment adherence is recognized as a key contributor to poor outcomes, most health professionals feel unable to address this important barrier in daily practice10. A recently published study of strategies employed by physicians to identify and treat non-adherence, suggested that educational approaches were preferred over behavioral approaches and counseling despite the fact that education alone is known to be insufficient in establishing or maintaining good adherence75.

If adherence is to improve, then more has to be done to understand patient priorities, and how to make treatments more acceptable76. Historically, the approach to improving patient adherence to long-term treatment has been to simplify the treatment regimen by reducing the frequency of dosing, and combining commonly prescribed agents into a single formulation47,77,78. In a systematic review of adherence to oral agents, reduced dosing frequency, monotherapy versus polytherapy, and conversion from monotherapy or polytherapy to single combination treatments were all successful in improving adherence47. Other successful strategies include provision of more detailed patient information, counseling, reminders and close follow-up, all of which involve more frequent healthcare interaction and consume precious resources78. Employing some of these strategies to insulin therapy in addition to addressing other patient and physician treatment ideals (e.g. reduced risk of treatment side effects, easier and more convenient dosing, and reduced requirement for blood glucose monitoring), may be one of the more effective ways to reduce barriers to insulin therapy and increase long-term insulin adherence79,80.

Improving insulin use in primary care

Insulin is a vital tool in the treatment of diabetes and more must be done to identify and address the issues that prevent insulin being used in an optimal way. This review has identified three areas that need to be addressed in order to optimize the use of insulin: (1) primary care infrastructure, (2) encouraging patients to take ownership in managing their disease, and (3) improving treatment adherence.

Additional financial investment in primary care with the specific aim of improving support for patients with chronic medical illness is important. National primary care organizations should continue to lobby for this investment. Addressing fundamental shortages in the number of specialist and allied health care personnel is a mid to long-term strategy, however, and is unlikely to have significant impact on diabetes care by 2015. In the immediate short-term, individual practices need to review their use of existing human and logistical resources (including affiliations to specialist and community networks) so as to enhance the frequency and quality of patient–provider interactions. Optimizing the clarity of communication and processes that encourage patient self-management need not be resource intensive, but do require different competencies81, and these need to be reflected in clinical guidelines. There should also be a focus on applying evidenced based recommendations where possible, which includes not just recommendations concerning therapy selection, but also skills such as injection technique34.

Lastly, by continuing to develop new insulin treatments that have attributes desired by patients and physicians this may help to break down the barriers to insulin initiation and intensification, as well as improve patient adherence. Reducing the risks of hypoglycemia, weight gain, and the complexity of treatment would be expected to facilitate initiation and adherence to insulin therapy. The broader implications of drug safety and convenience, both with respect to individual treatments and treatment strategies, needs to be more carefully considered in future consensus guidelines.

Conclusions

Whilst the authors of this paper have focused on the treatment of diabetes, the principles of re-evaluating primary healthcare infrastructure, supporting patient self-management and improving therapy adherence applies to the successful management of any chronic medical illness. In this way, infrastructural changes, self-management training for patients and multidisciplinary teams, and the development of patient support networks can also potentially benefit from economy of scale (for example, by making self-management resources, training and support less disease specific). There is clearly a need to review the way in which diabetes is managed, and to identify which infrastructural changes and additional resources are required to achieve long-term improvements in quality of life, and reductions in mortality and healthcare costs. Improvements in therapy in terms of safety, simplicity and convenience may also play a key role in improving acceptance, persistence and adherence to therapy.

Transparency

Declaration of funding

This paper represents the consensus opinion of a multidisciplinary team of experts in diabetes care who met in November 2010 to identify, discuss and put forward solutions to problems with insulin management in patients with diabetes. The meeting and medical writing assistance was organized and funded by Novo Nordisk.

Declaration of financial/other relationships

The authors disclose the following consulting income, honoraria, and/or grant support: C.T. – Novo Nordisk; W.J. – Novo Nordisk; A.H.B. – Eli Lilly, Novo Nordisk and Sanofi Aventis; S.B. – Novo Nordisk; S.G. – Novo Nordisk; D.H. – BD, BMS/AZ, Eli Lilly, Lifescan, MSD, Novo Nordisk, Roche, Sanofi-Aventis, and Takeda; E.M. – Amylin, BMS/AZ, Eli Lilly, and Novo Nordisk; M.P. – Amylin, Animas, CPEX, Eli Lilly, Genentech, Healthy Interactions, MannKind, Medtronic, Novo Nordisk and Patton Medical Devices; D.S. – Novo Nordisk; P.M.S.-D. – Berlin Chemie, Eli Lilly, Novo Nordisk and Sanofi Aventis.

Acknowledgements

This Diabetes Consensus Group comprised Stephen Brunton, Etie Moghissi, Debbie Hicks, Christine Tobin, Stephen Gough, Weng Jianping, Doron Schneider, Petra Maria Schumm-Draeger, Mark Peyrot, and Tony Barnett. All participants of the meeting have contributed directly to preparing this manuscript and/or reviewing the manuscript for scientific and historical accuracy. The authors would like to thank Christopher M. Burton from Point Of Care Medical Consulting for providing medical writing assistance.