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Objective: To estimate the impact of diabetes on mortality in patients after first major lower extremity amputation (LEA).Research Design and Methods: Using claims data of a nationwide statutory health insurance, we assessed all deaths in a cohort of all 444 patients with a first major LEA since 2005 (71.8% male; mean age 69.1 years; 58.3% diabetic; 43% with amputation above the knee) up to 2009. Using Cox regression, we estimated the time-dependent hazard ratios to compare patients with and without diabetes.Results: The cumulative 5-year mortality was 68% in diabetic and 59% in nondiabetic individuals. In the first course, mortality was lower in diabetic compared with nondiabetic patients. Later, the diabetes risk increased yielding crossed survival curves after 2 to 3 years (time dependency of diabetes; P = 0.003). Age- and sex-adjusted hazard ratios for diabetes were as follows: 0-30 days: 0.50 [95% CI 0.31-0.84]; 31-60 days: 0.60 [0.25-1.41]; 61 days to 6 months: 0.75 [0.38-1.48]; >6-12 months: 1.27 [0.63-2.53]; >12-24 months: 1.65 [0.88-3.08]; >24-36 months: 2.02 [0.80-5.09]; and >36-60 months: 1.91 [0.70-5.21]. The pattern was similar in both sexes. In the full model, significant risk factors for mortality were age (1.05; 1.03-1.06), amputation above the knee (1.50; 1.16-1.94), and quartile category 3 or 4 of the number of prescribed medications (1.64; 1.12-2.40 and 1.76; 1.20-2.59). Further adjustment for comorbidity did not alter the results.Conclusions: In this population-based study, we found a time-dependent mortality risk of diabetes following first major LEA, which may be in part a result of a healthier lifestyle in diabetic patients or the access to specific treatment structures in diabetic individuals. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We evaluated whether the incidence of amputations in one German city (Leverkusen, population approximately 160,000) had decreased between 1990 and 2005. RESEARCH DESIGN AND METHODS: From all three hospitals in the city, we obtained complete lists of nontraumatic lower-limb amputations in 1990-1991 and 1994-2005. Only the first observed amputation in residents of Leverkusen was counted. A total of 692 patients met the inclusion criteria. Data about the population structure, separately for each year of the observation period, were received from the city administration and the Federal Office of Statistics. To test for time trend, we fitted Poisson regression models. RESULTS: Of all subjects, 72% had known diabetes and 58% were male. Mean age was 71.7 years. Incidence rates in the diabetic population (standardized to the estimated German diabetic population per 100,000 person-years) varied considerably between years (maximum 549 in 1990, minimum 281 in 2004). In the diabetic population, the estimated relative risk (RR) per year was 0.976 (95% CI 0.958-0.996, P = 0.0164). The same trend was observed when only amputations above the ankle (n = 352) (RR 0.970 [95% CI 0.943-0.997], P = 0.0318) were considered. Over 15 years, an estimated reduction of amputations above the toe level by 37.1% (95% CI 12.3-54.8) results. There was no significant change of incident amputations in the nondiabetic population (RR 1.022 [0.989-1.056], P = 0.1981). CONCLUSIONS: This finding is likely to be due to improved management of the diabetic foot syndrome after a network of specialized physicians and defined clinical pathways for wound treatment and metabolic control were introduced. [ABSTRACT FROM AUTHOR]

Objective: A reduction of diabetes-related amputations by at least one-half within 5 years was declared a primary objective for Europe (St. Vincent Declaration, 1989). We collected data about incidence rates of amputations in one German city (Leverkusen, with a population of approximately 160,000 inhabitants) between 1990 and 1998 to ascertain a potential change in rates of incidence.Research Design and Methods: From all three hospitals in Leverkusen, we obtained complete lists of lower-limb amputations. From each patient record, diabetic status was determined. Only the first observed amputation was counted for the analysis. We estimated incidence rates of amputations in the entire population, the diabetic population, and the nondiabetic population. To test for time trend, we fitted Poisson regression models, adjusting for age and sex.Results: During, the defined period (the years 1990, 1991, and 1994-1998), 339 patients (all residents of Leverkusen) without previous amputations had nontraumatic lower-limb amputations. Of all subjects. 46% were female. Moreover, 76% of the subjects were known to have diabetes. Mean age was 71.3 years. Incidence rates in the diabetic population (standardized to the estimated German diabetic population, per 100,000 person-years) were as follows: 1990, 549; 1991, 356; 1994, 544; 1995, 386; 1996, 426; 1997, 433; and 1998, 463. The Poisson models showed no significant change of incident amputations over time in the diabetic population or in the nondiabetic population.Conclusions: Beyond random variation, no change of incidence rates could be observed over the past 9 years. More specific interventions are needed to achieve a substantial reduction of diabetes-related amputations. [ABSTRACT FROM AUTHOR]

Objective: To compare hospitalization in a multicenter-based cohort of diabetic children and adolescents (aged 1-19 years) in Germany with that of the general population.Research Design and Methods: Based on standardized documentation, hospital stays after manifestation were ascertained in diabetic subjects 1-19 years of age in 1997. Hospitalization data in the general German population were derived from official statistics. Incidence rates and numbers of hospital days were estimated. Ratios of hospitalization incidences and numbers of hospital days between the diabetic and the general population were calculated. Costs for hospital care in the German diabetic population in 1997 were determined.Results: A total of 5,874 patients came from 61 pediatric centers (52% male, age [mean +/- SD] 12.2 +/- 4.3 years, diabetes duration 4.6 +/- 4.4 years). Hospitalization incidence rates and hospital days per person-year (95% CI) were 0.27 (0.25-0.29) and 1.80 (1.75-1.84) in the diabetic population and 0.0948 (0.0946-0.0949) and 0.6416 (0.6412-0.6420) in the general population. The standardized ratio of hospital incidences was 3.1 (2.9-3.2), and the ratio of numbers of hospital days was 2.8 (2.7-2.9). Costs for hospital care after manifestation were estimated to be $506 (U.S. dollars) per person-year and $12.4 million in the whole German diabetic population aged 1-19 years in 1997; including hospital stays at diabetes onset, total annual costs were $24 million ($970 per person-year).Conclusions: Diabetic children and adolescents in Germany had an approximately three times higher hospitalization risk and three times more hospital days than the age-matched general population. Including hospitalization at diabetes onset, the annual costs of hospital care for the German diabetic population aged 1-19 years amounted to approximately 1% of all costs for hospital care in this age-group. Thus, costs were largely overproportional (diabetes prevalence 0.1%). [ABSTRACT FROM AUTHOR]

Objective: Subclinical inflammation represents a risk factor of type 2 diabetes and several diabetes complications, but data on diabetic neuropathies are scarce. Therefore, we investigated whether circulating concentrations of acute-phase proteins, cytokines, and chemokines differ among diabetic patients with or without diabetic polyneuropathy.Research Design and Methods: We measured 10 markers of subclinical inflammation in 227 type 2 diabetic patients with diabetic polyneuropathy who participated in the population-based MONICA/KORA Survey F3 (2004-2005; Augsburg, Germany). Diabetic polyneuropathy was diagnosed using the Michigan Neuropathy Screening Instrument (MNSI).Results: After adjustment for multiple confounders, high levels of C-reactive protein and interleukin (IL)-6 were most consistently associated with diabetic polyneuropathy, high MNSI score, and specific neuropathic deficits, whereas some inverse associations were seen for IL-18.Conclusions: This study shows that subclinical inflammation is associated with diabetic polyneuropathy and neuropathic impairments. This association appears rather specific because only certain immune mediators and impairments are involved. [ABSTRACT FROM AUTHOR]

Objective: New antidiabetic medications have been introduced during the last decade, but their impact on health care cost is largely unknown. Prescription costs in diabetic patients in primary care in Germany were evaluated (1994-2004)., Research Design and Methods: A total of 46,017 diabetic patients and 46,017 age- and sex-matched control subjects in 400 nationwide practices (2004) were compared with 29,956 diabetic patients and 13,226 control subjects (361 practices) in 1994 (data from IMS HEALTH). Inflation-adjusted age- and sex-standardized costs (ex-manufacturer prices) were calculated., Results: Mean annual total prescription costs per diabetic patient were 559 euros in 2004 (372 euros in 1994), equaling a 60% (standardized) increase (P < 0.01). Average costs for antidiabetic medication were 172 euros in 2004, a 100% increase (P < 0.01). The major antidiabetic cost factor was insulin and analogs, which accounted for 22% of total drug costs in diabetic patients in 2004 (17% in 1994). All oral antidiabetic drugs together accounted for 8% of total costs (6% in 1994). New drugs (glitazones, glinides, and insulins) accounted for 15% of total costs (40% of antidiabetic drugs) in 2004. A 40% increase (387 euros vs. 286) in all non-diabetes-related drugs was due mainly to cardiovascular and lipid-lowering drugs. In nondiabetic patients, only a 30% cost increase was found (210 euros vs. 147; P < 0.01)., Conclusions: Prescription drug costs among diabetic patients increased 60% during the last decade, which was twofold higher than the increase in nondiabetic patients. New types of antidiabetic drugs accounted for a substantial cost share of the overproportional increase for diabetes treatment. Progress in pharmacological therapy is a key driver of drug expenditure growth in diabetes treatment.

Objective: To compare the cost-effectiveness of different type 2 diabetes screening strategies using population-based data (KORA Survey; Augsburg, Germany; subjects aged 55-74 years), including participation data., Research Design and Methods: The decision analytic model, which had a time horizon of 1 year, used the following screening strategies: fasting glucose testing, the oral glucose tolerance test (OGTT) following fasting glucose testing in impaired fasting glucose (IFG) (fasting glucose + OGTT), OGTT only, and OGTT if HbA(1c) was >5.6% (HbA(1c) + OGTT), all with or without first-step preselection (p). The main outcome measures were costs (in Euros), true-positive type 2 diabetic cases, incremental cost-effectiveness ratios (ICERs), third-party payers, and societal perspectives., Results: After dominated strategies were excluded, the OGTT and HbA(1c) + OGTT from the perspective of the statutory health insurance remained, as did fasting glucose + OGTT and HbA(1c) + OGTT from the societal perspective. OGTTs (4.90 per patient) yielded the lowest costs from the perspective of the statutory health insurance and fasting glucose + OGTT (10.85) from the societal perspective. HbA(1c) + OGTT was the most expensive (21.44 and 31.77) but also the most effective (54% detected cases). ICERs, compared with the next less effective strategies, were 771 from the statutory health insurance and 831 from the societal perspective. In the Monte Carlo analysis, dominance relations remained unchanged in 100 and 68% (statutory health insurance and societal perspective, respectively) of simulated populations., Conclusions: The most effective screening strategy was HbA(1c) combined with OGTT because of high participation. However, costs were lower when screening with fasting glucose tests combined with OGTT or OGTT alone. The decision regarding which is the most favorable strategy depends on whether the goal is to identify a high number of cases or to incur lower costs at reasonable effectiveness.

Objective: We collected data on the incidence rates of amputations and their relative risk in diabetic subjects compared with the nondiabetic population., Research Design and Methods: From all three hospitals in a city of approximately 160,000 inhabitants, we obtained complete lists of nontraumatic lower limb amputations. From each patient record, diabetic status was determined. We estimated age-specific and standardized incidence rates of amputations in the diabetic and nondiabetic populations and in the entire population, as well as the relative and attributable risks due to diabetes., Results: Nontraumatic lower limb amputations were performed on 106 residents of Leverkusen (Germany) in 1990 and 1991. Of them, 82 (77.4%) had diabetes. Mean age was 72.0 years. In the case of multiple amputations, only the highest level was counted for the analysis. The following results were standardized to the German population. Incidence rates (100,000(-1) year-1) were determined to be as follows: for all amputations per total population, 33.8; for amputations in diabetic individuals per diabetic population, 209.2; for amputations in nondiabetic individuals per nondiabetic population, 9.4. Relative risk was 22.2; attributable risk among exposed, 0.96; population attributable risk, 0.72. When the study is repeated to monitor the St. Vincent targets (50% reduction), a reduction in the amputation rate in the diabetic population by 46% will be detected with 90% power., Conclusions: We found incidence rates similar to those in the non-Indian population of the U.S. Great relative and population-attributable risks indicate that improving foot care in diabetic individuals appears to be the main target for the reduction of amputations in the general population.