Advances in Diabetes for the Millennium: Healthcare Systems and Diabetes Mellitus

Abstract

Diabetes presents a host of management issues to the practitioner. With the increasing role of managed care systems, the care of diabetic patients has created many issues in the relationship of physicians and third-party reimbursement agencies. We predict a progressive evolution of diabetes care in light of these changes. The diabetic population will continue to grow rapidly. Collaborative care systems will expand. The paper medical record will be replaced by electronic documentation. The technology of diabetes care will progress rapidly in providing office and home care for diabetes patients. The increasing cost of these interventions and the growing diabetic population will challenge the reimbursement system. We will have to seek for more cost-effective approaches in light of these factors.

Systems of Care for Diabetes Patients

Introduction

No disease presents as many different management issues for patients and practitioners as does diabetes mellitus. The control of blood glucose levels is but one facet of the treatment of a host of associated conditions, including retinopathy, nephropathy, neuropathy, coronary artery disease, and peripheral and cerebrovascular disease. Acute problems, such as a vitreous hemorrhage, myocardial infarction, or diabetic foot ulcer, may surface at any time as may a sudden deterioration of glycemic control, placing the patient at risk of death from ketoacidosis. Hypoglycemic events often occur as a byproduct of attempts at good glycemic control. Diabetic gastroparesis and diabetic diarrhea afflict the gastrointestinal system. Erectile dysfunction is very common in diabetic patients. Many diabetic patients now are on multiple medications that increase the risk of drug-drug interactions.

Many studies now demonstrate that cardiac risk factors, such as hyperlipidemia and hypertension, must be aggressively treated. The patient must be screened for the development of renal and eye disease. The feet must be examined at each visit. Glucose levels and the response to treatment must be assessed.

Patient self-management is the key to optimal control of diabetes. This requires extensive education of the patient. In addition to the mechanics of glucose monitoring and self-administration of pharmaceutical agents, patients must learn to regulate their diets and exercise patterns. They must learn how to treat hypoglycemia. The implementation of the principles of foot care is essential to avoid foot ulcers. The use of new technologies, such as insulin pumps, creates a much higher order of complexity.

Behavioral change is a key element in treatment. Smoking cessation is essential to diabetic patients because of the heightened risks of microvascular and macrovascular disease. Obesity is a growing problem and needs to be treated with extensive nutritional and behavioral interventions that require total revision of lifestyle.

The above described care for the diabetic patient and for others with chronic conditions is delivered in many ways in the rapidly changing healthcare environment. The term "managed care" refers to a series of programs that were created after 1973 in response to a change in federal law. These programs were a response to a rapid increase in healthcare expenditures arising after the development of Medicare. The increased costs were related to an expansion of benefits, explosion in new technologies, and increased usage rates. The percentage of the national economy devoted to healthcare is presently about 15.6% or 1.4 trillion dollars. The high utilization of healthcare procedures is challenged by studies suggesting considerable geographic variation in practice patterns related primarily to use of local resources, not to optimal processes and outcomes.[1-5]

New Systems and Technology

New technologies for the treatment of diabetic patients are being fused with new concepts being introduced into the managed and nonmanaged care environment. The increasing complexity of treatment options is being combined with the increasing complexity of benefit design. In the 21st century, we can predict the evolution of the following trends.

Rapidly Growing Population of People With Diabetes

There is a rapid increase in the number of people with obesity, the metabolic syndrome, prediabetes, and type 1 and type 2 diabetes. Diabetes is increasing in prevalence worldwide, especially in people of color. Nonwhites are increasing fastest in the US population, according to the Census 2000: 59% Hispanics, 16.2 African Americans, 15.3% Native Americans, 9.3% Pacific Islanders, and 3.4% whites. The current healthcare configuration in this country will not be able to take care of this huge population in its current configuration. It will need to adopt newer models of care and technology to answer the needs of society.

Continuing Evolution of Chronic Collaborative Care Programs as the Principle Means of Caring for the Diabetic Patient

On the basis of several studies correlating disease management programs with improved quality of care and decreased costs, many healthcare systems now offer disease management and chronic collaborative care programs for diabetic patients. As an action following up on the Institute of Medicine recommendations, the Centers for Medicare and Medicaid Services (CMS) in 2001 sponsored 10 demonstration projects for disease management of diabetic patients in various managed care settings. A recent request for proposal released by CMS has expanded disease management demonstration projects to the fee-for-service Medicare population for diabetes, congestive heart failure, and chronic obstructive pulmonary disease. The intent is to enroll 10 of the fee-for-service population. Most importantly, this request for proposal includes provisions for reimbursement of disease management services to health systems and providers on the basis of "pay for performance criteria."

Electronic Patient-Centered, Personal Health Record to Replace the Paper Medical Record and Improve Quality of Care for Diabetic Patients

The healthcare industry is rapidly moving in this direction, stimulated by recommendations by the Institute of Medicine and the active involvement of the current administration. In this model, patient characteristics, indicators, laboratory results, and treatments are in a file owned by the patient and accessible to all providers given permission by the owner. This mechanism will greatly streamline the care of the patient and facilitate the use of emerging technologies.

Alternative Technologies and Sites for Blood Glucose Testing

The introduction of the Chemstrip bG in 1979 introduced a new era of diabetes care. This strip improved the existing technology and led to the ubiquitous use of home blood glucose monitoring as the "gold standard" tool for patients to assess their status and to allow the self-adjustment of insulin, exercise, and nutrition.

In the past 2 years, we have seen the introduction of home glucose strips and monitors that can be used at dermal sites distant from the capillary bed of the finger. There is one available continuous glucose sensor worn on the wrist like a watch and one system available for continuous subcutaneous glucose monitoring. We anticipate the continuing evolution of noninvasive glucose monitoring for the patient at home with automatic transmission to a home computer and a practitioner. This will add a new dimension to diabetes care.

Alternative Insulin Delivery Systems and Oral Agents

We are constrained in our attempts to control diabetes by the limitations of subcutaneous insulin administration. This is not physiological and is subject to significant errors in dosing and great variation in absorption. Banting and Best demonstrated that insulin is absorbed from the proximal small intestine when it has been infused distal to the stomach. Thus, we have known that alternatives are possible.

Inhalable insulin is now in phase 3 trials and should be on the market soon. The action is equivalent to subcutaneous insulin. Several companies are working on developing oral and suppository insulin delivery systems.

Many new oral agents are in development that have mechanisms of action on hormonal systems that we did not know existed 5 or 10 years ago. These agents may be more potent that existing agents and are likely to be used in increasing complex combinations. Some of these agents also promote weight loss, which is increasingly prevalent and difficult to treat.

As we understand the genetic and molecular basis of macrovascular and microvascular diabetic complications, new therapies are being developed that will target these pathways and delay or prevent the catastrophic complications of diabetes.

Connectivity

A recent Gallup Poll revealed that the vast majority of people wants electronic connectivity with their physician, but only a minority of physicians want the same access to their patients. This dichotomy is illustrated by the continuing reliance of most physicians on the archaic paper record. Physicians are being pushed by the government, payers, and patients to migrate to electronic platforms and develop tools to take advantage of the information revolution. There are multiple vendors with tools that can be used, but none of them are yet well developed. This area of practice will develop rapidly as the market demands electronic services. Reformation of current reimbursement practices will occur as practice changes and the market catch up.

Tools for Practitioners

Office practice will change as the available tools change. Physicians will have many more reimbursable procedures and tools to use in their offices. A few examples include:

• Continuous noninvasive glucose monitors with readings downloaded from home or in waiting rooms to an office link, which has information available immediately online.

• Office laboratory measurements of fingerstick HbA1c, lipid levels, and urine microalbumin levels immediately determined at time of visit

• Office digital cameras to image the retina and image-analyze for presence of retinal disease.

• Waiting room interactive computerized questionnaires focusing on diabetic complications and screening for other unrelated conditions. Furthermore, educational sessions will review principles of self-care. Automated pill counts will be performed to assess compliance with drug regimens.

• Screening will be performed for autonomic neuropathy with pupillary and relative risk interval automated testing.

• Body fat analysis will be performed via near-infrared measurement to assess response to therapy and correlation with insulin resistance.

• There will be automated prescription routing with direct imprint to an information chip carrying the full medical history and pharmaceutical regimen of each patient, all directly routed to pharmacies.

• There will continue to be active involvement of support staff of diabetes educators and dieticians in patient care. This involvement will increase through computerized interactive sessions as opposed to the present-day, face-to-face meetings.

Roles for Practitioners

Diabetologists will need to learn to be immunologists. Type 1 diabetes is now recognized as an autoimmune condition in people with certain genetic combinations in which an environmental event has occurred. There are a number of opportunities for intervention in the cascade that leads to diabetes and in the treatment of people with type 1 diabetes. Diabetologists will need to learn what risk factors to evaluate to identify children and adults at risk and which immunomodulators to use for prevention. When a patient who has not been screened for diabetes presents with beta-cell loss, he/she will need to know which immuomodulators to use to reverse the damage, and these may be different from the agents used in prevention. When a beta-cell or partial pancreas transplant is performed to treat diabetes, immunomodulation is needed to prevent graft rejection and the recurrence of the autoimmune phenomenon that led to type 1 disease in the first place.

Physicians treating diabetic patients will increasingly be in the role of advising diabetic patients how to use their benefits and spend their money. Consumer-directed health plans are becoming increasingly common with large deductibles of more than $1000 for individual care and $2500 for family care. Unless preventive care and medications for diabetes are included in the first dollar coverage of health plans, practitioners will increasingly have to advise their patients in what are the most cost-effective tests to do and pharmaceuticals to buy.

Different office settings for patient visits are becoming more common. In the shared medical-appointment model, the physician may see 6-12 patients at a time and take advantage of group learning. This is much more efficient and cost-effective than the standard one-on-one visit and has high patient satisfaction.[5]

Discussion

These are the enormous challenges to the physician involved in the daily management of the diabetic patient. The algorithms exist, and are simplified to checklists of HbA1c 2-3 times yearly, annual retinal exam, microalbumin and lipid levels, encouragement in dietary and exercise regimens at each visit, foot check at each visit, and a yearly full foot evaluation and review of self-glucose-monitoring results. However, these algorithms describe the basic process but not the complexity of the physician interaction with individuals with many different problems, some of which are related and others unrelated to diabetes. Patients are taking a large number of medications. Typically, 1 or more antihypertensives, a lipid-lowering agent, and multiple hypoglycemic agents are the rule. To this, one can add antianginal drugs, perhaps a diuretic, nonsteroidal anti-inflammatory agents, a medication for erectile dysfunction in men, and eyedrops in patients with glaucoma or post vitrectomy. The review of possible drug interactions alone is a considerable endeavor.

The difficult issue of improving healthcare outcomes for patients with chronic diseases, such as diabetes, is continuing to be an issue as resources become more constrained. In fact, there are very little comparative data on healthcare for diabetic patients. The most difficult problem is that there is no national database for many of the process measures that we use (ie, rates of determination of HbA1C, retinal examinations, and foot examinations). Also, there is no national database for clinical outcomes, other than hospital-discharge data for events, such as acute myocardial infarction, amputation, and diabetes out of control. In those areas, we usually have equivalent event and admission rates and a lower length of stay. We have lower rates of admissions for diabetes out of control due to increased outpatient management. In focused studies, there is a wide variation between different areas that are equivalently better or worse than that in other countries.

It is well recognized that there are not enough, and never will be enough, endocrinologists to take care of all diabetic patients. Diabetic patients have multiple medical problems other than those related to diabetes. Primary care physicians will continue to care for the vast majority of diabetic patients. To do this, the marketplace will continue to develop new technologic advances, and healthcare systems will continue to develop disease management programs to backfill the infrastructure that has not yet been created in the vast majority of delivery systems. These programs vary from primitive attempts at case identification and dissemination of guidelines and literature to contract relationships with sophisticated vendors.

Conclusion

In diabetes care, we have a great opportunity to prevent diabetes, and when it occurs, we have the capability to prevent and delay complications and resulting disability. Effort will be made in the outpatient setting as society faces the increasing costs of care for diabetic problems in hospitals. As new technologies and systems of care continue to be developed, it is our hope that rational mechanisms will prevail to best treat the population at risk for and diagnosed with diabetes.