Long-term outcome of persons with diabetic and non-diabetic neuro-osteoarthropathy after foot correction using external fixation.

AIM: Diabetic neuro-osteoarthropathy (Charcot foot) is a serious form of diabetic foot syndrome, often leading to severe deformity of the foot and subsequently to ulcers and osteomyelitis. The aim of this retrospective study was to determine the success rate and long-term outcomes for a Charcot foot operation using external fixation in 115 individuals who underwent surgery between July 2008 and December 2012. METHODS: Some 115 consecutive persons, 78 (68%) men and 37 (32%) women, were enrolled in this study. The eligibility criterion for this retrospective study was reconstructive foot surgery using a Hoffmann II external fixator in diabetic and non-diabetic neuro-osteoarthropathy. The main examination parameters in the follow-up were walking ability, amputation and mortality. Average follow-up was 5.7 (± 3.2) years. RESULTS: Ninety-seven per cent of people were able to walk after the operation with bespoke shoes or an orthosis. At follow-up, 77% were able to walk and 51% were fully mobile even outside the home. Subsequent amputations were performed in 29 individuals (26%), with 17 (15%) minor and 12 (11%) major amputations. Forty-seven individuals died before follow-up, the majority (53%) from cardiovascular events. Average survival time post surgery was 4.5 (± 2.9) years. CONCLUSION: Reconstruction surgery using external fixation is a very useful method for maintaining walking ability in the case of conservatively non-treatable diabetic and non-diabetic neuro-osteoarthropathy. Individuals with severe Charcot foot disease had a low rate of major amputations. Osteomyelitis was the main reason for major amputations.

Changes in incidence of severe hypoglycaemia in people with type 2 diabetes from 2006 to 2016: analysis based on health insurance data in Germany considering the anti-hyperglycaemic medication.

AIM: To investigate the incidence of severe hypoglycaemia over the past 10 years, taking into account changes in anti-hyperglycaemic therapy. METHODS: This retrospective population-based study used German health insurance data. All adults diagnosed with documented type 2 diabetes (extrapolated to the German population: 6.6 million in 2006; 7.9 million in 2011; 8.86 million in 2016) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by Anatomical Therapeutic Chemical (ATC) code. RESULTS: The event rate for severe hypoglycaemia was 460 per 100 000 people in 2006, 490 per 100 000 in 2011 and 360 per 100 000 in 2016. The proportion of people with severe hypoglycaemia receiving sulfonylureas, as well as receiving combination therapy of metformin and sulfonylureas decreased from 2006 to 2016 (23.6% vs. 6.2%) Among those with severe hypoglycaemia in 2006, there were no prescriptions for dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose co-transporter 2 (SGLT2) agonists. The proportions of people with severe hypoglycaemia receiving DPP-4 inhibitors, GLP-1 receptor agonists or SGLT2 agonists in 2011 and 2016 were low. The proportion of people receiving human insulin also decreased (from 11.3% in 2006 to 10.3% in 2011 and 4.3% in 2016); the proportion of people receiving insulin analogues increased from 5.4% in 2006 to 11.5% in 2016. Therapy with mixed insulins was used by 19.7% of people with severe hypoglycaemia in 2006, by 14.0% in 2011 and by 7.3% in 2016. People undergoing therapy with insulin analogues have the highest risk of severe hypoglycaemia adjusted by age, gender, nephropathy diagnosis and year of survey [odds ratio (OR) 14.4, 95% confidence interval (95% CI) 13.5-15.5]. CONCLUSION: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, and decreased in 2016.

Increase in the incidence of severe hypoglycaemia in people with Type 2 diabetes in spite of new drugs: analysis based on health insurance data from Germany.

AIM: To evaluate the use of new anti-hyperglycaemic agents that offer effective glycaemic control while reducing risk of hypoglycaemia, by analysing the incidence rates of severe hypoglycaemia in 2006 vs 2011 in relation to the medication. METHODS: This cross-sectional, population-based study used German health insurance data. All adults diagnosed with Type 2 diabetes mellitus (extrapolated to the German population: 6.35 million in 2006 and 7.52 million in 2011) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by their Anatomical Therapeutic Chemical code, and defined daily doses of each medication were calculated. RESULTS: The severe hypoglycaemic event rate was 460 per 100,000 people/year in 2006 and 490 per 100,000 people/year in 2011. In 2006 and 2011, 10.9% and 7.3%, respectively, of all people with severe hypoglycaemia were on sulfonylureas, while 12.7% and 9.3%, respectively, were on a combination therapy of metformin and sulfonylureas. Among those with severe hypoglycaemia, there were no prescriptions of dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 receptor agonists in 2006, but in 2011, 1.55% and 0.17%, of those with severe hypoglycaemia were receiving the respective treatments. In 2006 vs 2011, human insulin was prescribed for 11.3% vs 10.3% of people with severe hypoglycaemia, while insulin analogues were prescribed for 5.4% vs 8.1%, and mixed human insulins for 19.7% vs 14.0% of patients with severe hypoglycaemia. People receiving insulin analogue therapy had a higher risk of severe hypoglycaemia than those receiving metformin, after adjusting for age, gender, nephropathy diagnosis and year of survey (odds ratio 14.6; CI 13.3-15.9). CONCLUSION: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, despite increased use of newer anti-hyperglycaemic agents and decreased use of insulins.

Trabecular bone score in type 1 diabetes--a cross-sectional study.

UNLABELLED: Trabecular bone score (TBS) seems to provide additive value on BMD to identify individuals with prevalent fractures in T1D. TBS did not significantly differ between T1D patients and healthy controls, but TBS and HbA1c were independently associated with prevalent fractures in T1D. A TBS cutoff <1.42 reflected prevalent fractures with 91.7 % sensitivity and 43.2 % specificity. INTRODUCTION: Type 1 diabetes (T1D) increases the risk of osteoporotic fractures. TBS was recently proposed as an indirect measure of bone microarchitecture. This study aimed at investigating the TBS in T1D patients and healthy controls. Associations with prevalent fractures were tested. METHODS: One hundred nineteen T1D patients (59 males, 60 premenopausal females; mean age 43.4 ± 8.9 years) and 68 healthy controls matched for gender, age, and body mass index (BMI) were analyzed. The TBS was calculated in the lumbar region, based on two-dimensional (2D) projections of DXA assessments. RESULTS: TBS was 1.357 ± 0.129 in T1D patients and 1.389 ± 0.085 in controls (p = 0.075). T1D patients with prevalent fractures (n = 24) had a significantly lower TBS than T1D patients without fractures (1.309 ± 0.125 versus 1.370 ± 0.127, p = 0.04). The presence of fractures in T1D was associated with lower TBS (odds ratio = 0.024, 95 % confidence interval (CI) = 0.001-0.875; p = 0.042) but not with age or BMI. TBS and HbA1c were independently associated with fractures. The area-under-the curve (AUC) of TBS was similar to that of total hip BMD in discriminating T1D patients with or without prevalent fractures. In this set-up, a TBS cutoff <1.42 discriminated the presence of fractures with a sensitivity of 91.7 % and a specificity of 43.2 %. CONCLUSIONS: TBS values are lower in T1D patients with prevalent fractures, suggesting an alteration of bone strength in this subgroup of patients. Reliable TBS cutoffs for the prediction of fracture risk in T1D need to be determined in larger prospective studies.

Metabolic control and hypoglycaemia in people with type 2 diabetes on conventional or intensified insulin therapy: a 22 year retrospective single centre survey.

BACKGROUND: Multiple insulin injection therapy can easily be adapted to the patient's needs. Therefore, it is supposed that more intensive insulin therapy is associated with better metabolic control and less hypoglycaemia compared with a conventional insulin strategy in patients with type 2 diabetes. METHODS: HbA1c and incidence of non-severe and severe hypoglycaemia were analysed with regard to the strategy of insulin therapy [multiple insulin injection therapy with preprandial insulin with or without basal insulin or conventional insulin therapy with twice-daily premix insulin] from 20 943 visits of 1417 people treated with insulin with type 2 diabetes in a university outpatient department for endocrinology and metabolic diseases over a period of 22 years. RESULTS: Multiple insulin injection therapy was used in 13 896 (66.4%) of all 20 942 visits. Compared with conventional insulin therapy, these patients were younger (62.0 vs 68.7 years; p < 0.001), had a slightly longer diabetes duration (16.5 vs 15.8 years; p < 0.001) and higher body mass index (32.8 vs 30.9 kg/m(2) ; p < 0.001), a higher insulin dose (76.4 vs 46.5 IU/day; p < 0.001), more frequent blood glucose monitorings/week (24.2 vs 14.8; p < 0.001), a slightly lower HbA1c [7.7 (61.2) vs 7.9% (62.9 mmol/mol); p < 0.001] but more non-severe hypoglycaemic incidences per week (0.3 vs 0.2; p = 0.01). Episodes of severe hypoglycaemia were rare and comparable (0.01/patient/year) with both insulin therapy strategies. CONCLUSIONS: Multiple insulin injection therapy and conventional insulin therapy yielded comparable metabolic control with HbA1c below 8% (63.9 mmol/mol), but multiple insulin injection therapy is associated with higher body mass index and higher incidence of non-severe hypoglycaemia. Copyright © 2016 John Wiley & Sons, Ltd.

Postprandial self-monitoring of urine glucose reflects glycaemic control in people with relatively well controlled Type 2 diabetes mellitus not treated with insulin: a retrospective cohort study.

AIM: To analyse the association of self-monitoring of urine glucose with HbA1c concentration in people with Type 2 diabetes not treated with insulin. METHODS: We studied the association of postprandial self-monitored urine glucose with HbA1c concentrations in 264 people with Type 2 diabetes (mean age 62.4 years, time since diagnosis of diabetes 6.8 years and HbA1c 50 mmol/l). All patients took part in a diabetes treatment and teaching programme. HbA1c values were adjusted according to the Diabetes Control and Complication Trial. RESULTS: The mean ( ± sd) HbA1c concentration for the patients with constant negative urine glucose tests (56.1% of patients) was 46 ( ± 6) mmol/mol [6.4 ( ± 0.6)%]. This was significantly lower than in patients with < 50% positive urine glucose tests (33.3% of patients): mean ( ± sd) HbA1c was 53 ( ± 8) mmol/mol [7.0( ± 0.7)%] and also lower than in patients with ≥50% positive tests (10.6% of patients): mean ( ± sd) HbA1c of 57 ( ± 8) mmol/mol [7.4 ( ± 0.7)%]; P < 0.001. There was a significant correlation between the urine glucose test results and HbA1c (r = 0.416; P < 0.001). CONCLUSION: HbA1c concentrations were observed to be in the near-normal range for people with Type 2 diabetes not receiving insulin treatment who were negative for postprandial glucosuria. Urine glucose self-monitoring is a cheap and effective method to determine the quality of glucose control.

Use of snacks in insulin-treated people with diabetes mellitus and association with HbA1c , weight and quality of life: a cross sectional study.

AIM: Insulin therapies with prandial injections offer the possibility to skip snacks or omit meals. It is unclear how many people with insulin-treated diabetes mellitus eat snacks and whether they snack for their own comfort or only on the recommendation of healthcare professionals. METHODS: In 2004, 163 consecutive people with insulin-treated diabetes seen in a university outpatient department were interviewed regarding their diet and degree of satisfaction with their meals. Fifty-five had Type 1 diabetes [age 47 years; diabetes duration 18 years; BMI 27 kg/m(2) ; HbA1c 62 mmol/mol (7.8%)], 53 had Type 2 diabetes with biphasic insulin therapy [age 68 years; diabetes duration 17 years; BMI 31 kg/m(2) ; HbA1c 60 mmol/mol (7.6%)] and 55 had Type 2 diabetes with prandial insulin therapy [age 60 years; diabetes duration 16 years; BMI 33 kg/m(2) ; HbA1c 59 mmol/mol (7.6%)]. RESULTS: Eighty per cent of those with Type 1 diabetes ate snacks, together with 77% of the Type 2 diabetes/biphasic group and 62% of the Type 2 diabetes/prandial group. Most participants (91% Type 1 diabetes, 88% Type 2 diabetes/biphasic group, 82% Type 2 diabetes/prandial group) liked to have snacks. The time at which they ate snacks was the same for both diabetes types. There were no differences between participants with Type 1 diabetes who snacked and those who did not in terms of age (P = 0.350), BMI (P = 0.368), HbA1c (P = 0.257) and time since diagnosis (P = 0.846). Participants with Type 2 diabetes who ate snacks were older than those who did not (biphasic: P = 0.006; prandial: P = 0.008). There were no differences in terms of BMI (biphasic: P = 0.731; prandial: P = 0.393), HbA1c (biphasic: P = 0.747; prandial: P = 0.616) and time since diagnosis (biphasic: P = 0.06; prandial: P = 0.620). CONCLUSIONS: Most people with insulin-treated diabetes eat snacks voluntarily and not because of physicians' instructions. There were no correlations between the use of snacks and HbA1c , BMI and time since diagnosis, except that the participants with Type 2 diabetes who ate snacks were older.

Healthcare utilization of people with type 2 diabetes in Germany: an analysis based on health insurance data.

AIMS: This population-based study assesses the healthcare utilization of people with Type 2 diabetes by analysing routine data from Allgemeine Orts-Krankenkasse (AOK), the largest statutory health insurance provider in Germany. METHODS: Anonymized billing data from all AOK-insured persons with at least one day of insurance during the evaluation year 2010 were analysed. Treatment and cost data from all areas of inpatient and outpatient care were available, as was information regarding patient age and sex. International Classification of Diseases (ICD-10) diagnosis and Anatomical Therapeutic Chemical (ATC) classification were used to identify 2.7 million insured persons with diabetes. RESULTS: The age- and sex-standardized prevalence of Type 2 diabetes was 9.8%. Of those patients identified, 33.9% had at least one diabetes-related complication and 83.0% had a diagnosis of hypertension. Almost two-thirds (63.1%) received antihyperglycaemic medication. Metformin and sulfonylurea were prescribed most often; medications without proof of benefit in endpoint studies were prescribed much less frequently. People without diabetes were admitted to hospital only half as often as those with Type 2 diabetes. The projected total expenditure in Germany for all people with Type 2 diabetes amounted to approximately €33.3 billion in 2010. CONCLUSIONS: This study shows an increase in both the prevalence of diabetes and treatment costs. The majority of people with Type 2 diabetes were aged 70 years or older. One third of this group has diabetes-related complications. Antihyperglycaemic medications without proof of benefit in endpoint studies were prescribed much less frequently than drugs with proof of benefit.

High serum pentosidine but not esRAGE is associated with prevalent fractures in type 1 diabetes independent of bone mineral density and glycaemic control.

UNLABELLED: Fracture risk in type 1 diabetes (T1D) is supposed to be underestimated by bone mineral density (BMD). Individuals with T1D had more prevalent fractures in a cross-sectional study. Serum levels of pentosidine, an advanced glycation end product, and poor glycaemic control were associated with prevalent fractures independent of BMD. INTRODUCTION: Type 1 diabetes (T1D) is associated with increased fracture risk. Bone mineral density (BMD) underestimates the risk of fractures in some individuals. The accumulation of advanced glycation end products (AGEs) impairs bone matrix and reduces bone strength. METHODS: In a cross-sectional study, 128 men and premenopausal women with T1D were evaluated. We compared traditional risk factors for fractures, BMD, parameters of bone metabolism and AGEs in individuals with and without prevalent fractures. An independent association of serum AGE levels with prevalent fractures was investigated. RESULTS: Individuals with prevalent fractures exhibited a longer duration of T1D, higher HbA1c and more diabetic-related complications. BMD at the femoral neck (z-score -0.76 ± 0.94 vs. -0.23 ± 1.02; p = 0.031) and total hip (z-score -0.54 ± 0.93 vs. 0.11 ± 1.11; p = 0.017) was lower in those with prevalent fractures. Individuals with fractures had higher pentosidine levels (164.1 ± 53.6 vs. 133.2 ± 40.4; p = 0.002). The levels of N-ε-(carboxymethyl)-lysine (CML) and endogenous secretory receptor for AGEs (esRAGE) did not significantly differ. Multivariate logistic regression analysis adjusted for age, BMI, family history of fractures, smoking, vitamin D deficiency, BMD at lumbar spine, femoral neck and total hip identified pentosidine levels and HbA1c as independent factors associated with prevalent fractures (odds ratio 1.02, 95% CI 1.00-1.03/pmol/ml increase of pentosidine; p = 0.008 and odds ratio 1.93, 95% CI 1.16-3.20 per percentage increase of HbA1c; p = 0.011). CONCLUSIONS: The pentosidine levels but not BMD are independently associated with prevalent fractures. Impaired bone quality in T1D may result from increased AGE formation.

Frequency of self-adjustment of insulin dose and metabolic control in Type 2 diabetes -is there an association?

AIM: To investigate the supposition that self-adjustment of insulin dose will improve metabolic control in patients with Type 2 diabetes. METHODS: The number of self-adjustments of insulin dose was checked in a cross-sectional study involving 300 patients with Type 2 diabetes in a university outpatient department, who were insulin treated. RESULTS: One hundred and ninety-three patients (64%) performed insulin dose adjustments at least once in 14 days. The mean number of dose adjustments was 17.4 per 14 days. Patients with self-adjustments of insulin dose were younger (65.6 vs. 68.9 years), had a higher social status score (11.1 vs. 9.8) and a higher insulin dose (68.8 vs. 53.6 IU/day) than patients without dose adjustments. Each insulin dose adjustment was associated with an HbA(1c) decrease of 0.016% (P = 0.004). Any additional blood glucose self measurement was associated with an HbA(1c) increase of 0.019% (P = 0.038). CONCLUSIONS: Two-thirds of patients with Type 2 diabetes, who have undergone training in how to manage their condition, practise insulin dose self-adjustments. A weak association was observed between insulin dose adjustments and HbA(1c).

Differences in the quality of diabetes care caused by social inequalities disappear after treatment and education in a tertiary care centre.

AIM: To assess the relationship between social status and quality of diabetes care in a tertiary care centre in Germany. METHODS: Social status was assessed in 940 consecutive patients in a university outpatient department by a questionnaire. The assessment comprised three components: education, highest professional position and household net income (total score 3-21). Quality of diabetes care was measured by HbA(1c) , blood pressure and BMI. The influence of social status on quality measures was analysed at entry and last visit by fitting linear mixed models. RESULTS: At the entry visit, patients with lower social status had a higher HbA(1c) compared with patients with higher status (0.06% per each point of social score difference). After a mean follow- up of 6.0 years (Type 2 diabetes) and 9.4 years (Type 1 diabetes) no significant differences in HbA(1c) could be found. However, difference in BMI (-0.41 kg/m² per each point of social score) persisted at last observation. Blood pressure was only negligibly affected by the care programme. CONCLUSIONS: Low social status is associated with worse quality of diabetes care at entry in a tertiary care centre. The differences in HbA(1c) disappeared after treatment and structured education, whereas the difference in BMI persisted. There was no significant influence of social status or treatment on blood pressure.

[Rare differential diagnosis in a 40-year old patient with sleep apnea syndrome]. / Seltene Differenzialdiagnose bei einem 40-jährigen Patienten mit Schlafapnoe-Syndrom.

Respiratory disorders are common and important complications in acromegaly. The prevalence of sleep apnea syndrome (SAS) in this group of patients is high (20%-50%). Consequences of SAS are serious and associated with increased morbidity and mortality, mainly as a result of cardiovascular complications. The symptoms of sleep apnea are often reversible with treatment. We report on an acromegaly patient presenting with excessive snoring and severe headaches caused by sleep apnea.

Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes.

OBJECTIVE: Regular human insulin is usually recommended with an injection-meal interval. It is not known how many patients follow these recommendations and, of those who do, the injection-meal interval remains incompletely studied. We investigated the injection-meal interval in patients with Type 1 and Type 2 diabetes and the association with metabolic control in routine care. METHODS: Four hundred and seventy-one consecutive patients with Type 1 or Type 2 diabetes were interviewed to determine their injection-meal interval in a university outpatient clinic setting in Germany in 2006. Four hundred and thirty-three interviews were suitable for analysis (143 Type 1 diabetes, 290 Type 2 diabetes). HbA(1c) was Diabetes Control and Complications Trial adjusted. RESULTS: Among those with Type 1 diabetes, 27% 'always', 27% 'sometimes' and 46% 'never' used an injection-meal interval. Forty-three per cent of patients with Type 2 diabetes always used an injection-meal interval, 12% sometimes and 45% never. Among patients with Type 1 diabetes, there was no difference in HbA(1c) between those who always used an injection-meal interval (n=39, age 58 years, duration of diabetes 21.1 years, BMI 28.7 kg/m², HbA(1c) 7.50%/58 mmol/mol) compared with those who never used an injection-meal interval (n=66, age 47.3 years, duration of diabetes 17.4 years, BMI 27.3 kg/m², HbA(1c) 7.55%/59 mmol/mol). Among patients with Type 2 diabetes, HbA(1c) in those who always used an injection-meal interval (n = 124, age 65 years, duration of diabetes 13.8 years, BMI 32.6 kg/m², HbA(1c) 7.31%/56 mmol/mol) is 0.27% lower compared with those who never used an injection-meal interval (n=130, age 64.3 years, duration of diabetes 16 years, BMI 32.8 kg/m², HbA(1c) 7.58%/59 mmol/mol). CONCLUSION: Nearly half of insulin-treated patients do not use an injection-meal interval. We found no significant association between adherence to injection-meal interval and HbA(1c) in patients with Type 1 diabetes, but a slightly lower HbA(1c) in patients with Type 2 diabetes who always use an injection-meal interval.

Glycaemic control is positively associated with prevalent fractures but not with bone mineral density in patients with Type 1 diabetes.

AIM: There are conflicting data regarding the risk of osteoporosis in patients with Type 1 diabetes. We investigated an association between diabetes, bone mineral density and prevalent fractures. METHODS: A single-centre, cross-sectional study of men and pre-menopausal women with Type 1 diabetes (n = 128) and a matched control group (n = 77) was conducted. The primary outcome measure was bone mineral density and secondary measures were markers of bone metabolism and prevalent fractures. RESULTS: Hip and total body bone mineral densities were significantly lower in women with diabetes compared with control subjects. In men, no difference in bone mineral density was found. A multivariate regression analysis in women with diabetes revealed higher BMI as the strongest predictor of higher total hip, femoral neck and total body bone mineral density, whereas previous fractures were inversely associated with total hip bone mineral density and C-terminal telopeptide of type I collagen with total body bone mineral density. Poor long-term glycaemic control was not associated with low bone mineral density. Fracture frequency was higher in patients with diabetes compared with control subjects (1.64 vs. 0.62 per 100 patient-years; P < 0.05). In a multivariable model, long-term HbA(1c) control was associated with increased clinical fracture prevalence (OR 1.92; 95% CI 1.09-2.75) in those with diabetes. CONCLUSIONS: Type 1 diabetes contributes to low bone mineral density in women. Previous fractures and low BMI were strong predictors of impaired bone mineral density and should therefore be considered in risk estimation. Fractures are more frequent in Type 1 diabetes. Long-term hyperglycaemia may account for impaired bone strength, independently from bone mineral density.

[Diagnostic pitfalls with Cushing's syndrome]. / Diagnostische Fallstricke beim Cushing-Syndrom.

Adrenal cortical carcinoma is a rare diagnosis and may present with hormone secretion. A histological differentiation between an adrenal cortical adenoma and carcinoma can be very difficult. However, a fast diagnosis including staging and complete surgical resection is pivotal for the prognosis of an adrenal cortical carcinoma. Metastasing adrenal cortical carcinoma should be treated with a mitotane based chemotherapy, and inclusion in the "firm-act study" is highly recommended. The present case report demonstrates the diagnostic pitfalls in a female patients with Cushing's syndrome who suffered from metastasing adrenal cortical carcinoma.

[HbA1c-mapping--evaluation of a new method for population-based monitoring of metabolic control in patients with diabetes mellitus]. / HbA1c-Kartografierung--Evaluation eines neuartigen versorgungs-epidemiologischen Verfahrens zum Monitoring der Stoffwechselkontrolle von Patienten mit Diabetes mellitus.

AIM: The purpose of this study was to analyse metabolic control in patients with diabetes mellitus in primary care in Thuringia and to evaluate HbA1c mapping as a newly proposed method for population-based continuous monitoring of metabolic control in primary care. METHODS: A cross-sectional study (2nd quarter 2005) using the electronic data bases of Thuringian medical laboratories (HbA1c, postal code of GP) was undertaken. The study population comprised all Thuringian patients with diabetes mellitus who were treated in ambulatory care. A comparison was made between data from HbA1c mapping and data collected by GPs (general practitioner) of two selected areas. RESULTS: We collected 89,407 HbA1c tests by HbA1c mapping: the following values were obtained - mean HbA1c: 6.73+/-1.27%; HbA1c >/=7%: 32.6%; HbA1c >/=10%: 2.4% of all HbA1c tests. The mean HbA1c was 0.2% lower in HbA1c mapping compared to data collection in GPs (HbA1c 6.8+/-1.32% vs. 7.02+/-1.26%, p<0.001). The percentage of HbA1c tests below 7% was higher, HbA1c test results between 7% and 9% were less frequent in HbA1c mapping. Patient data were as follows: type 2 diabetes 98.7%, female gender: 57%, age 69.8+/-11.6 years, insulin therapy 28.8%. CONCLUSIONS: The Thuringian cross-sectional study 2005 showed acceptable results for metabolic control in ambulatory care. The results of HbA1c mapping were comparable to the data on glycaemic control of patients with diabetes mellitus in ambulatory care.

Flexible, intensive insulin therapy and dietary freedom in adolescents and young adults with Type 1 diabetes: a prospective implementation study.

AIMS: To assess the outcome of a Diabetes Treatment and Teaching Programme (DTTP) on glycated haemoglobin (HbA1c), severe hypoglycaemia (SH) and severe ketoacidosis (SKA) in adolescents and young adults with Type 1 diabetes. METHODS: Quality-assurance project with assessment of participants 1 year after participation in a DTTP (5-day inpatient course, groups < or = 10 patients, fixed curriculum of education/training, introduction of dietary freedom). Before-after analyses of participants aged 12-15, 15-18, 18-21 and 21-24 years. Main outcome measures were HbA1c, SH and SKA. RESULTS: For the 1592 participants, aged 12 to 24 years, mean age at enrolment was 19 +/- 3 years, mean duration of diabetes was 7.3 +/- 5.4 (range 0.3-24) years, mean baseline HbA1c declined from 8.8 +/- 2.3% to 8.1 +/- 2.0%. The incidence of SH was 0.31 vs. 0.11 events/patient/year; the incidence of SKA 0.17 vs. 0.07 events/patient/year. In mixed effects models taking into account effects of centres, age and diabetes duration, the mean difference was -0.64%[P < 0.001, 95% confidence interval (CI) -0.79 to -0.5] for HbA1c, -0.2 events/patient/year (P < 0.0001, 95% CI -0.28 to -0.12) for SH and -0.1 events/patient/year (P < 0.0001, 95% CI -0.14 to -0.06) for SKA. CONCLUSIONS: Adolescents and young adults with Type 1 diabetes benefit from participation in a standard DTTP for flexible, intensive insulin therapy and dietary freedom.

Prevalence of the diabetic foot syndrome at the primary care level in Germany: a cross-sectional study.

AIMS: The diabetic foot syndrome (DFS) is an important complication of diabetes mellitus resulting in amputations, disability and reduced quality of life. DFS is preventable. The aim was to investigate the prevalence of the DFS at the primary care level in Germany. METHODS: This was a cross-sectional study of the prevalence of DFS, associated factors and glycaemic control at the primary care level in Germany. We examined an unselected sample of participants with known diabetes who were insured by Deutsche BKK, a large healthcare insurer. RESULTS: Three hundred and forty-one general practitioners examined 4778 participants with diabetes mellitus: 366 (7.7%) participants (mean age 49 +/- 16 years) had Type 1 and 4412 participants (mean age 66 +/- 10 years) had Type 2 diabetes. DFS was diagnosed in 138 patients, resulting in a prevalence of 3.6%[95% confidence interval (CI) 1.9, 6.0] in Type 1 and 2.8% (95% CI 2.3, 3.4) in Type 2 diabetes. DFS was independently associated with age, duration of diabetes, height, current smoking and insulin therapy. There was no significant effect of glycaemic control on the risk of DFS. The prevalence of other abnormal foot findings was: peripheral neuropathy 9.7%, peripheral arterial disease 14.8% (absent dorsalis pedis), 12.4% (absent tibialis posterior), acute diabetic foot ulcer 0.8%, amputations of lower extremities 1.5%, and amputations limited to toes 0.5%. CONCLUSIONS: The prevalence of the DFS at the primary care level in Germany is 2.9%. Almost 50% of patients with DFS had major or minor amputations. Common risk factors such as hyperkeratosis and poor glycaemic control can be modified. Effective therapeutic approaches in addition to methods for primary and secondary prevention of DFS should be used more widely.

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.

Improved metabolic control results in better myogenic response of retinal arterioles in patients with diabetes mellitus type 1.

AIMS: The retina is protected against high blood pressure by the myogenic constriction of arterioles (the Bayliss effect). Hyperglycemia impairs this retinal autoregulation by endothelial dysfunction. The purpose of this prospective pilot study was to test whether improved metabolic control results in a measurable effect on the myogenic response of human retinal arterioles to acute increases in blood pressure. METHODS: The Bayliss effect was measured in 25 patients with diabetes mellitus by the Retinal Vessel Analyzer (RVA), both before and after participation in a treatment and teaching program for intensified insulin therapy with the goal of improved metabolic control. After 12 months, 17 subjects still fulfilled the inclusion criteria and underwent an identical measurement. The Wilcoxon test was used for statistical analysis. RESULTS: During the first session, a rise in mean arterial pressure (MAP) of 20.2 +/- 8.6 mm Hg was followed by an arterial vasoconstriction of -3.2 +/- 2.9%. The educational program resulted in a significant drop in Hb(A1c) levels (9.4 +/- 1.9 vs. 6.9 +/- 0.98%). Eight subjects did not meet the inclusion criteria after 12 months. Seventeen subjects were remeasured and a rise in blood pressure of 19.5 +/- 9.9 mm Hg in the second session was associated with a significantly improved arterial vasoconstriction of -5.9 +/- 2.7% (session I vs. session II, p = 0.006). CONCLUSION: The myogenic response of the arterial wall in human retinal arterioles was significantly improved by the therapeutic intervention.