Keywords

Introduction: The Ongoing Story of Diabetes Clinics

In the 1960s, diabetes was considered a common disease, even when being much less common than today; the average practitioner treated 15 or 16 known patients, and hospital clinics admitted approximately 1000 patients each year [1, 2]. The first diabetes clinics were established in North America and Europe in the years following the discovery of insulin with the main objective of teaching patients the technique and principles of its use; only in Britain, 500 had been established in 1973, even in isolated geographical entities [1, 3]. Hospital surveys showed that diabetes was controlled by diet and insulin, early diabetic complications and patient education were overlooked by physicians, and diabetic management by nursing, administrative, and dietetic staff was considered ineffective [4]. Successful clinics prevailing until today were the ones that had the vision, ability, and resources to institute comprehensive diabetic services which coordinated the activities of medical, nursing, and dietetic staffs to deliver multidisciplinary outpatient care, “special services” (dietetic, foot, eye, pregnancy, children, and adolescents), and diabetes education programs as essential components of their services [4,5,6,7]. These programs showed marked improvements in all areas of diabetes care, including diagnosis, assessment, hypoglycemia prevention, diet, and referrals [4]. In the majority of hospitals, patients with diabetes admitted to hospitals were seen mostly by specialists, but the sharp rise in the prevalence of type 2 diabetes made this unpractical [8]. Hospital diabetes programs including telephone support for patients, screening by nurses, and a mixture of outpatient and inpatient services showed reductions in emergency room visits, decreases in the incidence of acute complications (ketoacidosis, hypoglycemia) and amputations, lower rates of broken appointments and complaints, and higher levels of patient and professional satisfaction [9, 10]. Most of the other hospitals told a different story: once referred, patients were supposed to be treated for life, doomed to take time out of work and travel, and wait to be seen by a different physician at almost every visit at the diabetes clinic; this approach of fleeting consultations was – and still is – unrewarding from every perspective [1]. Even when the estimated incidence of diabetes was 1.2–1.3% in England, diabetic clinics had such a large load that they became unable to devote sufficient time to difficult cases; medical manpower to deal with the growing workload was (and currently more than ever) met with increasing use of junior staff, resulting in large dropout rates, lack of adherence, high levels of patient dissatisfaction, and abysmal levels of quality of care [1, 2]. Taking into account that the average diabetic required seven to ten clinical visits every year, hospital demands meant establishing huge diabetic clinics with dissatisfaction and depersonalization for patients and staff [1]. In Germany and other countries, hospital diabetes management was paternalistic; patients were admitted to stabilize blood glucose control, and the lack of self-care support had many consequences: glycosuria was preferred to prevent hypoglycemia, the routine therapy was one or two injections of medium-acting insulin per day, self-monitoring and changes in insulin dosage were not allowed, and education was conceived as “obedience training” to follow rigid dietary prescriptions consisting of six to seven meals with fixed amounts of carbohydrates, proteins and fats, and prohibition of sugar [11]. This approach was never assessed, but acute and late complications were evident and frequent [11]. Hospital wards overflowed with patients with diabetes routinely assigned to hospital beds in hallways, timely access to appropriate medical advice was poor, hospital resources were largely devoted to episodic care for acutely and severely ill patients, there was low supervision by specialists, and rates of acute complications were very high [8, 9]. Inpatient hospital care represented >80% of the direct costs of diabetes and was related to higher risks of cardiovascular complications and renal disease [12]. On the other hand, understaffing and low resources to outpatient facilities were associated with an excess in hospital admissions and direct costs [13]. With the increasing rates of diabetes in recent decades, the amount of patients admitted to hospitals continues to rise [14]. They are more likely to die in the hospital, to occupy more bed days, and to incur in higher costs than people without diabetes [14]. Health systems, unable or unwilling to reinforce multidisciplinary outpatient management, can only expect to see increases in the financial and health burden of preventable hospitalizations [15]. The title of an article by Simmons and Wenzel is accurate: in many cases, diabetes inpatients are a case of lose, lose, lose [14]. The aim of diabetes care should be enabling patients to lead normal lives, with good metabolic control and free from complications. For many patients across the world, such an ideal is still far away [13].

Lessons Learned and Still Unlearned

Failure of clinics established at hospitals, which rapidly became overwhelmed, increased the role of primary healthcare professionals in the shared care of diabetes management. General physicians became increasingly aware of the importance of tailoring management to patient’s lifestyles, their expectation to be actively involved in their treatment, and their unwillingness to continue accepting medical advice without questioning [8]. General practitioners in the United Kingdom were among the first to see that they could manage many aspects of diabetes in their own practice. Albeit the pace to provide ambulatory diabetes care was initially slow, many innovative schemes were described and initiated [16]. Combination of need and opportunity prompted the creation of “small clinics of general practice” where groups of general physicians were organized to assist groups of 80 to 100 patients to stop the flow of patient to hospital-based clinics devoted to difficult cases [2, 18, 19]. Pioneering reports from Wilkes, Thorn, Russell, Hill, Singh, and colleagues showed that:

  1. 1.

    Diabetes could be looked after by the family doctor [1].

  2. 2.

    General practice seemed the proper place to look after many diabetics, allowing general practitioners to become increasingly competent in diabetes care [2].

  3. 3.

    Coordinating and sharing “the diabetic workload” with hospital clinics raised community awareness about diabetes, allowing family physicians to deal with problems for which they were trained [17].

  4. 4.

    “Diabetes care delivered by organized general physicians achieved similar levels of metabolic control to the ones reached in hospital clinics” [18].

To summarize, increases in the number of patients with type 2 diabetes, longer life expectancy, and sophistication of treatment produced overcrowding and inadequacies of delivery in hospital-based diabetes care [20, 21]. Increasingly low rates of access to hospital or university clinics and unsuccessful indices of performance occurred, even in countries with large and comparatively smaller populations of patients [20, 21]. Home and Walford reflected that “though some activities required the expertise and resources only available in hospitals, most of them did not require them, as long as general physicians had access to blood glucose monitoring, dietetic, chiropody and nurse educational services [20].” The need to reappraise the role of diabetes clinics was recognized by Thorn and Russell since 1973, but it was also essential to increase the access to effective diabetes management, because only a small proportion of patients attended hospital and outpatient clinics [20, 21]. Since 1986, it was acknowledged that the huge amount of people with diabetes in the community made it unrealistic to treat them in specialist outpatient clinics [21].

Transforming Diabetes Care

Suboptimal diabetes care was associated with high hospital admission rates and poor diagnostic differentiation between patients with mild and severe metabolic problems. Planning of diabetes services needed to be broader beyond those available in most centers, but surveys at facilities demonstrated (and continue to show) large discrepancies with recommended national and international guidelines [22]. A survey carried out by the Medical Advisory Committee (MAC) in Britain showed a scarcity of diabetes clinics or even examination rooms, resulting in lack of referrals; a variety of deficiencies in access to professional services, including obstetricians, ophthalmologists, dietitians, chiropodists, and nurses; a scarcity in the availability of resources to measure glucose and A1c; and absent or inadequate facilities to deliver diabetes education [23]. Nineteen recommendations were endorsed by the MAC; a follow-up report 10 years later showed significant improvements in all the previously described deficiencies, albeit there was still room for improvement [24]. Even when resources were insufficient, reorganization and integration of services produced great improvements in healthcare standards. From its inception in the 1970s, the concept of diabetes centers evolved to a number of “different breeds in the 1990s” [25]. Dunn and colleagues identified four priority areas to be considered for implementation of the Diabetes Control and Complications Trial (DCCT) in Australia: (1) allocation and effective use of resources, (2) standards of care and quality assurance, (3) training and continuing education, and (4) research and evaluation [25].

Effectiveness of Diabetes Outpatient Management: The Evidence

Diabetes centers evolved from traditional hospitalization of new patients; hospital admission to start insulin was occasionally used, but ambulatory care became the norm. The main objective of diabetes management became preventing or delaying the physical and social consequences of the disorder [19]. Early reports showed that transforming traditional to modern management methods was feasible, acceptable, and effective and produced significant improvements in A1c levels without associated increases in the frequency of hypoglycemia [24]. Recent emphasis on issues of cost-effectiveness came to realize that diabetes is a disorder that rarely warrants hospitalization; awareness to these facts reinforced the concept of diabetes ambulatory care [25]. Nevertheless and despite demonstrations of cost-effectiveness of ambulatory management, funding of ambulatory services remained (and continues to be) in huge disadvantage with hospital care [25]. The 1980s witnessed the emergence of multiple initiatives devoted to shift the focus of diabetes management from hospitals to outpatient clinics in Europe, North America, and Australia. Table 20.1 shows examples of outpatient diabetes programs manually collected or identified in a PubMed search from 1980 thru 2018.

Table 20.1 Experiences of outpatient diabetes management across the world
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Outpatient Management of Type 1 Diabetes

Traditional models for type 1 diabetes are organized around a specialist with a multidisciplinary team to deal with education, nutrition, and psychosocial adjustment [55]. A limited number of patients with type 1 diabetes are treated by primary physicians, but even in developed countries, availability and geographical distribution of specialists are real obstacles to refer all these patients to diabetologists [56,57,58]. Even in the United States, it was estimated that in 2014 the shortage of adult and pediatric endocrinologists was of 1500 and 100, respectively, and that the gap for adult endocrinologists would expand to 2700 [58]. Models of primary care for type 1 diabetes are scarce, but innovative strategies have been conceived and implemented. Based on experiences collected as one of the participating centers in the DCCT, in 1988 the International Diabetes Center organized a team comprising three family physicians, four endocrinologists, a clinical epidemiologist, three nurse specialists, and a dietitian and developed Staged Diabetes Management (SDM), a systematic approach to support clinical decision-making including clinical pathways or DecisionPaths to start, adjust, maintain, or change therapies [55, 59]. Initial experiences with SDM in the United States demonstrated its feasibility and its capacity to standardize clinical practice, reduce clinical inertia, and establish criteria for referral [59]. International dissemination of Staged Diabetes Management has confirmed its feasibility and effectiveness [33, 41, 45].

Challenges of Comorbidity and Multi-morbidity in Diabetes Management

Treating chronic diseases like diabetes is often complicated by the coexistence of multiple medical conditions and of social and psychological deterrents; currently, the most common chronic condition among adults is multi-morbidity [60, 61], in the words of Kate Lorig, “the Disease of the 21st Century [62].” The contribution of multi-morbidity to the global burden of disease is already huge, but projections are of great concern: it is estimated that during the last 15 years of life, one half of the newborns in industrialized countries will suffer multi-morbidity and its consequences, including poor quality of life, psychological distress, worsening functional capacity, longer hospital stays, higher costs of care, and higher mortality [63,64,65,66,67]. MM also affects processes of care resulting in complex self-care needs; multiple organizational problems; polypharmacy; increased use of emergency facilities; difficulties to apply clinical guidelines; fragmented, costly, and ineffective care; and higher mortality rates [66,67,68,69,70,71]. Multi-morbidity is important for diabetes management because besides its long-time recognized association with metabolic and cardiovascular risk factors, the frequency of nondiabetes-related (or non-apparently related) comorbidities is starting to be recognized. Negative outcomes associated with multi-morbidity partly result from the fact that healthcare delivery is organized and designed for patients with single diseases [63]. Fortin and colleagues state that “clinical practice is still based on a single disease paradigm which is not appropriate for patients with complex and overlapping health problems [66]”. To make matters worse, most clinical trials exclude patients with comorbidity, therefore limiting generalization of research results [71]. Diabetes management clearly applies to these statements: until recently, clinical guidelines failed to recognize the importance of comorbidity, and it has been demonstrated that this is a limiting factor to their implementation [63]. Research about the epidemiology of multi-morbidity, its consequences, and its effects on the process of care is still very limited [71,72,73,74,75].

Definitions and Magnitude

Multi-morbidity (MM) was originally defined by Feinstein in 1970 as “the coexistence of two or more diseases, pathological conditions or clinical entities in the same patient” [76], while comorbidity (CM) is defined as the presence of one index disease and at least one other chronic condition in the same person [77]. MM and CM have become some of the greatest challenges and an additional pressure on healthcare systems. They represent an additional burden on the acute care model which impedes in many cases, even recognizing the main complaint in a hurried visit. Increased effectiveness of healthcare interventions have delayed death by managing (not curing) diseases but have also led to a marked increase in the coexistence of separate diseases in individuals [78]. In less than three decades, the frequency of chronic diseases and associated patterns of comorbidity and multi-morbidity have escalated for several reasons: (1) lowered diagnostic thresholds, (2) new diagnoses, and (3) true increases of some diseases, such as diabetes [78, 79]. Table 20.2 confirms the steady increase in the worldwide prevalence of comorbidity (two or more diseases) in every age group, associated disease patterns, and outcomes.

Table 20.2 Epidemiology of multi-morbidity and comorbidity
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Multi-morbidity in Diabetes: The Elephant in the Medical Office

Comorbidity and multi-morbidity are extremely frequent among patients with diabetes; its association with cardiovascular risk factors has been recognized for a long time. From this perspective, Piette and Kerr proposed a framework to consider ways by which associated chronic conditions could influence diabetes medical care, self-management, and outcomes [110]. They classified comorbidities in three groups, (1) clinical dominant conditions, (2) concordant versus discordant chronic conditions, and (3) symptomatic versus asymptomatic chronic conditions, and recognized, in the first place, the preeminence of diseases like cancer, end-stage renal failure, or severe cognitive impairment in the realities of diabetes care and even on life expectancy. Comorbidities in the second group are very common and compete for time in the medical visit and for resources from patients and their families; some of them are inextricably related to the outcomes of diabetes care (hypertension, dyslipidemia), and others are related from their emotional outcomes (depression, stress) or through recently explained pathogenic mechanisms (musculoskeletal diseases). The third group includes chronic conditions which should be managed regardless of being symptoms, worsening, or recurrence [110]. Most reports about diabetes and chronic disease are about associations with single medical disorders or clusters of chronic conditions, in denial of the unifying role of diabetes in the pathogenesis of apparently disparate disorders within the cardiovascular, musculoskeletal, or digestive systems. The study of comorbidity in patients with diabetes is a recent topic and is summarized in Table 20.3.

Table 20.3 Comorbidity in patients with diabetes
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Multi-morbidity in Patients with Diabetes: How Can It Be Explained?

The results of studies described in Tables 20.2 and 20.3 confirm the increasing prevalence of co-morbidity and multi-morbidity. In people with diabetes, the prevalence more than doubles the observed rates in people without diabetes, partly explained by the long-time recognized aggregation of cardiovascular risk factors. The concept of multi-morbidity started with a uni-level approach: to the simple counting of co-occurring diseases [122]. Patients are usually managed for each individual disease according to specific guidelines and by different physicians [123]. The logical limitations of this approach have encouraged a shift to integrated, albeit limited, approaches to meet the needs of individual patients [123]. The current view and classification of human disease dates to the late nineteenth century and derive from the observational correlation between pathological analysis and clinical syndromes [124]. Over the years, attention to the interactions of multiple, apparently unrelated diseases occurring at different levels led to a vertical dimension which attempts to clarify the complex interactions of multi-morbidity at the cellular, organizational, and community (even the emotional) levels [117]. In a brilliant essay, Aron addressed the additional burden imposed by multi-morbidity on diabetes self-management and the conflicts and potential risks of glycemic control [122]. A new, holistic view suggests that common linked pathophysiological pathways underlie the development of diseases in a non-organ-specific manner and that multiple diseases within one person, regardless of symptoms or organ system, are not necessarily caused by independent mechanisms [123]. Taking into account the highly internal organization of the cell, it would be possible to improve the single gene-one disease approach by developing a conceptual framework to link all genetic disorders with the complete list of disease genes, resulting in a global view of the “diseasome,” the combined set of all known disease/gene associations [125]. In the “human disease network,” nodes represent diseases, and two diseases are connected if they share at least one gene in which mutations are associated with both diseases [125]. The existence of intricate molecular links between subcellular components and disease genes raises the possibility that diseases may not be as independent of each other as physicians traditionally consider them to be and that diseases form networks in which two of them are connected if they share at least one gene [126]. Diabetes management at one level ignores its complexity, clearly illustrated by its unique aggregation of concordant and discordant conditions…clinicians must think in multiple dimensions! [122].

Addressing Comorbidity in Clinical Practice

Several instruments have been devised to measure comorbidity [127], but the most widely used is the Charlson Comorbidity Index (CCI) [128]. Developed by Mary E. Charlson and colleagues, the CCI assigns a weight of 1 to 10 for a variety of diseases, including diabetes without organ damage [129]. Six diseases have weights of 2, one disease has a weight of 3, and two diseases have weights of 6, in order to calculate the relative risk of 1-year mortality by summing the weights of each condition [129]. Index scores range from 0 to 10, although higher scores are possible for severely ill patients [129]. The CCI has been used to estimate prognosis of comorbidities in a variety of disciplines, from dermatology to oncology, and its power to predict morbidity, mortality, costs, and hospitalizations has been validated and compared with other measures [130]. Its use continues to extend, and it has become available in several versions of online calculators.

Comorbidity is usually managed by different specialists (“as many as necessary”), using independent clinical guidelines. This approach is ineffective and conflicting, increases the demand of professional services and costs, and may even pose risks for the patients. Current disease-oriented guidelines do not account the interactions between different diseases and are designed to manage single chronic conditions [131]. Innovative approaches have been proposed to address the challenge of comorbidity, such as the Adriane principles, a tool to support decision-making during consultations in primary care that involve patients [132, 133]. The Adriane principles were designed as a process aimed to foster an innovative concept in medical decision making for patients with multimorbidity in primary care [132]. This approach establishes realistic goals at the center and three core principles: (1) individualized management, (2) prioritization of patients’ preferences, and (3) interactive assessment [132, 133]. The effectiveness of implementing the Adriane principles in comorbidity management remains to be demonstrated.

Challenges of Multi-morbidity in Diabetes Management

Multiple diseases have an additive effect: comorbidity or multi-morbidity has negative effects on mental status and quality of life and increases the frequency of medical visits and the risk of death [67, 134]. Models of integrated, simplified care of comorbidities involving chronic physical disease and mental disorders can decrease disabilities and are associated with significant reductions in total healthcare costs and hospital costs [68, 135]. The challenge to deliver patient-centered care for people with comorbidities is to provide the right care for the right person at the right time, but current medical structures do not support multidimensional care and encourage treating only disease-specific outcomes [136]. The number and type of comorbid diseases have multiple consequences in patients with diabetes, create competing demands, and promote clinical inertia [137, 138], negatively influencing glycemic and cardiovascular risk control [139, 140]. Comorbidity should be screened at baseline and follow-up visits. The evidence about effective interventions in the management of patients with multi-morbidity is still limited, and remaining uncertainties prevail, despite its high prevalence and impact on patients and healthcare systems [141, 142]. The last two decades have witnessed a steady increase of knowledge about comorbidity in medicine, which has become a challenge for researchers, clinicians, and health policy makers. The current narrow focus on single diseases should be replaced with a holistic view and approach to established patterns of comorbidity and multi-morbidity [143, 144]. Only a radical rethinking of health systems will facilitate the transition and challenges multi-morbidity and its associated disability [145].

The Chronic Care Model and Diabetes

Usual medical care often fails to meet the needs of patients with chronic diseases, even in advanced countries [146]. Meeting the complex needs of patients with chronic illness or disability is the single greatest challenge facing organized medical practice, and usual care is not doing the job [147]. Most of the patients with diabetes either have no access to medical care or receive inadequate treatment [148]. To improve care for patients with chronic diseases, the negative evidence continuing to accumulate about the inefficacy of usual care and the positive evidence about the benefits of innovations in ambulatory care have encouraged new paradigms. Based on their work at Group Health Cooperative of Puget Sound, Washington, literature reviews, and suggestions of an advisory panel, two decades ago, Wagner and colleagues developed a model to improve chronic illness care, a guide to be used to develop effective chronic care by incorporating successful interventions [147]. The chronic care model (CCM) is based on the reality that in chronic diseases, the outcomes are largely dependent on the efforts, resources, and support of patients and their families [149]. The success of treatment requires that patients are well informed about their disease, the place where they can receive treatment, and to have greater control over their treatment [150]. The CCM is not a quick and easy fix or an abstract theory; it is a multidimensional solution to a complex problem, a concrete guide to improve clinical practice [148]. Care for chronic noncommunicable diseases (NCDs) is a global problem; the CCM is a tool to deliver integrated management for NCDs within the context of primary care and provides practical guidance for healthcare program managers, policy makers, and stakeholders to plan and deliver high-quality services for people with NCDs [151].

Taking into account that chronic illness care is largely performed within the primary care setting, the CCM has become a major component [147, 152]. The CCM assumes that medical care is centered in the interaction of patients and practice teams, with support for self-management from the community and organization of healthcare inside and outside the health system [153]. By comparison to usual care, in which isolated physicians give orders to patients, chronic disease management involves collaboration from a group of clinicians from diverse disciplines (nurse case managers, physicians, pharmacists, social workers, dietitians, lay health workers) who communicate regularly and participate in the care of a defined group of patients. Chronic care occurs in three overlapping scenarios: (1) the community, (2) the health system, and (3) the healthcare organization, taking into account that coordination and performance may help or obstruct optimal chronic care. Essential ingredients are research, performance measurement, and quality improvement. The “six pillars of the chronic care edifice” include (1) community resources and policies, (2) healthcare organizations, (3) self-management support, (4) delivery systems design, (5) decision support, and (6) clinical information systems [148, 154, 155]. A systematic review showed that primary care practices are able to implement the CCM and incorporating most or all of its elements is associated with improved quality of care and outcomes in various chronic diseases including diabetes [156].

Glasgow and colleagues developed two scales or surveys to assess the CCM: the Assessment of Chronic Illness Care (ACIC) and the Patient Assessment of Chronic Illness Care [157, 158]. The PACIC and PACIC+ (PACIC extended with six additional multidisciplinary team functioning items to improve content validity) are reliable instruments to measure the chronic care management experiences of patients with diabetes [159, 160]. The PACIC has been translated to other languages [160] and validated in several countries [159, 161, 162] (Fig. 20.1).

Fig. 20.1
figure 1

The chronic care model

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The CCM in Diabetes

In many ways, diabetes care is the prototype for the CCM and became an emblematic clinical scenario to assess its effectiveness, and increasing evidence shows that the CCM provides a framework for optimal diabetes care [156].Table 20.4 summarizes the results of interventions implementing the CCM since 2001.

Table 20.4 The chronic care model (CCM) in diabetes management
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To summarize, diabetes represents an ideal clinical setting to implement the CCM. After two decades of being conceived, however, the amount of studies and, most importantly, the number of health organizations and national health systems who have implemented the CCM are still scarce. Beyond endorsement from international agencies [151] and with remarkable exceptions [172], most of the studies and interventions to implement the CCM have occurred in developed countries; adaptations to preexisting models are the rule, instead of studies devoted to implement the CCM “as it is [173].” Most of the studies cited in Table 20.4 continue to appear in systematic reviews, not only because of importance but also because of scarcity of new trials [174, 175]. Available studies show limitations, including non-blinding of participants, brief follow-up, absence of self-report measures for behavior change, small sample size, inadequate training of health professionals, and absence of registries and electronic medical records [176]. Despite these challenges, in less than 20 years, a large amount of experience using the CCM has accumulated worldwide, in every age group and for multiple diseases. More evidence about the effectiveness of the CCM in diabetes management is essential.

Diabetes as a Complex Disease

Zimmerman, Lindberg, and Plsek described three kinds of problems in the world: simple, complicated, and complex [177]. Simple problems are clearly defined, with straightforward solutions. Complicated problems don’t have straightforward solutions but can be dissected into groups of simple problems. Complex problems have multiple components, commonly not initially perceived and appear during the process of solution. To address complex problems, expertise is important but not sufficient; uncertainty and risk are trademarks. Diabetes management is a complex task. Complexities of diabetic control were recognized five decades ago by Franklin Williams and colleagues, who described the degree in which a variety of continuing intervening factors including (1) biological, (2) psychological, (3) appropriateness (and timeliness referring to clinical inertia) of medical recommendations, (4) adequacy of diabetes education (from a pedagogic to an andragogic approach in adults), (5) patient’s resources (cognitive, socioeconomic, motivation, health literacy), and (6) family and social support, converge to achieve the lifetime challenge of day-to-day control [178]. Despite these arguments, reductionist approaches abound and prevail in diabetes management.

To illustrate the complexities of diabetes management, Khunti identified 54 factors associated with effective delivery of care: 23 were practice-related, 14 were patient-related, and 20 were organizational [179]. Table 20.5 summarizes the highest-ranked factors among the 54 original, based on 5 assessment methods: literature review, brainstorming, focus groups, and key informants – general physicians, nurses, and patients.

Table 20.5 Main factors affecting outpatient diabetes management
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Countless efforts have failed and continue to fail from denial of this reality. Recognition of complexities of diabetes care starts by identifying the three components of successful diabetes management: (1) patient activation, (2) self-care, (3) support. Each one is essential to achieve the desired outcomes; all of them are directly related to the crucial role and responsibility of people with diabetes and their families. Self-care and support are associated to the capacity to deliver multidisciplinary, patient-centered care, including diabetes self-care education and support. The absence of any one of these components leads to clinical failure, waste of economic resources, and overall dissatisfaction from patients, their families, payers, and providers.

Patient Activation and Its Measurement

Patients unable or unwilling to move in the right direction are very unlikely to achieve the goals of treatment established by evidence-based medicine, even in the best professional environments. Ideally, therefore, it would be desired to explore or assess the level of patient activation. Based on her experience about the unwillingness of health systems to accommodate with her needs as a patient, in 2004 Hibbard and colleagues devised the Patient Activation Measure (PAM), a tool for gauging the capacity of patients to advocate for themselves as they proceed through a medical experience [180]. The original scale had 22 items, which assessed patient self-reported knowledge, skill, and confidence for self-management of one’s health or chronic condition [181]. On further analysis, the PAM was reduced to a 13-item measure which has been translated to other languages and validated in the assessment of a variety of chronic conditions [182,183,184,185]. Patient activation has been significantly related to health outcomes, in patients with chronic diseases, including diabetes [186, 187]. The PAM has become the gold standard to understand the role of people with chronic conditions in their own health and is likely to be the focus of the next generation of interventions to support informed consumer choices [188].

Self-Care Management

In 1980, Donnell Etzwiler recognized the increased demand of sustained care for chronic disease management, the importance of medical teams, and the main evolution in their development: to include the patients [189]! Don reflected that this had come about not only from the chronic nature of many diseases but also by the number of daily tasks that (patients) are frequently required to carry out. He also stated that to address the health needs of people with diabetes requires developing comprehensive healthcare teams including physicians, health professionals, patients, family members, and involving the community [189]. Self-care was recognized as an essential component of all the pioneering models of diabetes management [5, 6, 10, 11], and a variety of interventions including “teaching machines” (combinations of printed text and still pictures) were proposed since the 1960s [190]. Early efforts were based on prescriptive, pedagogic approaches in which patients were to “be instructed to report” with their physicians; other health professionals were discarded [191]. The consistent failure of traditional diabetes education programs to improve patient self-care, documented since the 1970s, encouraged exploration of innovative approaches [192]. Lorig and Wagner stressed the importance of collaborative relationships between patients and health professionals and the need to share complementary knowledge and authority in the healthcare process, with health services as organizers and financial supporters of these new roles [149, 193]. Many patients are overwhelmed by the multiple, continuous, annoying demands and unpredictable results of diabetes management [194]. Facilitating strategies include asking questions, identification of “sticking points” of self-care, goal setting, action planning for change, involvement of family and friends, follow-up, problem-solving, and nourishment of coping skills [194, 195]. Diabetes self-management and support education (DSMSE) has become essential in structured diabetes care and is brilliantly addressed in Chap. 26 of this book. Self-management interventions in people with diabetes receiving self-care management, especially delivered in compact programs with sessions closely grouped together, have shown advantages in glycemic control compared to interventions with an educational approach [196, 197]. Self-management training has higher medium-term efficacy than didactic diabetes education [198]. Self-management is highly dependent from collaborating forces at four levels, according to the ecological model of self-care by Fisher and colleagues: (1) personal factors, reflecting the physical and mental status of patients; (2) immediate relations, with family members and friends, at school and work; (3) health systems; and (4) social determinants of health [199]. After more than three decades, “inclusion of patients” is increasingly recognized but at the same time denied in the real world. The importance of self-care is an undeniable component of success. Integrating DSMSE in routine diabetes care is the essence of person-centered care [200]. “Although the achievement of evidence-based clinical goals reduces the risk of morbidity and mortality in type 2 diabetes, delivery of community practices and referral centers often falls short of these goals [201].” Multiple misconceptions and barriers to integrate self-management support into clinical practice include (1) “we’re already doing this”; (2) inability, disinterest, and disdain to address skill deficits; and (3) the need for organizational change [202]. “By comparison to other therapies, DSMSE appears to be the Cinderella of diabetes management...but with greater collaboration, leadership and direction, Cinderella really can become the belle of the ball [200].”

Support

Besides new medicines, main challenges in diabetes outpatient management include (1) recognizing and addressing its complexities; (2) developing, implementing, and sustaining improvements in healthcare systems; and (3) broadening the definition of the “office,” reminding that a year has 8760 hours and, in the best possible situation, patients have a very limited amount of time at physician’s offices [203]. Essential components of structured diabetes outpatient management include (1) targeting patients at high risk, including intensively reducing A1c levels ≥9.0%, blood pressure ≥160/95 mmHg, and foot care in patients at high risk of foot ulcers [204, 205]; (2) diabetes registries for data collection, reporting, support, and quality improvement [205,206,207,208,209]; (3) local physician champions with specific interest in diabetes and chronic care management, the responsible to coordinate the implementation of the patient-centered medical home [205, 206]; (4) team management involving primary care providers, nurse practitioners, dietitians, and “physician extenders” [210,211,212]; and (5) health coaching to make sure that patients understand the care plan involving “knowing their numbers,” shared decision-making, promoting behavior change, and medication adherence [213]. Health coaching has greatly evolved as an important resource in diabetes self-management and care [214]. Diabetes health coaching improves glycemic control, reduces distress, and increases medication concordance and adherence [215, 216]. Diabetes coaching models comprise (1) personal case management and monitoring; (2) diabetes self-management education and support; (3) behavior modification, goal setting, and reinforcement; and (4) general psychosocial support [214]. Technology has leveraged to facilitate each component of diabetes coaching; its rate of development surpasses advances achieved in other major areas of research [217]. Understanding, development, and implementation of effective interventions for patient support, including diabetes coaching, has become a major challenge and, at the same time, a huge opportunity to link the advances of evidence-based medicine with everyday clinical practice.

Conclusions

Establishing the best evidence is not the same as implementing the best practice though the former does provide a basis for the latter.

Philip Davies [218]

Randomized controlled trials, meta-analysis, and systematic reviews have confirmed that unstructured community care is associated with poorer follow-up, worse glycemic control, and greater mortality [176]. This is the case of health systems reluctant and resistant to change the acute care approach in diabetes management like Mexico, where three decades of ill-devised, unstructured, short range, and low resource efforts have not been able to improve clinical outcomes or to reduce diabetes morbidity and mortality [219, 220]. By comparison, worldwide experiences accumulated over three decades have documented the effectiveness of diabetes care in primary practice to reduce risk factors, improve the process of care, decrease referrals to specialized care, and increase the number of consultations when complex, multifaceted interventions and organizational interventions that facilitate structured and regular review of patients are established, in addition to patient education and with support of nurses and health professionals [26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48, 221]. The results of randomized controlled trials have demonstrated that achieving the goals of metabolic control by lowering glucose, blood pressure, and LDL cholesterol reduces the risk of microvascular and macrovascular diabetes complications [222]. Nevertheless, most diabetic patients do not meet these recommended goals; prevailing and persistent structure and process deficiencies in primary care impede the achievement of outcomes. Studies of the level of diabetes care provided “in the real world” and especially in primary care where the vast majority of patients are seen continue to show that performance levels are highly suboptimal from what is recommended [223]. Challenges of diabetes translation, starting with the urgency to change healthcare systems, were described by Anderson since 1991, but a large proportion of persons with diabetes worldwide continue to be treated “as usual [224].” Establishing effective, sustainable, long-term outpatient diabetes management programs is one of the greatest challenges in this era.

Multiple-Choice Questions

  1. 1.

    Initial experience of hospital diabetes clinics in Europe showed that:

    1. (a)

      It was absolutely feasible to treat all patients with diabetes.

    2. (b)

      Every patient could receive treatment from highly trained specialists.

    3. (c)

      Nurses and dietitians were not required.

    4. (d)

      Physicians were the most important elements of success.

    5. (e)

      Clinics became overwhelmed, resulting in long waiting times and dissatisfaction.

  2. 2.

    Successful clinics are the ones:

    1. (a)

      With the most qualified medical specialists

    2. (b)

      Who had the vision and were able to offer comprehensive services

    3. (c)

      Charging the highest fees for their services

    4. (d)

      In which patients could be admitted to an hospital

    5. (e)

      Having access to the newest medications

  3. 3.

    Diabetes management from a paternalistic approach:

    1. (a)

      Is essential to make patients follow physicians’ orders

    2. (b)

      Has been shown to reduce the risk of acute complications

    3. (c)

      Reduces the risk of chronic complications

    4. (d)

      Has received high levels of satisfaction from patients and their families

    5. (e)

      Has never been assessed and is associated with acute and late complications

  4. 4.

    Planning of diabetes services:

    1. (a)

      Needs to be broader beyond those available in most centers

    2. (b)

      Requires procuring for new medications

    3. (c)

      Must be based on the expertise of specialists

    4. (d)

      Occurs exclusively at the medical office

    5. (e)

      Is not important, patients may attend whenever they want

  5. 5.

    Implementation of a model based on the DCCT in clinical practice requires all the following except:

    1. (a)

      Allocation and effective use of resources

    2. (b)

      Standards of care and quality assurance

    3. (c)

      Training and continuing education

    4. (d)

      Research and evaluation

    5. (e)

      Recognition that patients are unable to self-manage

  6. 6.

    Outpatient diabetes management:

    1. (a)

      Is feasible, acceptable, and effective

    2. (b)

      Produces significant improvements in A1c

    3. (c)

      Does not increase the frequency of hypoglycemia

    4. (d)

      Is not inferior to management in hospital clinics

    5. (e)

      All of the above

  7. 7.

    Comorbidity:

    1. (a)

      Should be treated by different specialists

    2. (b)

      Is very uncommon

    3. (c)

      Has no impact on diabetes management

    4. (d)

      Is increasingly frequent, “the disease of the twentieth century”

    5. (e)

      Is never been more important than diabetes

  8. 8.

    Compared with people without diabetes, the prevalence of comorbidity in patients with diabetes:

    1. (a)

      Is very rare

    2. (b)

      Is lower

    3. (c)

      Is equal

    4. (d)

      Is slightly higher

    5. (e)

      Is more than double

  9. 9.

    The chronic care model:

    1. (a)

      Recognizes that outcomes are largely dependent on patients and their families

    2. (b)

      Depends on the availability of all the necessary medications

    3. (c)

      Recognizes the preeminence of physicians in all the decisions of management

    4. (d)

      Involves fragmentation of services

    5. (e)

      Is important but very expensive and complicated

  10. 10.

    Diabetes management:

    1. (a)

      Is simple and straightforward

    2. (b)

      Is complex but outcomes are certain

    3. (c)

      Is complex and outcomes are uncertain

    4. (d)

      Depends exclusively on physicians’ expertise

    5. (e)

      Is independent of patients’ resources

Correct Answers

  1. 1.

    (e) Clinics became overwhelmed, resulting in long waiting times and dissatisfaction.

  2. 2.

    (b) Who had the vision and were able to offer comprehensive services

  3. 3.

    (e) Has never been assessed and is associated with acute and late complications

  4. 4.

    (a) Needs to be broader beyond those available in most centers

  5. 5.

    (e) Recognition that patients are unable to self-manage

  6. 6.

    (e) All of the above

  7. 7.

    (d) Is increasingly frequent, “the disease of the twentieth century”

  8. 8.

    (e) Is more than double

  9. 9.

    (a) Recognizes that outcomes are largely dependent on patients and their families

  10. 10.

    (c) Is complex and outcomes are uncertain