The alarmingly rapid increase in the number of patients with diabetes worldwide, and especially in Germany, is a fact that must be accepted. Parallel to this development, the costs of providing these patients with diagnostic and therapeutic care are rising dramatically. Therefore, suitable health services research methods are needed to demonstrate the successful and cost-effective use of treatment strategies in everyday practice. The evaluation should not focus on the quality of care in individual practices, but rather on the summary results at a supra-regional level, in order to make the quality of care for patients with diabetes mellitus transparent nationwide and thus contribute to ensuring good patient care in the long term.

>> In Germany, over the last ten years, the treatment of patients with diabetes has largely shifted from inpatient to general practice and to specialized outpatient care, i.e., to diabetes specialist practices. There are currently an estimated 1,100 specialist diabetology practices in Germany. At the same time, the structures and processes in the specialist practices have been optimized to such an extent that the performance of outpatient diabetology – measured in terms of the number of patients cared for – has probably increased significantly. However, the consequences of this development – and also the performance/quality of the work of the specialist practices – have not yet been systematically evaluated. The data collected as part of the disease management programs (DMPs) also only allow for limited conclusions in this regard.
Especially in the case of type 2 diabetes mellitus, there is a significant need for health services research that addresses the quality of care, the cost-benefit ratio, and the implementation of new scientific findings in practice. This is due to the serious and costly complications associated with diabetes, which can be prevented or delayed through good metabolic control. In a healthcare system as highly developed as ours—and from a professional perspective—it is incomprehensible that targeted health services research on this topic has been virtually nonexistent in Germany to date.
If a practicing diabetologist wants to reflect on their work in a scientific sense and evaluate the quality of their daily work, they must do so themselves, in the spirit of "after-work research." The still clear, almost exaggerated, division in Germany into outpatient care by practicing diabetologists and inpatient care in specialized centers is not helpful in this regard either.
It can therefore be stated that, to date, there has been a lack of a suitable (communication) platform for the transfer of new scientific findings into the practice of patient care. Equally important is that the problems and questions arising from practice are reflected back in a targeted and systematic manner at other levels of research. The results of so-called evidence-based medicine are predominantly generated from study populations that do not correspond to the clientele present in the practices. Establishing such a feedback process would realize an extremely important missing part of the entire circle. The therapist who "works" directly with patients experiences a different reality than the scientists in the other research levels; this reality often does not correspond to the "study situation." However, the diverse observations and experiences of the treating diabetologists/family doctors have not yet been systematically recorded and analyzed in any way.
The example winDiab
A first step toward focused healthcare research in this area was taken with the establishment of the Scientific Institute of Outpatient Diabetologists – winDiab. In the future, winDiab will – in addition to producing annual reports – address relevant issues in outpatient diabetology, thus providing the missing healthcare research based on the daily patient care practiced in the participating winDiab partner practices.
winDiab is financed exclusively (!) by the participating practices themselves; there is no funding from the pharmaceutical industry. winDiab's shareholders and partner practices are exclusively physicians who work in their own specialized diabetes practices.
winDiab thus provides a scientific platform for patient-centered healthcare research and plays a prominent role in implementing the current state of knowledge in diabetes prevention, diagnosis, and treatment in everyday life. The evaluation of the obtained results aims to address the previously rather poor representation of this level of care at scientific conferences and in publications.
The institute also serves as a communication hub between the participating practices. Observations or questions that arise in the daily treatment of one partner practice are forwarded to the other partner practices. By collecting feedback through winDiab, these are presented to the diabetes community as "observations": For example, analyses were carried out to determine the average daily insulin dose for type 2 patients, or to determine whether or not patients treated with a new medication really experience the impressive weight loss observed in studies. If not, why is this? Are patients not taking the medication as prescribed by the manufacturer, or is it not being prescribed to the patient population examined in the studies? Are they receiving other "interacting" medications at the same time?
Only a systematic approach to data collection and evaluation can prevent such a procedure from being discredited as "observational use." The transparent and scientific approach of winDiab aims to ensure that studies at this level of care are taken seriously. By presenting this data to the "scientific" world, the one-way street in knowledge transfer with a top-down mindset is avoided and a new type of collaboration between all levels of care is established.
Annual Report 2007
The first annual report for 2007 summarizes information from 51 diabetes specialist practices with a total of 84 diabetologists from across Germany. It is based on data collected using a one-page questionnaire in February/March 2008. The questionnaire did not collect any patient-related data, but only cumulative information on patient treatment and training, as well as on the characterization of the practice. Of the 56 winDiab partner practices, 51 practices completed and returned this questionnaire. For treatment data, the results from the second quarter of 2007 were collected, representative of the entire calendar year 2007; for information on training courses and participants, the entire year 2007 was collected. The data from the questionnaires were transferred to an Excel file and checked for plausibility. In cases of missing information or questionable plausibility, a follow-up telephone follow-up was conducted. The aim of this first annual report was to provide a description of the current state of practice in diabetology in the sense of a depiction of structural quality (and partly also process quality).
Individual results:

1. The diabetes specialist practice (DSP)
Diabetes specialist practices (DSPs) are an important structural element for ensuring optimized quality of care for patients with diabetes. They are referred to as Level 2 care and complement the Level 1 care provided by general practitioners. A DSP sees itself as a contact point for high-risk patients and, on the other hand, treats patients referred to it from Level 1 care for a defined period of time.
2. Medical staff
A DSP is led by one or more diabetologists and must meet certain quality criteria, which are monitored by the committees of the respective association of statutory health insurance physicians (diabetes commission). These criteria vary considerably between the individual federal states! The diabetologist(s) in question have participated in an 80-hour continuing education course run by the DDG (German Diabetes Society) or have completed further training in accordance with the continuing education regulations of the relevant medical associations. Every diabetologist must regularly provide evidence of annual continuing education. Furthermore, rhetoric and didactic seminars are mandatory. Continuous continuing education for diabetologists is an important factor in ensuring high-quality treatment for patients. Despite the required similar quality characteristics, DSPs differ considerably from one another. For example, there are DSPs that care almost exclusively for patients with diabetes, while there are also practices with general practitioner status that primarily care for non-diabetics.
3. Diabetes advisors
The care team at a DSP includes at least one qualified diabetes educator (DDG) or qualified diabetes assistant (DDG). Special requirements are also placed on the non-medical practice staff: In addition to competence and specialist knowledge, they are expected to possess teaching skills in dealing with people who must be taught complex knowledge about managing diabetes in their everyday lives. A total of 81 diabetes educators (average 1.7) work in the 51 practices. Of these, 27 practices have one, 16 practices have two, 4 practices have three, 1 practice has four, and 1 practice has six.
A DSP requires at least one diabetes educator who, through their one-year training, has acquired the authorization to conduct counseling and training courses for patients with type 1 and type 2 diabetes using various treatment concepts (diet, tablet or insulin treatment, insulin pump therapy). The main task of the diabetes educators and assistants – in addition to providing counseling – is to educate patients with type 1 and type 2 diabetes with and without insulin, to care for women with gestational diabetes, and to educate patients with hypertension. The one-year training course is conducted by the professional association and certified with a final examination.
The diabetes educator's participation in the quality circle, in which general practitioners and diabetologists meet at the local level for regular professional development and to exchange experiences, is one way to foster understanding of the problems of patients with diabetes and improve care. The development of training and treatment strategies for individual patients with specific problems proves particularly beneficial in this context, as direct contact with the referring physician is usually available.
4. Diabetes assistant
In addition to the diabetes advisor, the team also includes diabetes assistants. These are usually medical assistants by profession and have also completed further training according to the guidelines of the German Diabetes Association (DDG). Diabetes assistants are authorized to provide education to patients with type 2 diabetes.
A total of 86.5 diabetes assistants work in the winDiab partner practices (average 1.7). 17 practices have one, 15 practices have two, 7 practices have three, 3 practices have four, and 1 practice has five.
5. Other diabetes-specific staff
This includes professions such as wound management, podiatrists (foot specialists), and consultants/assistants in training. A total of 101.3 such employees work in the partner practices (average 2.7). Ten practices have one employee, 11 practices have two, five practices have three, four practices have four, three practices have five, and one practice has eight or ten additional diabetes-specific employees.
6. Practice equipment
The necessary equipment for DSPs is usually precisely defined in the regional contracts for the implementation of the DMP Diabetes Mellitus Type 2 or Type 1. A particular focus of DSPs is the conduct of patient education sessions (see below). Suitable facilities for both group training and individual consultations must be available for this purpose.
Training materials and programs with the various curricula are available, supplemented by diagnostic equipment for measuring blood glucose, blood pressure, and laboratory parameters (e.g., HbA1c as a parameter for describing metabolic control) according to quality standards within the practice rooms. This also includes equipment for diagnosing autonomic and peripheral neuropathy, as well as cardiovascular diseases, including arterial occlusive disease.
Of the 51 winDiab partner practices, 45 have already implemented a quality management system with external auditing or are in the process of doing so. In this context, the practices have committed to establishing close collaborations with specialists from related disciplines (cardiology, angiology, ophthalmology, gynecology, etc.) and with relevant non-medical professionals (e.g., psychologists).
6. Patients
The total number of patients with diabetes cared for in the 51 DSPs during the survey period (one quarter) was 53,587 (mean: 1,072). Depending on whether the practice is a pure DSP or a more diabetological general practice, there is a considerable range, with a minimum of 130 patients cared for and a maximum of 3,097. The majority of patients (62.2 TP3T) are treated with insulin: a total of 33,345 (mean: 710, range: 84–2,115).
In the daily work of a DSP, four different patient groups are cared for: patients with type 1 diabetes, patients with type 2 diabetes (including patients with coronary heart disease, hypertension or diabetic foot syndrome), patients with gestational diabetes and patients with other forms of diabetes.
7. Type 1 diabetes
This patient group accounts for approximately 10% of the total number of patients in Germany. Since patients with type 1 diabetes are primarily cared for in DSPs, their share of the total patient population is correspondingly higher at 20.3% in DSPs. The total number of these patients (including LADA) was 10,872 (mean: 213, range: 20–615). Of these patients, 2,024 (18.6%; range: 3–186) are treated with insulin pump therapy (mean: 40.5%; range: 3–186).
8. Type 2 diabetes
Since type 2 diabetes is the most common form of diabetes, it is reflected in the high number of such patients in DSPs (76.5% of the total population). In absolute numbers, this translates to 40,993 patients (mean: 804; range: 75–2,482). Patients with type 2 diabetes referred to a DSP are often high-risk patients who have already developed severe diabetes-related complications. These include cardiovascular disease and diabetic foot ulcers.
9. Type 2 diabetes with coronary heart disease
Cardiovascular diseases are the main cause of reduced life expectancy in these patients. The total number of patients with CHD was 9,495, corresponding to a percentage of 23.2% (mean 206; range 25–610).
10. Type 2 with hypertension
Significantly more type 2 patients were diagnosed with hypertension; a total of 23,281 patients were treated for this condition during the period under review, corresponding to a percentage of 56.8% (mean 506; range 30–1,400).
11. Diabetic foot syndrome
One of the most common complications of diabetes is diabetic foot ulcers, which also requires extremely complex treatment. A total of 2,965 cases were reported, corresponding to a percentage of 5.5% (mean 63; range 2–363).
12. Gestational diabetes
The care of women with gestational diabetes is also one of the core competencies of a DSP. A total of 1,699 such patients were cared for, corresponding to a percentage of 3.2% (mean 35; range 1–131).
13. Other forms of diabetes
Relatively speaking, other forms of diabetes were treated relatively rarely; only 389 cases were reported. The percentage was 0.7% (mean 12; range 1–70).
Conclusion
Given the alarming lack of data on Level 2 care, which is represented by the DSPs, this first annual report from winDiab provides, for the first time, important information on the treatment of patients with diabetes mellitus in Germany. This report will be supplemented by the final 2007 annual report, planned for fall 2008, which will contain data from significantly more winDiab partner practices. This report demonstrates that the performance of office-based diabetologists and their staff is highly relevant for routine diabetes care: Each partner practice cared for an average of more than 1,000 patients per quarter; 66% of the patients treated were receiving insulin therapy; in 2007, approximately 300,000 training hours were provided in the partner practices. These figures demonstrate differentiated and qualified outpatient care for patients with diabetes mellitus in the DSPs.
However, the figures also show that there is no such thing as "the" DSP. Due to regional structures and contractual conditions, DSPs have developed with different service spectrums. The spectrum ranges from highly qualified specialized practices with three diabetologists and five diabetes educators, to group practices with a diabetologist in their portfolio, to small practices that also offer diabetology services due to previous clinical experience. A definitive definition of what exactly constitutes a specialized diabetes practice is still pending.
The 2007 Annual Report provides detailed information on the structural quality and, to some extent, also on the process quality of the DSPs. However, the difficulty of data analysis makes it virtually impossible to provide information on the quality of results at this time. The necessary quality indicators, which still need to be defined, are also missing.
The stated goal of the initiators of winDiab is to motivate significantly more DSPs from Germany to participate in winDiab. In addition, individual projects and SPOT surveys on specific topics will be used to gather results on defined questions. Initial projects include data on gestational diabetes, diabetic foot syndrome, average daily insulin doses, and treatment regimens for type 2 diabetes.
This makes it possible to record and present, step by step, the actual outpatient care of patients with diabetes mellitus in Germany in its entire spectrum.

By: Gabriele Faber-Heinemann, Dr. Matthias Kaltheuner, Dr. Hans-Martin Reuter, Prof. Dr. Lutz Heinemann