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Objective: Diabetes treatment and teaching programs (DTTPs) for type 1 diabetes, which teach flexible intensive insulin therapy to enable dietary freedom, have proven to be safe and effective in routine care. This study evaluates DTTP outcomes in patients at high risk for severe hypoglycemia and severe ketoacidosis., Research Design and Methods: There were 96 diabetes centers that participated between 1992 and 2004. A total of 9,583 routine-care patients with type 1 diabetes were examined before and 1 year after a DTTP. History of repeated severe hypoglycemia/severe ketoacidosis was an indication for DTTP participation. Before-after analyses were performed for subgroups of patients with three or more episodes of severe hypoglycemia or two or more episodes of severe ketoacidosis during the year before a DTTP. Main outcome measures were GHb, severe hypoglycemia, severe ketoacidosis, and hospitalization., Results: A total of 341 participants had three or more episodes of severe hypoglycemia the year before a DTTP. Mean baseline GHb was 7.4 vs. 7.2% after the DTTP, incidence of severe hypoglycemia was 6.1 vs. 1.4 events x patient(-1) x year(-1), and hospitalization was 8.6 vs. 3.9 days x patient(-1) x year(-1). In mixed-effects models taking effects of centers and diabetes duration into account, mean difference was -0.3% (95% CI -0.5 to -0.1%; P = 0.0006) for GHb and -4.7 events x patient(-1) x year(-1) (-5.4 to -4; P < 0.0001) for severe hypoglycemia. A total of 95 patients had two or more episodes of severe ketoacidosis. GHb was 9.4% at baseline versus 8.7% after DTTP; incidence of severe ketoacidosis was 3.3 vs. 0.6 events x patient(-1) x year(-1), and hospitalization was 19.4 vs. 10.2 days x patient(-1) x year(-1). In linear models with diabetes duration as the fixed effect, the adjusted mean difference was -2.7 events x patient(-1) x year(-1) (95% CI -3.3 to -2.1; P < 0.0001) for severe ketoacidosis and -8.1 days (-12.9 to -3.2; P = 0.0014) for hospitalization., Conclusions: Patients at high risk for severe hypoglycemia or severe ketoacidosis may benefit from participation in a standard DTTP for intensive insulin therapy and dietary freedom.

Aims/hypothesis: The aim of this study was to evaluate the implementation of a course teaching flexible, intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care., Methods: This is a continuous quality-assurance project involving hospital diabetes centres. Every third year each centre re-examines 50 consecutive patients (evaluation sample) 1 year after participation in the course. Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes (190 evaluation samples) were re-examined between 1992 and 2004. The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment. The main outcome measures were HbA1c and severe hypoglycaemia., Results: Mean baseline HbA1c was 8.1%, and had decreased to 7.3% at follow-up; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention. In mixed-effects models adjusted for effects of centres, age and diabetes duration, the mean difference was -0.7% (95% CI -0.9 to -0.6%, p<0.0001) for HbA1c and -0.21 events per patient per year (95% CI -0.32 to -0.11, p=0.0001) for severe hypoglycaemia, with similar results for evaluation samples, with a maximum of 10% of patients lost to follow-up. Before intervention, the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA1c, whereas the risk was comparable across the range of HbA1c values after intervention., Conclusions/interpretation: Implemented as part of a continuous quality-assurance programme the self-management programme is effective and safe in routine care. Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia.

Aims: To assess predictors of mortality and end-stage diabetic complications in patients with Type 1 diabetes mellitus on intensified insulin therapy., Methods: A cohort of 3,674 patients (insulin treatment before age 31) who had participated in a 5-day in-patient group treatment and teaching programme for intensification of insulin therapy between 9/1978 and 12/1994 were reassessed after 10 +/- 3 (mean +/- SD) years., Results: Vital status and data on blindness, amputations, and renal replacement therapy were documented for 97% patients; 7% patients had died, 1.3% had become blind, 2% had amputations and 4.6% started renal replacement therapy. Using the Cox proportional hazards model, the following risk factors of mortality as assessed at baseline were identified: nephropathy (at least macroproteinuria), hazard ratio 3.8 (95% confidence interval 2.6-5.6); smoking, 1.9 (1.4-2.6); diabetes duration, 1.5 (1.2-1.8) for a difference of 10 years; serum cholesterol, 1.1 (1.0-1.2) for a difference of 1 mmol/l; lower social status, 1.4 (1.1-1.8) for a difference of 1 out of 3 levels; age, 1.3 (1.1-1.6) for a difference of 10 years; male sex, 1.4 (1.1-1.9); systolic blood pressure, 1.1 (1-1.2) for a difference of 10 mmHg. For the combined endpoint - blindness or amputations or renal replacement therapy - predictors were: nephropathy, foot complications, HbA1c, smoking, cholesterol, systolic blood pressure, retinopathy, hypertension, and social status., Conclusion: In Type 1 diabetic patients who start intensified insulin therapy, nephropathy remains the strongest predictor of mortality and end-stage complications. Glycosylated haemoglobin is a risk factor of end-stage complications but not of mortality. Conventional risk factors comparable to the general population, particularly smoking become operative as predictors of both mortality and end-stage complications.

Objective: To study the prognosis of persons with type 1 diabetes in relation to the degree of nephropathy at initiation of intensified insulin therapy., Design: Ten years follow-up of a cohort of 3674 patients who had participated in a 5-day group treatment and teaching programme for intensification of insulin therapy between September 1978 and December 1994., Setting: Ten diabetes centres in Germany., Subjects: A total of 3674 patients (insulin treatment before age 31), age at baseline 27 +/- 10 years, with a diabetes duration of 11 +/- 9 years. Patients were divided into three groups according to baseline renal parameters (group I, normal proteinuria, n = 1829; group II, microproteinuria, n = 1257; group III, at least macroproteinuria, n = 367)., Main Outcome Measures: End-stage diabetic complications (blindness, amputations, renal replacement therapy, standardized mortality ratios (SMR) and causes of death., Results: Outcome measures were documented for 97% of patients; 251 (7%) had died. During follow-up, 1% of patients in group I, 4% in group II and 47% in group III had at least one end-stage diabetic complication. SMR for men: nephropathy group I, 2.2 (95% CI = 1.5-3); group II, 3.2 (2.3-4.3); group III, 11.5 (8.8-14.7). SMR for women: group I, 2.5 (1.5-3.8); group II, 3.5 (2.2-5.3); group III, 27 (19.8-35.9). Causes of death for men and women combined: group I (total 58 deaths)--cardiovascular, 21 (36%); hypoglycaemia, 1; ketoacidosis, 3; violent deaths, 17 (29%); others, 16; group II (66 deaths)--cardiovascular, 25 (38%); hypoglycaemia, 2; ketoacidosis, 2; violent deaths, 14 (21%); others, 23; group III (114 deaths)--cardiovascular, 68 (60%); hypoglycaemia, 2; ketoacidosis, 5; infections, 15 (13%); violent deaths, 5 (4%); others, 19., Conclusions: Patients with microproteinuria have only a slightly worse prognosis than patients with normal proteinuria during the first 10 years after initiation of intensified insulin therapy. Excess mortality amongst patients who started intensified insulin therapy is mainly due to those with manifest clinical nephropathy.

Before any treatment of type 2 diabetes in accordance with the principles of evidence-based medicine can be generally recommended, the considerable disease heterogeneity must be taken into account, and randomized controlled intervention trials directed to cardiovascular and microangiopathic organ damage end points must be performed for the various subgroups of patients. Until then, it appears prudent to treat the typical Caucasian type 2 diabetic patient primarily by nondrug therapies, and if they fail to achieve the patient's individual treatment goals, then insulin treatment should be initiated. Treatment of type 2 diabetic patients with insulin alone, aimed at the patient's individual therapeutic goals, is effective and safe when conducted as an integral part of specific and structured treatment and teaching programs. Insulin treatment can be safely used to achieve near-normal HbA1c levels (< 7.0-7.5%) if prevention of diabetic microangiopathy is indicated, or to maintain HbA1c levels < 8.5-9.0% if catabolic symptoms due to insulin deficiency are to be prevented.

The diabetic foot syndrome has a strong impact on the morbidity of elderly patients with type 2 diabetes, since diabetics have a 22-fold higher amputation rate. The aim of this study was to conduct a prospective evaluation of elderly insulin-treated patients with type 2 diabetes, giving special consideration to the diabetic foot syndrome. 94 consecutively admitted patients (mean age 68 years; mean diabetes duration 13 years) were re-evaluated 2, 5 and 10 years after participation in a 5-day insulin treatment and teaching programme for patients with type 2 diabetes. During the 10-year follow-up period 60 (64%) patients had died. Of the remaining 34 patients 33 were evaluated personally or by phone. All patients still alive had no acute foot complications and no amputations during the 10-year follow-up period. In these patients an acceptable level of metabolic control and acute metabolic decompensations was found. However, in 55 deceased patients (no data were available for 5 patients) 20 above-knee amputations (1 patient on both legs) and 2 fore-foot amputations were performed. This shows that severe complications as amputations associated with high mortality will be grossly underestimated, unless deceased patients are included in follow-up studies. An improved care for the feet of elderly insulin-treated patients is needed.

The objective of this study was to identify possible risk factors of severe hypoglycaemia (SH) in a prospective population based study of adult Type I (insulin-dependent) diabetic patients. A representative sample of 684 patients (41% women, mean +/- SD age 36 +/- 11, diabetes duration 18 +/- 11 years), living in the district of Northrhine (9.5 million inhabitants), Germany, were examined in their homes using a mobile ambulance. A comprehensive baseline assessment of possible predictors of SH included sociodemographic and disease related variables, hypoglycaemia awareness, diabetes management, and attitudes and behavioural aspects as expressed by the patients. After a mean of 19 +/- 6 months 669 (98%) patients were interviewed about events of SH since the baseline examination. Using the multiple Cox proportional hazards model, five risk factors of SH were identified: SH during the preceding year [hazard ratio (HR) 2.7, 95% confidence intervals (CI) 1.8-4.2], any history of SH (HR 1.9, CI 1.1-3.4), C-peptide negativity (HR 4.0, CI 1.2-12.7), social status (HR 0.8 for a difference of 5 units for a value range of 0-24, CI 0.6-0.9), and patients' determination to reach normoglycaemia (HR 0.7 for a difference of 1 unit for a value range of 1-6, CI 0.5-0.9), indicating that the lower the social status and the higher the patients' determination to reach normoglycaemia, the higher the risk of SH. After eliminating the history of hypoglycaemia from the model, impaired hypoglycaemia awareness and patients' inappropriate denial of SH as their particular problem became additional significant risk factors of SH. In conclusion, in this population based study of adult Type I diabetic patients, C-peptide negativity, a previous event of SH, patients' determination to reach normoglycaemia and social class were risk factors of SH.

The objectives of the present analyses were to assess the association between HbA1c levels and severe hypoglycaemia (SH, treatment with glucose i.v. or glucagon injection) and to identify predictors of SH in a prospective multicentre trial. The study population consisted of 636 insulin-dependent diabetic patients who had participated in a structured 5-day in-patient group treatment and teaching programme for intensification of insulin therapy (ITTP) in one of 10 hospitals and who were re-examined after 1, 2, 3, and 6 years including assessment of demographic, disease and treatment related parameters, diabetes-related knowledge, behaviour, and emotional coping. At baseline, age (mean +/- SD) was 27 +/- 7 years, diabetes duration 9 +/- 7 years and HbA1c 8.3 +/- 1.9 %. During the 6-year follow-up, the mean HbA1c value improved to 7.6%, and in patients with a diabetes duration of more than 1 year at entry into the study (n = 538) the incidence of SH decreased from 0.28 cases/patient/year during the year preceding the ITTP to 0.17 cases/patient/year. The patient group was divided into decile groups according to mean follow-up HbA1c values. In each group more than 230 patient years could be analysed. Groups with mean HbA1c values of 5.7, 7.0, 7.4, 7.7 and 8.9% had comparable risks of SH (0.15-0.19 cases/patient/year). In a logistic regression analysis, mean HbA1c during follow-up, a history of SH during the year preceding the ITTP, C-peptide level, emotional coping, carrying emergency carbohydrates (as assessed at the 1-year follow-up), and age at onset of diabetes were significant independent predictors of SH. The incidence of SH between centres varied between 0.05 and 0.27 cases/patient/year. In conclusion, in the present analyses no linear or exponential relationship between HbA1c and severe hypoglycaemia could be identified by using simple group comparisons. Applying complex regression analyses, various patient-related predictors of severe hypoglycaemia were identified.

The Diabetes Education Study Group (DESG) of the European Association for the Study of Diabetes (EASD) was founded in 1979 with its major goal to make effective patient training an integral part of any diabetes therapy. Within the DESG, a number of models for structured diabetes treatment and teaching programmes were developed. Concerning the care of persons with Type 1 diabetes, substantial emphasis was placed upon the 5-day in-patient treatment and teaching programme for groups of 6 to 10 patients as originally introduced at the University of Geneva and further developed for general use at the University of Düsseldorf. During the early 1980s, this programme was based upon intensified insulin therapy including a stepwise liberalization of previously rigid rules for nutrition and life schedules. In several European centres the programme was continuously evaluated and shown to be effective as documented by significant reductions of glycated haemoglobin values, episodes of ketoacidosis, hospitalizations, and sick-day leaves. In contrast to the Diabetes Control and Complications Trial (DCCT) the improvement of glycated haemoglobin values was not associated with an increased risk of severe hypoglycaemia. Possible reasons for this favourable outcome are discussed. During recent years the 5-day treatment and teaching programme for Type 1 diabetes has been translated into the general health care system of Germany without any loss of its efficacy. In addition, in various other European countries, model centres of diabetes care have implemented the 5-day programme, and for a number of these centres, its efficacy to improve the overall quality of diabetes care has been published or presented at meetings.

The aim of the study was to identify predictors of long-term glycaemic control in Type 1 diabetic patients after participation in an intensified insulin treatment and teaching programme. The study population consisted of 697 Type 1 diabetic patients (mean age 26 +/- 7 (SD) years, duration of diabetes 8 +/- 7 years) who participated in the same structured intensified insulin treatment and teaching programme in 10 hospitals and who were re-examined after 1, 2, and 3 years. Multiple and logistic regression analyses were performed including a set of demographic, disease-related, social, and psychosocial variables as potential predictors. As dependent variables the average HbA1 values during the 3-year follow-up period and a composite variable (average HbA1 values/frequency of severe hypoglycaemia)--dividing patients into three groups with good, moderate or poor metabolic control--were considered. Regression analysis of average HbA1 values revealed significance (p < 0.05) for seven independent predictors in descending order: smoking, age at onset of diabetes, frequency of home blood glucose monitoring, socioeconomic status, diabetes-related knowledge, perceived coping abilities, and sex (R2 (percentage of variation explained by the model) = 17%). In a second regression model, HbA1 values before the intervention programme were added to the model and achieved the highest standardized regression coefficient (0.38), increasing R2 to 29%. In the logistic regression models considering both HbA1 and severe hypoglycaemia as a composite dependent variable, diabetes-related knowledge, HbA1 values before the intervention, smoking, perceived coping abilities, age at onset of diabetes, and C-peptide levels were the strongest predictors of glycaemic control. In conclusion, the relationship between demographic, disease-related, psychosocial, and social variables and metabolic control is complex. Therefore, simplistic concepts of linear causality should be abandoned. In addition to HbA1 values before the intervention, smoking, diabetes-related knowledge, home blood glucose monitoring, age at onset of diabetes, perceived coping abilities and C-peptide levels were the most significant and consistent predictors of glycaemic control.

The Diabetes Education Study Group of the European Diabetes Association was founded in 1979 with its major goal to make effective patient training an integral part of any diabetes therapy. However, even today, in many places diabetes education is not an obligatory part of treatment, but is regarded as an optional service to the patient which is frequently fragmentary and haphazard. On the other hand, many physicians still subject their patients to rigid dietary instructions and obedience training, an approach which is mistaken for diabetes education. Several misconceptions about diabetes education keep counteracting the spread and hence the availability of effective treatment and teaching programmes for all Type 1 diabetic patients. One such misconception is that diabetes education could compensate for deficiencies of inappropriate insulin treatment regimens. Studies failing to demonstrate the impact of diabetes education on metabolic control, typically used an insulin treatment regimen with only one or two insulin injections per day, the predominant use of intermediate acting insulin preparations, and without (day-to-day) adjustment of insulin dosages by the patients themselves. A further reason for a lack of success of diabetes education is an unstructured approach which is frequently mistaken for individualized care. The deleterious effects of putting patients on intensified insulin therapy without offering them sufficient and systematic training have manifested themselves at various places by an excessive increase in the risk of severe hypoglycaemia, and of ketoacidosis during therapy with continuous subcutaneous insulin infusion. The effective and safe performance of insulin therapy requires both a rational system of insulin substitution and intensive training of the patients to carry it out. The injection of regular insulin before main meals and the use of intermediate or long-acting insulin preparations for the substitution of basal insulin requirements combined with daily metabolic self-monitoring and (day-to-day) adaptation of insulin dosages by the patients themselves allow a substantial improvement of glycaemic control without an increase in the risk of severe hypoglycaemia and the adoption of a more flexible life style largely freed from forcing and directive dietary and other impositions. Each diabetes centre should continuously evaluate the quality of care offered to their patients as a basis for a specific and systematic improvement of its treatment and education programmes. Such quality control measures must include a recording of the patients' degree of metabolic control and the frequencies of severe hypoglycaemia and ketoacidosis.(ABSTRACT TRUNCATED AT 400 WORDS)

Up to now all published experience with intensified insulin therapy has originated from specialized diabetes centres. However, even in diabetes centres and under research conditions intensification of insulin therapy may substantially increase the risk of severe hypoglycaemia. The aim of the present study was to demonstrate the feasibility of effectively and safely transferring intensified insulin therapy based upon a 5-day in-patient treatment and teaching programme from a University diabetes centre to non-specialized general hospitals. A total of nine general hospitals were recruited; the University diabetes centre served as a reference centre. From each general hospital a nurse and a dietitian were trained as diabetes educators, and a diabetes unit with about 10 beds was organized within each department of internal medicine. A total of 697 consecutively admitted Type 1 (insulin-dependent) diabetic patients (age 26 +/- 7 years, duration of diabetes 8 +/- 7 years) who participated in the programme either in one of the general hospitals (n = 579) or in the reference centre (n = 118) were re-examined after 1, 2 and 3 years. Insulin therapy was intensified to a similar extent in the reference centre and the general hospitals; at the 3-year follow-up about 80% of the patients injected insulin at least three times daily or used continuous subcutaneous insulin infusion (10%), and about 70% reported measuring blood glucose levels more than twice per day. HbA1 levels were lowered (p < 0.0001) to comparable levels, i.e. from 10.6% (reference centre) and 9.9% (general hospital), respectively, at baseline to 9.4% and 9.3%, respectively, at the 3-year follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Objectives: To compare hypoglycemic warning symptoms (main objective) and incidence of severe hypoglycemia (secondary objective) between patients treated with animal and human insulin preparations., Research Design and Methods: Two hundred forty-seven patients on treatment with animal insulin preparations and 276 patients on human insulins, matched for duration of diabetes (16 +/- 11 vs. 15 +/- 10 yr), were recruited for the study. Patients were interviewed with a standardized questionnaire., Results: When asked which symptom usually occurs first during hypoglycemia, 19% of the animal insulin group and 22% of the human insulin group answered "sweating," 19 and 17%, respectively, answered "trembling," and 15 and 11%, respectively, answered "unrest." According to the patients' perception, in both groups, their most reliable hypoglycemic warning symptoms were "trembling" (26 and 22%) and "sweating" (15 and 18%). Six and eight percent of patients, respectively, reported hypoglycemia unawareness and 17 and 18%, respectively, impaired awareness of hypoglycemia. The incidence of severe hypoglycemia was 0.45 cases/patient-yr in patients treated with animal insulins and 0.46 cases/patient-yr in patients treated with human insulin preparations. The differences were not statistically significant., Conclusions: This study shows that hypoglycemic warning symptoms and the incidence of severe hypoglycemia are comparable between patients on treatment with human and animal insulin preparations.

It has been questioned whether aiming at near-normoglycaemia by intensified insulin treatment regimens is feasible and safe for the majority of patients with insulin-dependent diabetes. In this study, intensified insulin injection therapy (including blood glucose self-monitoring and multiple insulin injections) based upon a 5-day inpatient group teaching programme was evaluated in Type 1 (insulin-dependent) diabetes mellitus in the centralised health care system of Bucharest. One hundred patients (group A, initial HbA1 12.5%) were followed for 1 year on their standard therapy (individual teaching, no metabolic self-monitoring), and thereafter for 1 year on intensified therapy. Another 100 patients (group B, HbA1 12.3%) were followed for 2 years on intensified therapy. A third 100 patients (group C, HbA1 11.7%) were assigned to a basic 4-day inpatient group teaching programme with conventional insulin therapy (including self-monitoring of glucosuria and acetonuria) and followed for 1 year. Mean HbA1 remained unchanged after standard treatment (group A: 12.8% at 12 months), but decreased during intensified therapy (group A: 10.1% at 24 months; group B: 9.3% at 12 months, 9.5% at 24 months; p less than 0.0001). In group C, no change was found compared to standard treatment (i.e. group A at 12 months). Incidence rates of ketoacidosis were 0.16 episodes per patient per year during standard treatment, 0.01 during intensified treatment (p less than 0.01) and 0.04 in group C (p less than 0.025). Hospitalisation rates were reduced by 60% during intensified therapy and by 40% in group C. Frequency of severe hypoglycaemia was not significantly different between the three treatment regimens. Thus, under the condition that insulin treatment is based upon a structured and comprehensive training of the patient, intensified insulin injection therapy performed as routine treatment of Type 1 diabetes significantly lowers HbA1 levels without increasing the risk of severe hypoglycaemia.