Control of insulin-dependent diabetes with portable miniaturized infusion systems.

A method of insulin therapy that appears to achieve better control of diabetes than present conventional methods is the use of insulin infusion devices--either glucose-controlled feedback (closed-loop) systems or the preprogrammed (open-loop) infusion pump. In view of the problems with implantable glucose sensors, we have worked to develop a miniaturized, programmable infusion system. Its use in insulin-dependent diabetic patients to provide either intravenous doses or a continuous subcutaneous insulin infusion resulted in significant reductions in blood glucose levels, glycemic excursions and 24-h glucose excretion.

Is resistance to ischaemia of motor axons in diabetic subjects due to membrane depolarization?

The reasons for the resistance to ischaemia of peripheral nerves in diabetics are not well understood. We have now explored whether axonal depolarization underlies this phenomenon, as has previously been proposed. Resistance to ischaemia was determined by the new method of "threshold tracking". This method revealed an increase in excitability of the peroneal nerve at the popliteal fossa during ischaemia, and a decrease in excitability in the post-ischaemic period. The extent of these alterations in 28 type 1 diabetics without peripheral neuropathy showed a strong correlation with the mean blood glucose concentrations during the last 24 h before examination. To test whether the ischaemic resistance was related to membrane potential, we also measured axonal superexcitability in 11 selected diabetics, since it has been shown that post-spike changes in excitability depend on membrane potential. Changes in excitability of the peroneal nerve were measured in the period between 10 and 30 msec following a conditioning supramaximal compound action potential. Under resting conditions, no differences in the post-spike superexcitability were found between controls and diabetics, despite striking differences in their responses to a 10-min pressure cuff. These observations indicate that membrane depolarization is not involved in the resistance to ischaemia of motor axons in diabetic subjects.

Postprandial blood glucose and its relation to diabetic gastroparesis--a comparison of two methods.

Delayed gastric emptying is known as an important organic cause for brittle diabetes. We proposed the interval from the start of a meal to the rise in blood glucose, defined as blood glucose latency (T BG) as an index for gastric emptying and a non-invasive test for diabetic gastropathy. In order to validate this test we compared it in 22 type 1 diabetic patients with an established scintigraphic method for the measurement of gastric half-emptying time (T1/2) and found the following correlation: T BG = 4.4 + 0.162 x T1/2; r 0.79, P < 0.001. We therefore suggest measuring the blood glucose latency as a simple non-invasive screening method.

Screening of diabetic patients for microalbuminuria in primary care--The PROSIT-Project. Proteinuria Screening and Intervention.

The PROSIT (Proteinuria Screening and Intervention) Project started in 1993 in order to obtain data on the prevalence of micro- and macroalbuminuria in diabetic patients treated in primary care, to establish an easy screening programme for microalbuminuria, in which also diabetic patients can participate in self-responsibility, and to implement a specific intervention programme for incipient nephropathy. In 58 representative doctor's offices 647 diabetic patients were included, who performed at home self-tests for microalbuminuria on three days within one week using the early morning urine and a newly developed qualitative immunologic test-strip for microalbuminuria. After storage they returned the same urine samples to their doctors' offices for semiquantitative retesting with the immunologic test-strip Micral-Test II. In case of positive results the proteinuria dipstick Combur-9-Test was applied in order to exclude other causes of positive microalbuminuria (e.g. urinary tract infection). Data of 569 patients (6% Type 1, 88% Type 2 and 6% secondary diabetes) could be analysed. Both qualitative self-testing for microalbuminuria at home and semiquantitative retesting in doctors' offices were found to be feasible. Based on semiquantitative retesting the prevalences of microalbuminuria (macroalbuminuria) were 19.6% (0%) in Type 1 diabetes, 17.2% (10.8%) in Type 2 diabetes and 11.7% (7.8%) in secondary diabetes. Type 2 diabetic patients showed a clear correlation between albuminuria and diabetes duration, HbA1c, serum creatinine, triglycerides as well as micro- and macrovascular complications. 227 patients with micro- or macroalbuminuria were included into the ongoing PROSIT intervention programme.

DIABCARE Quality Network in Europe--a model for quality management in chronic diseases.

The DIABCARE Q-Net project developed a complete and integrated information technology system to monitor diabetes care, according to the gold standards of the St Vincent Declaration Action Program. This is the first Telematic platform for standardized documentation on medical quality and evaluation across Europe, which will serve as a model for other chronic diseases. Quality development starts from the comparison of diabetes services, based on the key data on diabetes care in the basic information sheet. This is a 141 field form, which is to be completed once a year for each patient under the care of the diabetes team. The system performs an analysis of the local data and compares the data with peer teams by means of telecommunication of anonymous data. These data are collected regionally. At the next level these regional data are compared on a national basis across Europe using dedicated communication lines. National data can be compared transnationally by the use of the Internet and the DIABCARE benchmarking servers. These different lines are used according to the necessary security standards. Medical data are transferred via dedicated lines, aggregated data via the Internet. The architecture follows the open-platform concept in order to allow for heterogeneous technical environments. Already at the start of the project, the necessity for expanding the quality approach to telemedicine methodology was identified and included. For each level, specific programs are available to improve the performance of diabetes care delivery: DIABCARE data as client and DIABCARE server as regional and DIABCARE 'international server' as transnational server. Functioning pilots were established across all levels. The clients have been linked to the servers on a routine basis. According to the open architecture design, the various countries decided on different systems at the entry point: full system--Portugal; fax systems--Italy, Bavaria; implementation into doctor's office systems--Norway; paper forms and chip cards--France. This system can improve the local, regional and national diabetes care. Initiatives in several countries proved the feasibility of the system. The most extensive use, from Portugal, will be reported later in this paper. The exploitation of the DIABCARE Q-Net system will be performed with the DIABCARE International European Economic Interest Grouping as a co-ordinator and several commercial companies as contractors to market the products inside the system. The key project participants are: DIABCARE Office EURO, DIABCARE Portugal, DIABCARE France, DIABCARE Bavaria, DIABCARE UK, DIABCARE Netherlands, DIABCARE Norway, DIABCARE Italy, DIABCARE Sweden, DIABCARE Austria, DIABCARE Spain, GSF Research Centre for Health and Environment, FAST Research Institute for Applied Software Technology, Tromsø University Hospital, Stavanger Technical College, Technical University of Ilmenau, World Health Organisation (WHO), Regional Office for Europe.

Quality management in psychiatry.

Over the past 50 years, treatment possibilities in psychiatry have drastically improved, but the results we actually achieve under everyday treatment conditions fall far short of what could be accomplished. Quality management represents a suitable method of reducing this gap. Although it has been successfully practiced in other medical disciplines for a long time, its implementation in psychiatry has previously been restricted to pilot projects. Quality management programs in psychiatry have been slow to be accepted because, up to now, only a few mental health professionals have received training in quality management techniques. In order to compensate for this information deficit and to familiarize psychiatrists and other mental health care workers with this increasingly important topic, we will provide in this paper a brief survey of the most important principles and techniques of quality management. This information should encourage psychiatrists to apply this new method to their own areas of responsibility. The results of one of our own studies on schizophrenic outpatients, which are presented at the end of the paper, are intended to show that the outcome can be improved and costs reduced by implementing quality management programs in psychiatry.

The implementation of a quality-net as a part of the European project DIABCARE Q-Net.

DIABCARE Q-Net is a European project with a consortium of partners in healthcare, industry, and research, which has the overall target of improvement in diabetes care by aggregation, evaluation, and feedback of anonymized patient data with the tools of modern telematics, resulting from the initiative of the St. Vincent-Declaration, St. Vincent, Italy. Based on standardized tools for quality improvement in diabetes care, i.e., the Basic Information Sheet (BIS) and recently developed data entry and feedback software (DIABCARE Data for Windows), DIABCARE Q-Net as a part of the Telematics Applications Program of the European Commission will improve diabetes care and disease management by the implementation of a quality network. Therefore, the project implements regional, national, and central nodes for processing of diabetes quality indicators. All participating centers (GP's and clinics in Europe) get feedback by standardized benchmarking. The pilot testing and the state of implementation of our network confirm the importance of improving the quality of life of diabetic patients in all participating countries.

Advanced health care initiatives in Europe on quality development, epidemiology and medical documentation.

Since the St. Vincent Declaration was published in 1989, several different but logically linked activities have been initiated. In addition, there are projects in adjacent fields supporting each other by exchange of information and partial co-operation. This paper provides an overview of their structure and describes the different projects.

[The early breakfast--an unknown pitfall in the treatment of type-I diabetes mellitus]. / Das vorverlegte Frühstück--eine unbekannte Fallgrube bei der Behandlung des Typ-I-Diabetes mellitus.

In 15 type I diabetics the mean postprandial rise in blood glucose levels, 90 min after breakfast at about 8 a.m. (the customary time for this meal in hospitals), was 62.2 +/- 34.3 mg/dl, but 90 min after a breakfast which had been put forward by about 1 1/2 hours it was only 2.6 +/- 18.6 mg/dl (P less than 0.001). Seven patients developed hypoglycaemia after the early breakfast, none after the late one. This finding suggests that, to avoid hypoglycaemia after an early breakfast, an additional small meal should be given at about 8:30 a.m. or the insulin content of the morning injection should be changed. The clear connection between the time of the morning insulin injection and the insulin action during the morning explains why, in uninstructed patients who--under their usual daily conditions of starting school or work--are forced to inject insulin early or to eat early, a state of hypoglycaemia may occur.

Glucose control in mobile type 1 (insulin-dependent) diabetic patients by means of a semi-automatic feedback controlled insulin infusion system.

A portable insulin dosing device (Siemens) was used together with a programmable pocket calculator and a glucose analyzer for short-term adaptation of continuous intravenous insulin infusion to blood glucose alterations. A special algorithm was developed which utilizes a given blood glucose value and the glucose rate of change obtained from two to four consecutive samples as input variables. In contrast to current techniques of feedback-regulation, which require continuous glucose monitoring, intermittent blood sampling allows greater mobility of patients. With the semi-automatic feedback system, euglycaemic control was obtained for 12-h periods in ten Type 1 (insulin-dependent) diabetic patients (maximum value 9.50 mmol/l, minimum value 2.83 mmol/l). Severe hypoglycaemia occurred in no case and additional control by glucose infusion appeared to be unnecessary. Light exercise after termination of insulin dose for standard meals led to glycaemic excursions with a rapid decrease (mean 1.08 +/- 0.09 mmol/l), followed by a rebound (0.59 +/- 0.07 mmol/l) in each patient. The amplitude of these excursions decreased with increasing distance from the peak of the meal dose. Comparison of feedback-control alone with feedback by glucose plus preprogrammed dose (4 U/h) at the onset of the test meal revealed lower post-prandial glucose levels (post-prandial maximum +/- SEM: 6.49 +/- 0.18 versus 7.71 +/- 0.79 mmol/l) and a lower infusion rate of insulin for the combined regimen (mean post-prandial maximum +/- SEM: 8.4 +/- 1.2 versus 12.0 +/- 0 IU/h). The system is useful for programming of portable infusion devices and studies based on euglycaemic control in unrestrained patients.

The feedback between monitoring and improvement of quality of diabetes care.

The need for permanent, population-wide, improvement in metabolic care of diabetic patients is generally accepted. This paper highlights some related aspects which must be considered by any health care provider: (1) Monitoring metabolic or other variables in diabetic patients is an essential tool in routine metabolic care, where a "short feedback" between monitored data and medical or behavioral measures is permanently established by the patients themselves, the physicians, the nurses etc. (2) Quality insurance requires the closure of a "long feedback" between informations and interventions, such as conditions, tools, methods, used at the different levels of the care system, from the individual patient to a population scale. (3) Appropriate epidemiological studies are required to program and evaluate the effect of any activity aimed at insuring and maybe improving the quality of care of diabetic patients, especially if one considers the time required to reach "hard end-points" such as the evaluation of patient mortality or the outcome of children from diabetic mothers. (4) The knowledge of incidence and prevalence rates of diabetes and its complications, and of risk factors may stimulate the political and economical recognition of the importance of the disease by health care officials. (5) In this way, the medical recognition is also stimulated within the professional team responsible for the establishment of the "long feedback" of quality insurance at the level of a given method, of an individual patient or of a health care unit, and for the actual implementation of generally accepted knowledge, everywhere in routine care.

Monitoring the targets of the St Vincent Declaration and the implementation of quality management in diabetes care: the DIABCARE initiative. The DIABCARE Monitoring Group of the St Vincent Declaration Steering Committee.

The St Vincent Declaration, a joint initiative on diabetes care and research of the World Health Organization (Europe) and the International Diabetes Federation (Europe), includes 5-year targets for improvement in diabetes outcomes as a central tenet. Accordingly, the establishment of state of the art monitoring and control systems is urged as a basis for the implementation of quality management. As a prerequisite for both targets, a diabetes dataset (fields and definitions) has been agreed to allow common monitoring of diabetes throughout Europe. This dataset has been further developed as the foundation stone of DiabCare, an initiative for continuous quality development in diabetes care. In a formal consensus process using the Delphi method, over 130 European diabetologists from 21 countries contributed to the development of this dataset, which includes fields covering true patient outcomes, intermediate metabolic outcomes, markers of diabetes tissue damage, risk factors, pregnancy, and life-style. The tools for documentation of the quality of health status have been developed in three formats for use in different health care settings. These tools, the DiabCare Diabetes Dataset, the DiabCare Basic Information Sheet, and the DiabCare Computer Program, are designed to allow local feedback-driven improvement in the quality of care, but are also the subject of communication protocols to compare performance between centres, regions, and countries. Whether implemented with or without the benefits of modern information technology, these initiatives can be the basis for both monitoring the targets of the St Vincent Declaration and for implementation of continuing quality development in diabetes care.

Analysis and processing of data in a hospital-based diabetes management system.

Both short-term care (blood glucose monitoring) and long-term care (clinical examinations) of diabetes generate an ample amount of data for each patient. Health care in hospitals has to provide services with respect to both demands. The quality of control depends on obtaining the right finding at the right time and taking the individually adequate measures. These repetitive activities follow to a certain extent standardized algorithms and computer-programs are able to support demands like this; however, up to now no attempts have been made to provide useful tools for this environment. DIALIN is a data-bank especially designed for the use in hospitals or outclinics and Camit is a diabetes management system for advanced evaluation of long-term blood glucose monitoring data. The expert-system DIACONS up to now determines diabetes type and adequate initial therapy from data of patients' history alone; it operates on the DIALIN-databank via SQL. DIALIN has proven to be a useful tool for data-processing in hospitals. Camit was well accepted by patients in a feasibility study. DIACONS has been tested with 83 diabetic patients to provide the correct diabetes-type and the proper initial regimen with a precision of 96% compared to the correspondence between two independent experts. The combination of all three systems is a step towards the Munich Medical Information system MAMIS.