[Effect of systematic information about psychosocial support services during outpatient radiotherapy. A controlled trial]. / Effekte systematischer Informationen über psychosoziale Angebote während der ambulanten Strahlentherapie. Eine kontrollierte Studie.

BACKGROUND: Up to 50 % of all cancer patients require psychosocial support during the course of their disease. However, only a proportion of these patients make use of the existing services. This is partly because patients are unaware that psychosocial support services are available to them. We investigated whether systematically providing printed information concerning psychosocial support can increase the knowledge and usage of these services, as well as health-related self-efficacy. MATERIALS AND METHODS: In a controlled trial, 108 breast cancer patients were assigned alternately to either an intervention- or a control group. At two predefined time points before and during radiotherapy, patients in the intervention group received correspondence informing them about psychosocial services (psycho-oncology, clinical social work and the Cancer Information Service).The control group received no systematic information. Using a standardized questionnaire, all patients were subsequently questioned about their knowledge of psychosocial support services, their perceived self-efficacy and their use of psychosocial support services. RESULTS: We found that systematic provision of information had a positive effect on the knowledge of psychosocial support services (p = 0.042; d = 0.45) and self-efficacy (p = 0.047; d = 0.42). However, no increase in the actual usage of these services was observed (p = 0.661; d = 0.10). CONCLUSION: The systematic provision of information in the form of written correspondence can easily be implemented into clinical routine and is an effective way to increase cancer patients' knowledge of psychosocial support services. Furthermore, providing information about the services had a positive impact on patients' perceived self-efficacy. However, simply making this information available did not increase the usage of psychosocial support services.

Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with Type 2 diabetes previously on long-term conventional insulin therapy: the SWITCH Pilot Study.

BACKGROUND: Addition of the long-acting basal human insulin analogue insulin glargine (LANTUS) to the treatment regimen of patients with inadequate glycaemic control on oral antidiabetic drugs (OADs) alone has previously been evaluated as effective, safe and convenient. This pilot study aimed to establish whether insulin glargine plus OADs is effective in Type 2 diabetes patients previously poorly controlled on premixed insulin therapy. METHODS: In an open, controlled, randomized, parallel-group, single-centre, 16-week pilot study, 52 patients (age 65.6+/-9.2 years; diabetes duration 15.3+/-7.6 years; insulin therapy duration 4.2+/-1.7 years, body mass index 31.4+/-2.9 kg/m(2)) with Type 2 diabetes (HbA (1c)> or =8.0%) on premixed human insulin (75/25 or 70/30) were randomized to once-daily morning insulin glargine plus glimepiride (Group A; n=17), insulin glargine plus glimepiride and metformin (Group B; n=18) or premixed insulin (Group C; n=17). Glycaemic control and incidence of hypoglycaemia were evaluated. RESULTS: HbA (1c) decreased significantly from baseline in Groups A and B, but not in Group C; (Group A: 7.87+/-0.66%, -0.35%, p=0.013; Group B: 7.44+/-0.92%, -0.69%, p=0.0057; Group C: 7.83+/-1.13%, -0.25%, p=0.32). There were no between-treatment differences at endpoint in HbA (1c), fasting blood glucose, mean daily blood glucose or symptomatic hypoglycaemia (mean events/patient: Group A, 2.2; Group B, 2.3; Group C, 2.0). At endpoint, 88% of patients in Group A, 81% in Group B and 94% in Group C opted to continue with their assigned regimen. CONCLUSIONS: This pilot study is the first prospective study to show that switching from premixed insulin to insulin glargine plus OAD treatment resulted in similar glycaemic control and treatment satisfaction. The results support the need for prospective examination in a larger-scale clinical study in patients with long-standing Type 2 diabetes and sub-optimal glycaemic control previously using a conventional premixed insulin regimen.

Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the Switch pilot study.

BACKGROUND: Addition of the long-acting basal human insulin analogue insulin glargine (LANTUS) to the treatment regimen of patients with inadequate glycaemic control on oral antidiabetic drugs (OADs) alone has previously been evaluated as effective, safe and convenient. This pilot study aimed to establish whether insulin glargine plus OADs is effective in Type 2 diabetes patients previously poorly controlled on premixed insulin therapy. METHODS: In an open, controlled, randomized, parallel-group, single-centre, 16-week pilot study, 52 patients (age 65.6+/-9.2 years; diabetes duration 15.3+/-7.6 years; insulin therapy duration 4.2+/-1.7 years, body mass index 31.4+/-2.9 kg/m2) with Type 2 diabetes (HbA1c>or=8.0%) on premixed human insulin (75/25 or 70/30) were randomized to once-daily morning insulin glargine plus glimepiride (Group A; n=17), insulin glargine plus glimepiride and metformin (Group B; n=18) or premixed insulin (Group C; n=17). Glycaemic control and incidence of hypoglycaemia were evaluated. RESULTS: HbA1c decreased significantly from baseline in Groups A and B, but not in Group C; (Group A: 7.87+/-0.66%, -0.35%, p=0.013; Group B: 7.44+/-0.92%, -0.69%, p=0.0057; Group C: 7.83+/-1.13%, -0.25%, p=0.32). There were no between-treatment differences at endpoint in HbA1c, fasting blood glucose, mean daily blood glucose or symptomatic hypoglycaemia (mean events/patient: Group A, 2.2; Group B, 2.3; Group C, 2.0). At endpoint, 88% of patients in Group A, 81% in Group B and 94% in Group C opted to continue with their assigned regimen. CONCLUSIONS: This pilot study is the first prospective study to show that switching from premixed insulin to insulin glargine plus OAD treatment resulted in similar glycaemic control and treatment satisfaction. The results support the need for prospective examination in a larger-scale clinical study in patients with long-standing Type 2 diabetes and sub-optimal glycaemic control previously using a conventional premixed insulin regimen.

Changes in Quality of Diabetes Care and Morbidity over 20 Years in People with Type 1 Diabetes and Long Diabetes Duration: The JEVIN Trial.

Background: The JEVIN trial started as a cross-sectional study in 1989/90 in Jena, a city of the former German Democratic Republic. At that time, the centralized diabetes care system was broken down and restarted 10 years later; structured treatment and teaching programs were implemented, blood glucose self-monitoring, insulin pump-systems and analogue insulin were introduced. We surveyed people with type-1-diabetes of the baseline JEVIN trial in a 20-year follow-up. Methods: 131 patients with type-1-diabetes were analyzed in 1989/90. Of the living population in 2009/10 (n=104), 83 persons were identified and 75 persons with a mean diabetes duration of 35 years were reexamined regarding HbA1c, self-monitoring, diabetes therapy, severe hypoglycemia, diabetic late complications and compared with the results of the same persons in 1989/90. Results: HbA1c decreased from 57.1 mmol/mol in 1989/90 to 52.7 mmol/mol in 2009/10 (7.4 -7.0%; p=0.049). Self-monitoring of blood glucose increased from 2 to 35 tests/week (p<0.001). 100%-use of animal insulin changed to human and analogue insulin therapy. The incidence of severe hypoglycemia increased from 0.1 to 0.16/patient-year. Retinopathy increased from 29 to 69% (p<0.001), nephropathy from 5 to 27% (p<0.001) and neuropathy from 13 to 43% (p<0.001). 17% had no diabetic late complications. Conclusions: The JEVIN trial shows a significant improve in HbA1c in the past 20 years. Severe hypoglycemia occurred rarely and 17% were still free of any diabetic late complication after 35 years of diabetes. This indicates a good quality of diabetes care in a German setting.

Structured diabetes therapy and education improves the outcome of patients with insulin treated diabetes mellitus. The 10 year follow-up of a prospective, population-based survey on the quality of diabetes care (the JEVIN Trial).

AIMS/HYPOTHESIS: JEVIN (Jena's St. Vincent Trial) is a prospective, 10 year follow-up, population-based survey of all insulin treated patients with type 1 and type 2 diabetes mellitus aged 16 to 60 years and living in the city of Jena (100,000 inhabitants), Thuringia, Germany. It aims to show the effects of implementation of the St. Vincent Declaration and to evaluate the effect of recent changes in the health care system and new treatment strategies. PATIENTS AND METHODS: 190 patients (83% of the target population), 244 patients (90%) and 261 patients (90%) were studied in 1989/90, 1994/95 and 1999/2000, respectively. RESULTS: Up to 1994/95, the HbA1c of patients with type 1 diabetes mellitus increased (1994/95: 8.50+/-1.80% versus 1989/90: 7.83+/-1.60%, p=0.002). For patients with type 2 diabetes mellitus, it remained constant (9.01+/-2.06% versus 9.17+/-1.60%, n. s.). During the period from 1994/95 to 1999/2000, there was a substantial improvement in the relative HbA1c of both, patients with type 1 (7.62+/-1.55%, p<0.0001), and with type 2 diabetes (7.57+/-1.29%, p<0.0001). Up to 1999/2000, 87.7% of the patients with type 1 (1989/90: 0%, 1994/95: 73.2%) and 96.6% of the patients with type 2 diabetes (1989/90: 0%, 1994/95: 89.7%) participated in TTP's. The incidence of acute and the prevalence of long-term complications remained constant. CONCLUSIONS: Results of the population-based, prospective trial to optimise patients' quality of diabetic control suggest: For patients with insulin treated type 2 diabetes mellitus, excellent treatment can be available by primary care physicians interested, educated and highly engaged in diabetes therapy. Moreover, structured diabetes therapy consisting of treatment and teaching programmes, regular self-monitoring, patients' insulin dose adjustment and patients' empowerment, should be offered to all patients with diabetes mellitus.

Overweight, obesity and elevated blood pressure in children and adolescents.

OBJECTIVE: Since many years in adults associations between dyslipidaemia, increased insulin resistance, arterial hypertension and the risk for cardiovascular diseases have been recognized. It was the aim of the present trial to investigate these associations and interactions between height, weight, body-mass index and blood pressure values in overweight/obese and normal weight children and adolescents. PATIENTS AND METHODS: 172 children and adolescents (n = 86 with overweight and obesity, n = 86 controls) were studied. In all the subjects anthropometrical data and blood pressure values were assessed. RESULTS: Overweight and obese children had significantly higher blood pressure values (systolic 117.9 +/- 9.7, diastolic 75.6 +/- 8.8 mmHg) than control subjects (systolic 111.4 +/- 11.0, diastolic 69.5 +/- 8.8 mmHg, p<0.001/0.001). Additionally in overweight and obese subjects the number of patients with blood pressure values below the 50th percentile was lower, but the numbers of children and adolescents with values >or=50th age-, height- and gender-specific percentiles were significantly higher. In multivariate analysis of overweight/obese children and adolescents only patients' BMI (R-square = 0.26, beta = 0.52, p<0.001), but not sex, age, height or weight revealed any association with systolic blood pressure values. Diastolic blood pressure revealed an association with childrens' and adolescents' weight (R-square = 0.22, beta = 0.48, p<0.001), but there were no associations with body-mass index, sex, age or height. In normal weight control subjects age (beta = 0.32, p = 0.01) and height (beta = 0.28, p = 0.03) showed associations with the systolic blood pressure values (R-square = 0.15), but only childrens' and adolescents' height (beta = 0.39, p<0.001) was associated with diastolic blood pressure (R-square = 0.28). CONCLUSIONS: Overweight and obesity in childhood are highly associated with multiple comorbidities, elevated blood pressure values, dyslipidaemia, reduced insulin sensitivity and alterations of large and minor vessels. Overweight and obesity in children and adolescents should not longer be regarded as variations of normality, but as diseases with an extremely high risk for the development of atherosclerosis and cardiovascular complications in adulthood. Knowledge of these complex associations implicate even in young age the need for intervention.

Diabetes, insulin, and risk of cancer.

Up to now, the studies involving diabetes mellitus and malignancies show controversial results: Many of them have found incidences of malignancies that were comparable or even lower than those in nondiabetic subjects; others conclude that diabetes mellitus is linked to a higher incidence of malignancies and/or a predictor of mortality from cancer. Insulin and its precursors, pro- and pre-proinsulin, have been shown to have some homology to the insulin-like growth factors, but, moreover they have some affinity to bind at receptors of the tumor growth factor and some hybrids too. Hence, an association between diabetes mellitus, insulin, hyperinsulinaemia, and carcinogenesis appears plausible. On the other hand, diabetes mellitus can influence different hormone levels. In some tumor entities, such as prostate carcinoma, this effect can somewhat counterbalance the direct mitogene effect of insulin and its precursors. All in all, as a result of the complexity of these mechanisms and the differences between the tumor entities, the question whether diabetes mellitus is associated with an increased or a reduced risk for the development and in respect of the prognosis of cancer cannot be answered. The only way to give some answer is to focus on specific tumor entities: It seems that diabetes mellitus and/or hyperglycaemia are independent risk factors and/or predictors at least in respect of cancer of the colon, pancreas, female breast, endometrium, and, in men, of the liver and bladder. However, most of these data were assessed in patients with type 2 diabetes mellitus. This makes it highly questionable whether the data can easily be transferred to patients with type 1 diabetes. Moreover, additional potential limitations are that most of the studies do not focus on the treatment modality or the race of participants. In conclusion, up to the present, we have an increased risk for some and a reduced risk for other tumor entities, but still, we cannot give the general answer.

Use and Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Multiple Daily Insulin Injection Therapy (MIT) in Children, Adolescents and Young Adults with Type 1 Diabetes Mellitus.

UNLABELLED: Today continuous subcutaneous insulin infusion (CSII) is frequently used in children and adolescents with type 1 diabetes mellitus. The present cross-sectional trial aimed to document current practice, quality of diabetes control and incidence of acute complications in different age-groups under CSII vs. multiple daily insulin injection therapy (MIT). Moreover the survey analyzed socio-demographic backgrounds of the patients. PATIENTS AND METHODS: A total of 901 patients (age 11.5±4.0, diabetes duration 4.0±3.6 years) was entered in the database. Clinical data, laboratory parameters and, using a standardized questionnaire, socio-demographic data were assessed. For age-related analyses patients were allocated to 4 groups: pre-school children (< 6 years), pre-adolescents (≥ 6 and<11 years), adolescents (≥ 11 and<16 years) and young adults (≥ 16 and<22 years). RESULTS: Of the cohort n=194 had a CSII, n=707 had a MIT. Patients with CSII vs. MIT had a longer diabetes duration, they used more frequently insulin analogues, performed more frequently blood-glucose self-tests and had a lower insulin dosage per kilogram body weight. In respect of HbA1c, the mean amplitude of blood-glucose excursions, but also of lipids, creatinine, microalbuminuria and blood pressure, there were no differences in neither age-group between patients with CSII and MIT. In patients with CSII and MIT, there was a tendency (p<0.05) towards an increase in HbA1c in adolescents and young adults and there was a decrease (p<0.05 for tendency) in the frequency of hypoglycaemia from the age group of young adults to pre-school children. Adolescents and young adults with CSII had a higher educational level. Pre-adolescents, adolescents and young adults with CSII have also better diabetes-related knowledge. Moreover, in all age-groups, the parents of patients with CSII had mostly a lower unemployment rate and higher educational levels. CONCLUSIONS: The present analyses demonstrate that in all age-groups CSII provides convenient and flexible insulin delivery during routine treatment of type 1 diabetes. There is reasonable quality of diabetes control accompanied by a low incidence of hypoglycaemia and ketoacidosis. However, under CSII and MIT there is an increase of HbA1c towards adolescence. It must also highlighted that CSII seems to be expansive and that CSII is more frequently used in patients with better educational levels and deriving from higher social classes.

Malignancies in patients with insulin-treated diabetes mellitus.

In patients with diabetes mellitus, contradictory results have been reported indicating both increased and reduced risks of malignancies. In the present trial all insulin-treated diabetic patients (n = 2720) attending our centre since 1995 were studied. Of these patients, 28 (type 1/type 2: n = 1/27, 23 women) developed malignancies during insulin therapy: 11 patients developed cancer of the breast, 4 patients cancer of the pancreas, 3 patients cancer of the kidneys and 10 patients developed other malignancies. The characteristics of these patients [mean +/- SD (range)] were as follows: age 68.8 +/- 8.6 (52.0 87.0) years, diabetes duration 13.1 +/- 8.1 (0.5-29.0) years, duration of insulin therapy at the time of the diagnosis of malignancy 4.3 +/- 5.7 (0.5 24.0) years, insulin dosage 0.67 +/- 0.43 (0.11-1.72) IU/kg body weight, mean HbAlc 9.6 +/- 1.9 (6.8-14.9)% (HPLC, Diamat, normal range 4.4%-5.9%). The prevalences of nephropathy, retinopathy (non-proliferative: n = 7) and peripheral neuropathy were 35.7%, 25.0% and 46.4% respectively. When the features of the 27 patients with type 2 diabetes were compared with the characteristics of the type 2 diabetic patients (n = 117, 63 women) studied in a population-based survey of insulin-treated diabetic patients, also performed in the area of Jena [JEVIN; Schiel R et al. (1997a)] there were no significant differences in the duration of insulin therapy (JEVIN: 4.7 +/- 4.3 years, P = 0.64), insulin dosage (JEVIN: 0.55 +/- 0.27 IU/kg body weight, P = 0.08), mean HbAlc (JEVIN: 9.0 +/- 2.1%, P = 0.16) and the prevalences of long-term complications of diabetes. The quality of diabetes control in insulin-treated patients suffering from malignancies is comparable to that of a selection-free population of diabetic patients. Furthermore, in comparison to non-diabetic subjects our diabetic patients showed no altered risk for malignancies as a function of insulin dosage, the duration of diabetes or insulin therapy, the quality of diabetes control or the prevalence of long-term complications of the disease.

Quality of diabetes care, diabetes knowledge and risk of severe hypoglycaemia one and four years after participation in a 5-day structured treatment and teaching programme for intensified insulin therapy.

Intensification of insulin therapy in the Diabetes Control and Complications Trial led to an improvement in the quality of diabetes care, which was accompanied, however, by a threefold increase in the risk of severe hypoglycaemia. The present trial, a long-term evaluation of a structured 5-day treatment and teaching programme (DTTP) for intensified insulin therapy, was performed to clarify factors determining HbA1c, the incidence of severe hypoglycaemia, diabetes knowledge and quality of life. Ninety-four Type 1 diabetic patients were examined at baseline and 4 years after participation in a DTTP. Comparison of baseline data with measurements at the 4-year follow-up examination showed that relative HbA1c (= HbA1c/mean normal) improved (1.9 +/- 0.51 vs 1.55 +/- 0.3*, p < 0.001, *excluding 4 patients with diabetes manifestation at baseline) and that frequencies of daily insulin injections (3.73 +/- 1.23 vs 4.9 +/- 0.69*, p < 0.001) and weekly blood glucose self-tests (6.6 +/- 10.1 vs 25.5 +/- 8.7*, p < 0.001) increased, whereas the incidence of severe hypoglycaemia (intravenous glucose, glucagon injection) remained stable (0.19 vs 0.24, p = 0.48). Patients with less diabetes knowledge had higher HbA1c levels and a higher incidence of severe hypoglycaemia. In the group of patients with severe hypoglycaemia, certain crucial gaps in diabetes knowledge were identified concerning the effects of physical activity, nutrition and long-term complications of diabetes. In multivariate analysis. The most important factor associated with HbA1c was diabetes knowledge which, however, was not influenced by educational level or other factors. Interventions, such as the identification of psychosocial factors which may interact with diabetes knowledge, quality of life and successful self-management of diabetes by patients, are needed to improve the efficacy of DTTPs and to prevent severe side effects such as hypoglycaemia.

Blood-glucose self-monitoring in insulin treated type 2 diabetes mellitus a cross-sectional study with an intervention group.

Up to the present there is controversy about blood-glucose self-monitoring in type 2 diabetes. In 842 insulin-treated type 2 diabetic patients (age 60.1 +/- 10.9, diabetes duration since diagnosis 12.6 +/- 7.6 years, relative HbA1c 1.83 +/- 0.39% [relative HbA1c = HbA1c/mean normal, HPLC, Diamat]) a cross-sectional study was conducted to assess blood-glucose self-monitoring and interactions with quality of diabetes care. There was a negative correlation (r = -0.17, p < 0.001) between the frequency of blood-glucose self-tests/week and HbA1c. Performing multivariate analysis the most important parameters associated with HbA1c (R-square = 0.10) were: The frequency of blood-glucose self-tests/week (c = -0.005, p < 0.001), the insulin-dosage/kg body weight (c = 0.001, p = 0.0032) and the participation in a 5-day structured treatment and teaching programme for patients with conventional insulin therapy (5-TTP, c = 0.085, p < 0.0001). Other factors investigated in the model (age, diabetes duration, number of insulin injections/day, sex) showed no associations. Performing a sub-group analysis in patients older than 60 years (n = 396) parameters associated with HbA1c (R-square = 0.16) were the participation in a 5-TTP (c = 0.09, p = 0.002) and the frequency of blood-glucose self-tests/week (c = -0.006, p = 0.0018) too. In an further subgroup analysis patients (n = 249) were investigated who have not participated in a 5-TTP. In this cohort there were no correlations and no associations between the frequency of blood-glucose self-monitoring and HbA1c. Then, an intervention was started: 33 out of the 249 patients participated in a 5-TTP. At the time of re-examination 1 year after participating in the 5-TTP, the relative HbA1c decreased from 1.84 +/- 0.38% to 1.61 +/- 0.30% (p = 0.007) and there was a strong association between the frequency of blood-glucose self-tests/week and HbA1c (c = -0.016, p = 0.0032, R-square = 0.25). Daily blood-glucose self-monitoring was statistically associated with better quality of metabolic control. Participation in a 5-TTP and regularly blood-glucose self-monitoring is mandatory for all insulin-treated patients with type 2 diabetes mellitus.

Should insulin therapy in type 2 diabetic patients be started on an out- or inpatient basis? Results of a prospective controlled trial using the same treatment and teaching programme in ambulatory care and a university hospital.

The aim of this study was to determine whether Type 2 diabetic patients should be hospitalised to start insulin therapy. The same structured diabetes treatment and teaching programme (DTTP) was used in outpatients in 10 private practices after postgraduate training of physicians and teaching staff as well as in the Diabetes Department of the University Hospital of Jena, Germany. Seventy-two consecutive Type 2 diabetic patients (ambulatory group) participated in the outpatient DTTP. After one year, 70 patients were re-evaluated and compared with 70 other patients (matched pairs) who were referred to the University Hospital of Jena to start insulin treatment and participated in the same programme during hospitalisation. Initially there were no significant differences between the groups for age, gender, HbA1c, body mass index (BMI), and the time since diagnosis of diabetes. HbA1c (mean normal value 5%) decreased in both groups within the 12 months of follow-up (ambulatory group from 10.3 +/- 2.2 to 8.1 +/- 1.7, p < 0.0001; inpatient group from 10.4 +/- 1.6 to 8.4 +/- 1.7, P = 0.0001). At follow-up there were no significant differences between the groups concerning insulin dosage, HbA1c, severe hypoglycaemia, BMI, and hospitalisation. In combination with a DTTP, the initiation of insulin therapy on an ambulatory basis was as safe and effective as in the inpatient programme. Cost-benefit analysis demonstrated substantial savings in direct costs in the ambulatory programme.

GAD autoantibodies in a selection-free population of insulin-treated diabetic patients: indicator of a high prevalence of LADA?

UNLABELLED: Up to the present only few data have been available concerning the prevalence of diabetes-specific autoantibodies (anti-GAD, ICA, IAA, IA-2) in unselected populations, in particular in type 2 diabetic patients. Hence, the aim of the present study was to determine the prevalence of anti-GAD in a selection-free population of insulin-treated diabetic patients. Accordingly, 90% of all the insulin-treated diabetic patients (type 1, n=127, type 2, n=117) aged 16-60 years and living in the city of Jena (100242 inhabitants) were examined. In order to test sera for anti-GAD, serum samples were taken in 75% of type 1 (n=95) and in 80% of insulin-treated type 2 diabetic (n=94) patients. RESULTS: In the group of type 1 diabetic patients 55% of the patients tested were positive for anti-GAD. But, interestingly, in the type 2 group, a total of 21% patients were positive. With respect to this high percentage of anti-GAD positive type 2 diabetic patients it must be suggested that the frequency of patients with latent autoimmune diabetes mellitus in adults (LADA) was underestimated in the past.

Prevalence of sexual disorders in a selection-free diabetic population (JEVIN).

There is an extensive literature on sexual disorders among diabetic patients, but a shortage of studies on their prevalence in selection-free populations. In the present trial (JEVIN), 90% of all insulin-treated diabetic patients (IDDM/NIDDM, n = 127/117) aged 16-60 years and living in the city of Jena (100247 inhabitants) were studied. Each subject underwent a structured interview followed by a clinical and laboratory examination. The prevalence of sexual disorders was 32% in IDDM and 46% in NIDDM male patients. Patients with sexual disorders were older (IDDM 47.5 +/- 9.8 vs. 37.7 +/- 11.6, P = 0.0004; NIDDM 53.4 +/- 4.3 vs. 49.5 +/- 8.2 years, P = 0.04) and had longer diabetes duration (IDDM 23.1 +/- 13.8 vs. 13.5 +/- 11.1, P = 0.001; NIDDM 12.4 +/- 7.5 vs. 8.4 +/- 5.8 years, P = 0.03) than patients without sexual disorders. There were no significant differences (P < 0.05) between the groups as regards HbA1c, body-mass index and insulin dose/kg body weight. The prevalence of diabetes long-term complications in men with versus men without sexual disorders (IDDM/NIDDM): retinopathy, 65/53% vs. 50/18% (P = 0.34/0.03); neuropathy, 58/48% vs. 9/34% (P = 0.001/0.47); nephropathy, 65/50% vs. 12/36% (P = 0.001/0.45). In addition, all the patients completed standardized questionnaires according to Bradley et al. and Lewis et al. to assess quality of life and treatment satisfaction, and one question concerning sexual disorders. The quality of life of IDDM patients with sexual disorders was lower than that of patients without sexual disorders (42.2 +/- 11.4 vs. 54.2 +/- 8.5, P = 0.0005), but there were no differences (P < 0.05) in NIDDM patients. In women, the prevalence of sexual disorders was 18/42% in IDDM and NIDDM. Comparing these data with the literature and with reports from healthy controls, mostly there is clearly an underestimation of the prevalence of sexual disorders in diabetic populations. Physicians must make more efforts to detect and treat sexual disorders, which may result in an improvement of patients' quality of life.

Long-term efficacy of a 5-day structured teaching and treatment programme for intensified conventional insulin therapy and risk for severe hypoglycemia.

In the DCCT, intensification of insulin therapy led to a threefold increase in the risk of severe hypoglycemia (defined as the need for third party assistance). The reasons for this strong exponential relationship appears to be unclear to date. The present trial, a long-term evaluation of a 5-day structured teaching and treatment programme (5-DTTP) for intensified conventional insulin therapy (ICT), was performed to elucidate factors determining HbA1c and the incidence of severe hypoglycemia. A total of 71 patients were examined at baseline and 45.5 +/- 4.2 months following participation in a 5-DTTP. Comparing the data at follow-up examination with baseline measurements. HbA1c improved (8.52 +/- 2.29% vs. 8.0 +/- 1.43%, P = 0.04), the frequency of daily insulin injections (3.1 +/- 1.6 vs. 4.8 +/- 0.8, P < 0.001) and weekly blood-glucose self-tests (5.2 +/- 8.9 vs. 25.5 +/- 9.6, P < 0.001) increased, and the incidence of severe hypoglycemia (glucose i.v., glucagon injection) remained stable (0.18 vs. 0.17, P = 0.99). But, comparing the 21 patients who suffered from severe hypoglycemia during the follow-up period with the 50 patients without hypoglycemia, no differences between the two groups were found with respect to metabolic control (7.70 +/- 1.48% vs. 8.21 +/- 1.43%, P = 0.17), quality of life or treatment satisfaction. However differences arose with respect to diabetes knowledge. In the group of 21 patients with severe hypoglycemia we identified certain crucial gaps in diabetes knowledge: insulin self-adjustment; dietary aspects; hypo- and hyperglycemia. Performing multiple regression analysis, strong correlations were found between HbA1c and diabetes knowledge (r = -0.58. P = 0.002 for 50 patients without hypoglycemia and r = -0.63, P = 0.05 for 21 patients with hypoglycemia). In the total group, the most important factors determining HbA1c, were diabetes knowledge (r = -0.055, P = 0.007) and daily insulin dosage/kg body weight (r = 2.13, P = 0.0008, R2 = 0.26). Intervention like education of patients on a continuous basis and modifications of the DTTP's with more information and training in the recognition and treatment of hypoglycemic episodes seems to be essential to prevent hypoglycemia and to improve the efficacy of DTTP's over longer periods of time.

Screening for people with diabetes mellitus for poor blood glucose control in an ophthalmological laser clinic.

PURPOSE: The study was performed to test the effect of a structured intervention in diabetic patients with poor glycaemic control in an ophthalmological department. PATIENTS AND METHODS: All the patients attending the ophthalmological out-patient department with the need for laser therapy due to diabetic retinopathy were investigated from January to March 1998 (Type 1: n=20, Type 2: n=144). If an HbA(1c)-level higher than 9.0% was found the patient was informed within 1 week and a standardised letter was sent to the primary care physician and the local ophthalmologist. Over the first 3 months of 1999 the effect was evaluated. RESULTS: HbA(1c) values higher than 9.0% were found in eight/20 of the patients (40%) with Type 1 diabetes and in 61/144 of the patients (54%) with Type 2 diabetes. In 55% this new information in the context of the need for laser therapy resulted in the acceptance of a structured intervention by the patient. This led to an improvement of the HbA(1c) in the people with Type 1 diabetes. CONCLUSION: Patients with poor blood glucose control can be identified in an ophthalmological department. The need for laser therapy can be used to motivate the patients for a significant improvement of the quality of blood glucose control.

Intensive or conventional insulin therapy in type 2 diabetic patients? A population-based study on metabolic control and quality of life (The JEVIN-trial).

Long-term micro- and macrovascular complications cause major morbidity and mortality in patients with type 2 diabetes mellitus. Up to the present it is not clear whether intensified or conventional insulin treatment is more effective to keep blood glucose concentrations close to the normal range. In the present trial 90% (n = 117) of all insulin-treated type 2 diabetic patients aged 16 to 60 years and living in the city of Jena (100,247 inhabitants), Thuringia, Germany were examined. Fourty patients (34%) were on intensive insulin therapy (ICT, > or = 2 injections of normal- and > or = 1 injection of NPH-/mixed-insulin/day, > or = 1 insulin-dose adjustments/week, > or = 2 blood-glucose self-tests/day) and 77 patients (66%) were on conventional insulin therapy (CIT). Patients with ICT had more injections/d (4.3 +/- 0.7 vs CIT 2.4 +/- 0.7, p < 0.001), more insulin-dose adjustments/week < or = 11.5 +/- 8.2 vs 2.2 +/- 5.2, p < 0.001) and more blood-glucose self-tests/week (25.2 +/- 5.7 vs 9.6 +/- 8.8, p < 0.001). Patients with ICT had higher insulin doses (0.71 +/- 0.32 vs 0.47 +/- 0.2 IU/kg body wt/d, p < 0.001), were younger (50.5 +/-6.7 vs 54.0 +/- 5.9 years, p = 0.004) and they had a non-significant tendency to a better HbAlc (8.7 +/- 2.2 vs 9.2 +/- 2.0%, p = 0.23, HPLC, Diamat, normal range 4.4-5,9%). There was a negative correlation between HbAlc and the frequency of blood-glucose self-tests/week (r = -0.23, p = 0.019) and the number of insulin-dose adjustments/week (r = -0.33, p < 0.001). There were no differences between the groups as regards body-mass index (29.7 +/-4.9 vs 28.0 +/- 4.5 kg/m2, p = 0.06), diabetes duration (12.3 +/- 6.9 vs 12.2 +/- 7.5 years, p = 0.96), duration of insulin therapy (4.2 +/-3.5 versus 4.5 +/- 4.8 years, p = 0.67), incidence of acute complications (severe hypoglycaemia, diabetic coma), prevalence of retino-, nephro- and neuropathy (assessed according to Young et al.) and education or socio-economic factors. Also, in respect of quality of life and treatment satisfaction, assessed with standardized questionnaires according to Bradley et al. and Lewis et al., there were no differences between the two groups. In conclusion, in type 2 diabetic patients, ICT seems to be indicated in a second step in "problem-patients" with bad metabolic control under CIT and/or individual's need for more flexibility. Perhaps, in these patients ICT leads to an improvement in the quality of metabolic control.

Insulin pump therapy in patients with Type 1 diabetes mellitus: results of the Nationwide Quality Circle in Germany (ASD) 1999-2000.

BACKGROUND AND AIMS: Only a few specialised centres in Germany initiated insulin pump therapy before 1990. Initiation of pump therapy involves the participation in a structured treatment and teaching programme (TTP). During the last decade insulin pump therapy has been widely used. The impact of this decentralisation on the quality of care is still unknown. The aim of this trial was both to evaluate the outcome of insulin pump therapy outside specialised centres and to identify features that might be associated with persistently increased HbA1 c levels. PATIENTS AND METHODS: 250 patients with type 1 diabetes mellitus (age 36.0 +/- 13.1 years; diabetes duration 16.1 +/- 9.9 years), who were on continuous subcutaneous insulin infusion (CSII) therapy during 1999 - 2000, were individually included in the study. Second examination was performed one year after participation in the in-patient TTP for insulin pump therapy. Patients were recruited from 21 member institutions of the Working Group for Structured Diabetes Therapy of the German Diabetes Association. Further details were sought by questionnaire on those patients with persistently increased HbA1c (> 1.7 fold of mean normal range.) RESULTS: One year after participation in the TTP for CSII relative HbA1c (original value/mean normal of the local method [Müller et al., 1999]) decreased from 1.51 (0.9 - 3.2) to 1.44 (0.9 - 3.6) (p < 0.0001), severe hypoglycaemia from 0.46 to 0.12/patient/year (p < 0.001), severe ketoacidosis from 0.08 to 0.05/patients/year (p = 0.003) and hospitalisation from 5.2 to 3.1 days/patient/year (p = 0.002). In 43/207 (17%) the incidence of severe hypoglycaemia was unchanged (before 0.12 and after TTP 0.14/patients/year), there was slight increase in severe ketoacidosis (before 0.15; after TTP 0.23/patients/year) and hospitalisation days were unchanged (before 4.5; after TTP 4.4 days/patients/year). The following factors were associated with adverse outcomes: psychological problems including eating disorders and alcohol abuse (28%), lack of interest in self-management (28%) and social problems (11%). In 28% there was no follow-up treatment by diabetologists specialised in pump therapy. CONCLUSION: The benefits of insulin pump therapy are improvement of HbA1c, reduction of hypoglycaemia, ketoacidosis and hospitalisation days as well as improved flexibility. It is possible to draw up a list of clinical criteria and service requirements, which are likely to reduce failures.

Population-based measurement of quality of diabetes care using HbA1c values in the state of Thuringia/Germany.

INTRODUCTION/HYPOTHESIS: There remains insufficient knowledge about the quality of diabetes therapy regarding structure, process and outcome given by primary care in Thuringia, and elsewhere in Germany. The project assesses a means of determining the quality of diabetes therapy in primary care by analysis of HbA1c values within a broad territory. METHODS: HbA1c tests of Thuringian patients were analysed by 20 participating medical laboratories between January 1 and March 31, 2002; each HbA1c test was identified by the postal code of the Thuringian General Practitioner (GP) who ordered the test and adjusted by a standardisation procedure (mean normal of healthy subjects 5 %). The German state of Thuringia (population of 2,421,871) consists of 23 urban and rural districts. This format was also used in the present study. RESULTS: Twenty participating laboratories contributed 59,702 HbA1c tests from diabetic patients in Thuringia. Adjusted mean HbA1c of entire Thuringia: 6.75 %, 36.4 % of all HbA1c tests were above 7.0 % and 3,0 % of all HbA1c values above 10.0 %. Regional percentage of HbA1c tests above 7.0 % ranged between 28.2 % and 47.3 %. Regional percentage of HbA1c tests above 10.0 % ranged between 1.8 % and 4.8 %. Subgroup analyses comparing urban vs. rural districts showed significantly lower mean HbA1c (6.72 % vs. 6.75 %, CI 0.01 - 0.06, p < 0.01) and percentage of HbA1c tests above 7 % (8.19 % vs. 8.24 %, CI 0.01 - 0.08, p < 0.01) in urban areas. CONCLUSIONS: Mean HbA1c as an indicator of glycaemic control of diabetes patients in primary care in Thuringia was good. The percentage of patients who need immediate medical intervention to prevent acute complications varied between districts, which is indicative for differences in quality of diabetes care in Thuringia. However, the proposed method is still experimental and has not yet been evaluated. Consequently, considerable bias might influence the results.

Effect of smoking on risk factors for cardiovascular disease in patients with diabetes mellitus and renal insufficiency.

BACKGROUND: Many studies have been published demonstrating a strong correlation between smoking, renal lesions and cardiovascular morbidity and mortality. Possible contributing factors are elevated blood pressure values, changes in vascular reactivity, concentrations of lipids, fibrinogen and carboxyhemoglobin, in patients with diabetes mellitus, the quality of diabetes control and insulin resistance. Other possible risk factors may include advanced glycation end (AGE)-products, total plasma homocysteine and metabolites as well as symmetrical (SDMA) and asymmetrical (ADMA) dimethylarginine. It was the goal of the present trial to investigate the serum concentrations of these >new<, possible risk factors in a selection free population of patients with type 1 and insulin-treated type 2 diabetes mellitus, in patients with chronic renal insufficiency and in renal transplant recipients. The second aim was to analyse the effect of cigarette smoking on the levels of these laboratory parameters. PATIENTS AND METHODS: A total of 544 subjects (n = 98 patients with chronic renal insufficiency without hemodialysis, n = 84 patients with hemodialysis, n = 50 renal transplant recipients, n = 114 patients with type 1 and n = 147 patients with insulin treated type 2 diabetes mellitus, n = 51 healthy controls) participated in the trial. RESULTS: Patients with renal insufficiency had significantly higher concentrations of the AGE-products N-epsilon-Carboxymethyllysine (CML) and pentosidine compared with both groups of patients with insulin-treated diabetes mellitus and the healthy controls. In patients with type 1 diabetes there was a positive correlation between HbA1c and the concentration of CML (r = 0.405, p = 0.017) and between the pentosidine-concentration and the serum creatinine-level (r = 0.482, p = 0.001). In type 2 diabetes there was a correlation between CML and diastolic blood pressure (r = 0.239, p = 0.039). In comparison to the healthy controls, patients with renal diseases and patients after kidney transplantation had higher concentrations of total plasma homocysteine and its metabolites. Similar results were found for SDMA and ADMA: Patients with chronic renal insufficiency both with and without hemodialysis had significantly higher values than the renal transplant recipients and healthy controls. A clear influence of cigarette smoking on the levels of the laboratory parameters measured could not be determined in any group; neither in the patients with diabetes mellitus, nor in the patients with renal diseases, nor in the healthy controls. CONCLUSIONS: The present trial demonstrates an increase in the parameters linked to the development of cardiovascular diseases including total plasma homocysteine, its metabolites, the dimethylarginines SDMA and ADMA and advanced glycation end-products depending on the degree of renal insufficiency. Moreover, in patients with insulin-treated diabetes mellitus, the concentrations of the AGE-products CML and pentosidine seem to be strongly influenced by the quality of diabetes control and blood pressure levels. There was no influence of cigarette smoking on the levels of the laboratory parameters measured.