Health Care for Persons with Non-Insulin-dependent Diabetes Mellitus: The German Experience

Definition of Treatment Goals

Most patients with NIDDM in Germany are elderly. Ratzmann [1, 2] concluded in a detailed epidemiologic survey that “more than 65% of all diabetic patients are older than 65 years at the time of diagnosis.” For most of these patients, NIDDM is only one facet of their multimorbidity. Therefore, individualizing therapy for patients with NIDDM is crucially important. For the younger patient group, near normalization of glycemia and other forms of metabolic control are the basis of prevention and progression of microangiopathy (and possibly macroangiopathy as well). As patients age, preventing diabetes-related symptoms is a more important treatment objective than near normalization of metabolic measures, body weight, and so forth. For diabetic patients, regardless of life expectancy, prevention of acute complications (hyperglycemic emergencies and severe hypoglycemia) and of complications from the diabetic foot syndrome is mandatory. In addition, blood pressure control still plays an important role in the prognosis of these patients. Hence, rational treatment of NIDDM is based on the definition of individual therapeutic goals, which ideally are discussed in detail with the patient and documented in the patient's medical chart.

Nondrug Treatment

The primary therapy for NIDDM is nondrug treatment based on nutritional recommendations (mainly targeted to appropriate caloric intake) and increased physical activity. A major problem with this therapeutic strategy (which is the only strategy based on sound pathophysiologic grounds) is the difficulty in motivating patients to change their nutritional patterns and lifestyle. This difficulty has led to the excessive use of oral antidiabetic agents [3].

We searched the literature for useful methods with which to encourage use of nondrug therapy in patients with NIDDM and found Appolinaire Bouchardat's marvelous monograph [4], published almost 120 years ago. Bouchardat proposed a therapeutic system based on daily self-monitoring of urine glucose, restricted caloric intake, and increased physical activity. The patients were not given rigid meal plans; rather, they were advised to decrease caloric intake and increase physical activity until they became glycosuria-free. After reaching this goal, a some-what more liberal nutritional intake was allowed along with continued daily glycosuria self-monitoring. This concept includes many of the most modern ideas of patient education: self-monitoring and self-treatment based on patient responsibility and behavioral approaches to improve patient compliance.

The Treatment and Education Program

We have developed a structured treatment and education program for persons with NIDDM to be carried out at the primary health care level, which uses the two methods of individualized therapeutic goals and flexible nondrug treatment. The program was designed by a multidisciplinary task force, including psychologists, educators, nutritionists, and physicians; a group of primary health care physicians in private practice; and patients with NIDDM. After 3 years of development, which included appropriate formative evaluations, a structured program was completed, with a set of teaching materials and guidelines for both medical teams and patients [5]. The program had three main parts: 1) a group education approach for 4 to 8 patients to be held in a general practitioner's office, mainly by physicians' assistants; 2) four structured teaching units of 90 minutes each at weekly intervals, targeted to the main treatment goals; and 3) systematic documentation.

The curriculum for the teaching sessions uses group interaction techniques. The objectives cover nine areas of patient education: basic information, metabolic self-monitoring, reasons for increased blood glucose levels, oral hypoglycemic agents, diet, foot care, physical activities, sick-day rules, and late-onset complications. To activate the emotional, cognitive, and sensorimotor levels of learning, each session includes an experiential, a theoretical, and a practical aspect. During the first session, patients are introduced to the system of group discussions: They tell about their diabetes history; are informed about diabetes, in general, as well as their individual diabetic condition; and learn to practice glycosuria self-monitoring with test strips. The patients are then encouraged to measure their glycosuria during the next week 3 times daily after their main meals and to record their findings in a log book, which is provided. When the patient achieves satisfactory metabolic control, postprandial glycosuria self-measurements are decreased to twice a week.

During the second session, the patients' log book entries and experiences are presented and discussed. Ways to achieve satisfactory metabolic control—for example, by changes in nutrition and by weight reduction—and the advantages of nondrug therapy are explained. Nutritional recommendations are as simple as possible: Patients are trained to differentiate between nutrients that are recommended and not recommended, particularly with respect to calorie content.

The program is designed to motivate patients in several ways. Complex dietary rules and regimens are avoided. Patients are encouraged to experience the short-term effects of nutritional changes by glycosuria self-monitoring—for example, the substantial improvement in glycosuria after the loss of only a few pounds of body weight and the immediate worsening of glycosuria after a meal rich in simple carbohydrates. Unrealistic and unjustified therapeutic goals such as ideal body weight and normoglycemia in the elderly are avoided. The possibility is also discussed that insulin therapy might not become necessary if nondrug therapies are strictly followed. Sulfonylurea drugs are withdrawn to protect patients from hypoglycemia while they change their nutritional intake behavior. Further, this therapeutic intervention is in accordance with recommendations for periodic withdrawal of sulfonylureas to establish whether such treatment is necessary at all.

At the beginning of the next two sessions, patients' experiences with nutrition, weight change, and glycosuria self-monitoring during the past weeks are again presented to and discussed by the group. The main topics of the third session are foot care and physical activity. During this session, the doctor examines the patients' feet. At the fourth session, sick-day rules are discussed, and finally, the patients are told about the necessary regular follow-up examinations for diabetes control and complications that are to be done (depending on individual needs) by the physicians responsible for their care. Patients will therefore know which tests should be done and are actively encouraged to ask their doctor to make the appropriate arrangements.

Both physicians and their assistants receive guidelines about their functions and responsibilities during the program. Additionally, each practice is provided with various materials for use during the program, such as a series of 23 colored flip charts showing the main objectives of the four teaching sessions, 40 photographs of different food items (each representing 100 kcal), diabetes-related question cards to evaluate patient knowledge during the program, memory cards for the educator that are used as a guide through the curriculum, patients' log books, a book for patients summarizing the program contents, and manuals about organizations. The set of materials is generally available in the German language (5; order by ISBN number) and in several other languages (available from the Zentralinstitut fur die kassenarztliche Versorgung in der Bundesrepublik Deutschland, Projektburo fur Schulungsprogramme, Herbert-Lewin-Strasse 5, D-50931 Koln, Germany; telephone: 49-221-4005102; fax: 49-221-408055).

Evaluation and National Implementation

The efficacy of this newly developed program was documented in a prospective, controlled trial at the primary health care level, which included a follow-up of patients after 1 year [6]. The program was effective in promoting weight loss, had a 50% reduction in oral antidiabetic agent use, and had an overall improvement in various aspects of diabetes care.

As a further step directed toward national implementation of the program, a consensus paper was developed in 1988 by the German Diabetes Association. The paper describes how to organize and carry out a specific post-graduate education program for primary health care physicians and their assistants to enable them to incorporate the program into their practice routine. This postgraduate education course lasts 2 days and includes medical, educational, and organizational aspects. Subsequently, we implemented the program in approximately 100 general practices after the physicians and their assistants took the course. At this stage, no prospective clinical research study has been done. Instead, the program was offered to patients of these physicians' practices as part of routine therapy, and aspects of diabetes care were evaluated in approximately 800 patients at 3 to 6 months after their participation [7]. Again, significant weight loss, a decrease in glycosylated hemoglobin levels, and an almost 40% reduction in oral antidiabetic agent use occurred.

The structured treatment and education program for NIDDM was officially incorporated into the German health care system on 1 July 1991 and included reimbursement of practicing physicians for each patient treated in his or her practice in accordance with the program [8]. As a precondition for participating in the program, physicians and their assistants were required to take the above-described postgraduate course. As of January 1995, more than 12 500 primary health care physicians have participated in these 2-day postgraduate courses, which have been given by more than 350 German diabetologists (members of the German Diabetes Association who had previously participated in a trainers' course for this purpose) during the past 3 years. In addition, approximately 200 000 patients had participated in the program as of January 1995.

Finally, we evaluated the program's efficacy in an unselected sample of practices after the program had become a routine, reimbursed part of primary health care. Patients (n = 179) from 17 randomly selected general practices in Hamburg were re-evaluated 6 months after their participation [9]. As in the earlier evaluation studies, a significant reduction in body weight, an improvement of metabolic measures, and a 50% reduction in the use of oral antidiabetic agents occurred. Data on the expected reduction in hospitalizations and acute complications are still pending, but regardless, we have shown that health care costs are substantially reduced by this program [9].

Ongoing Translation and Further Development

The experience of developing this program, which has taken approximately 10 years, may be a helpful model for increasing standards of care for the millions of patients with NIDDM in other countries as well as for patients with other chronic diseases such as hypertension [10, 11].

More recently, we have developed a structured treatment and education program for patients with insulin-treated NIDDM; the program consists of group education sessions with five teaching units in general practitioners' offices. The program is now implemented and being evaluated in various parts of Germany. Preliminary data on some 200 patients with insulin-treated NIDDM (mean age, 63 years; mean duration of diabetes, 13 years; mean body mass index, 29.7 kg/m²) in 20 practices show a decrease in hemoglobin A_1c levels (mean, 9.5% ± 2.4%) to 7.9% ± 1.3% (P < 0.0001) at a re-examination of patients after 6 months, without substantial increases in body weight or in the incidence of severe hypoglycemia. Based on these evaluations, the health care system in two of the German federal states have begun to reimburse practicing physicians who—after a special postgraduate course for them and their assistants—carry out this treatment and education program for patients with insulin-treated NIDDM. For the first time, practicing physicians are reimbursed per capita for a comprehensive and quality-controlled educational program in the framework of initiating or readjusting insulin treatment in diabetic patients—something that the pioneers of modern diabetology, like E.P. Joslin, declared many decades ago as essential for the long-term success of insulin treatment.

Dr. Flatten: Zentralinstitut fur die kassenarztliche Versorgung, Herbert-Lewin-Strasse 5, 50931 Koln, Germany.