Diabetes Center Mergentheim

Bad Mergentheim, Germany

Diabetes Center Mergentheim

Bad Mergentheim, Germany
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Hermanns N.,Research Institute Diabetes Academy Mergentheim | Hermanns N.,Diabetes Center Mergentheim | Hermanns N.,University of Bamberg | Schmitt A.,Research Institute Diabetes Academy Mergentheim | And 13 more authors.
Diabetes Care | Year: 2015

OBJECTIVE Subclinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis. Since there is a lack of specific intervention concepts for this patient group, a selfmanagement- oriented group program (DIAMOS [Diabetes Motivation Strengthening]) was newly developed and evaluated in a randomized trial. RESEARCH DESIGN AND METHODS DIAMOS is composed of cognitive behavioral interventions aiming at the reduction of diabetes distress. The active control group (CG) received diabetes education. The primary outcome was depressive symptoms. Secondary outcomes were diabetes distress, well-being, self-care behavior, diabetes acceptance, diabetes treatment satisfaction, HbA1c, and subclinical inflammation. RESULTS Two hundred fourteen participants (mean age 43.3 6 13.3 years, female sex 56.5%, type 2 diabetes 34.1%, mean diabetes duration 14.2 6 10.5 years, HbA1c 8.9 6 1.8%, BMI 28.7 6 71 kg/m2) were randomized. The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms (Center for Epidemiologic Studies Depression Scale score) in the DIAMOS group compared with the CG (D3.9 [95% CI 0.6-7.3], P = 0.021). Of the secondary variables, the Patient Health Questionnaire-9 (D1.7 [95% CI 0.2-3.2], P = 0.023), Problem Areas in Diabetes scale (D8.2 [95% CI 3.1-13.3], P = 0.002), and Diabetes Distress Scale scores (D0.3 [95% CI 0.1-0.5], P = 0.012) displayed significant treatment effects. Moreover, the risk of incident major depression in the DIAMOS group was significantly reduced (odds ratio 0.63 [95% CI 0.42-0.96], P = 0.028). Inflammatory variables were not substantially affected. CONCLUSIONS DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabetic patients with subclinical depression. DIAMOS also has a preventive effect with respect to the incidence of major depression. © 2015 by the American Diabetes Association.


Hermanns N.,Research Institute Diabetes Academy Mergentheim FIDAM | Hermanns N.,University of Bamberg | Hermanns N.,Diabetes Center Mergentheim | Kulzer B.,Research Institute Diabetes Academy Mergentheim FIDAM | And 6 more authors.
Diabetes Research and Clinical Practice | Year: 2013

Objective: In a randomized, multi-centre trial, the efficacy of a self-management-oriented education programme (PRIMAS) for people with type 1 diabetes was compared with an established education programme as control group (CG). Primary outcome was the effect on glycaemic control in a 6-month follow-up. Secondary outcomes were the impact on emotional aspects, self-management related aspects and hypoglycaemia problems. Methods: The study was conducted in an outpatient setting. 160 participants were randomized. Baseline characteristics in PRIMAS and CG were similar (age 45.1±13.5 vs. 45.9±13.1 years, p=716; diabetes duration 18.8±12.3 vs. 19.8±13.4 years, p=615; BMI 26.5±4.6 vs. 27.5±5.0kg/m2, p=236; HbA1c 8.3±1.1 vs. 8.1±1.0%, p=236). Results: At follow-up there was a significant 0.4 percentage points greater reduction of HbA1c in PRIMAS compared to CG (δ -0.4 ± 1.0% vs δ 0.0 ± 0.6%; p= .012). Also, diabetes-related distress (δ -0.3 ± 0.7 vs. -0.1 ± 0.4, p= .032) and dissatisfaction with diabetes treatment (δ -3.3 ± 6.9 vs. -1.9 ± 5.6, p= .024) decreased more in PRIMAS. Diabetes empowerment (δ 2.6 ± 5.9 vs. 0.8 ± 5.1, p= .037) and diabetes self-efficacy (δ 1.4 ± 3.6 vs. 0.2 ± 4.0, p= .013) increased in PRIMAS. Incidence of severe hypoglycemia, hypoglycemia awareness, diabetes knowledge, and self-care behaviour improved in both groups with no significant differences between groups. Conclusion: PRIMAS is more effective in lowering HbA1c than a previously established education programmes and also showed superiority in reducing diabetes-related distress and increasing diabetes empowerment, diabetes self-efficacy and satisfaction with insulin therapy. © 2013 Elsevier Ireland Ltd.


PubMed | Internal Medicine, Hospital Malteser St Johannes Stift, Diabetes Center Mergentheim, Kepler University Hospital and 5 more.
Type: | Journal: Journal of affective disorders | Year: 2016

Like other mental illnesses, depression is a culturally sensitive topic. Hence, findings cannot be transferred between countries. We investigated the frequency of depressed mood and its association with diabetes-related factors in a large type 2 diabetes (T2D) cohort from real-life care in Germany.17,563 adults (median [IQR]: 64.5[55.9-71.1] years) from the multicenter diabetes follow-up registry, DPV (diabetes prospective follow-up), were investigated. All had completed the WHO-5 questionnaire, a screening tool for depression. Logistic regression was applied to study the association of demographic and diabetes-related factors with depressed mood (SAS 9.4). P<0.05 was considered significant.Using a WHO-5 cut-off of <13, 27.4% of patients were at risk for depressed mood. A clinical depression diagnosis was recognized in 8.4%. Female sex (OR: 1.5[95%-CI: 1.4-1.6]), young age (1.2[1.1-1.4]), longer diabetes duration (1.2[1.1-1.3]), and living in Northern Germany (1.3[1.2-1.4]) were each associated with increased odds for depressed mood. After adjusting for these confounders, worse glycemic control (1.4[1.3-1.5]), insulin use (1.3[1.2-1.4]), myocardial infarction (1.3[1.2-1.5]), stroke (1.8[1.5-2.0]), retinopathy (1.4[1.3-1.6]), renal failure (1.4[1.2-1.8]), diabetic foot syndrome (1.3[1.2-1.4]), severe hypoglycemia (1.5[1.2-1.9]), two or more inpatient admissions (2.1[1.8-2.4]), and longer duration of hospital stay (1-<14 days: 1.3[1.2-2.3]; >14 days: 2.1[1.9-2.3]) were related to depressed mood.Due to the cross-sectional design, no causality can be drawn.In T2D, depressed mood is not uncommon. However, in routine care a clinical depression might be missed and regular screening is advisable. Besides the well-known associations with depressed mood, northern German residence and mainly life-compromising diabetes comorbidities were identified as related factors.


Ehrmann D.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Diabetes Center Mergentheim | Haak T.,Research Institute of the Diabetes Academy Mergentheim FIDAM | And 3 more authors.
Diabetic Medicine | Year: 2015

Aim: To investigate the longitudinal bi-directionality of diabetes-related distress and depressive symptoms. Methods: A total of 509 patients receiving intensified insulin therapy completed the Centre for Epidemiological Studies Depression scale questionnaire for the assessment of depressive symptoms as well as the Problem Areas in Diabetes questionnaire for the assessment of diabetes-related distress at baseline and at 6-month follow-up. Separate logistic and linear regression analyses for incidence and persistence were performed with demographic (age, gender, BMI) and medical (diabetes type, HbA1c, diabetes duration, late complications) control variables. Results: Diabetes-related distress at baseline increased the risk of the incidence of elevated depressive symptoms by 2.56-fold (odds ratio 2.56; 95% CI 1.15-5.72; P=0.02) when controlling for demographic and medical variables. In addition, diabetes-related distress at baseline doubled the chance of the persistence of elevated depressive symptoms (odds ratio 2.04, 95% CI 1.04-3.99; P=0.04) when controlling for demographic and medical variables. The chance of having persistent elevated diabetes-related distress was increased 5.94-fold (odds ratio 5.94, 95% CI 2.60-13.59; P<0.0001) when elevated depressive symptoms were present at baseline. None of the medical variables had an influence on incidence or persistence. Conclusions: Diabetes-related distress was identified as a risk factor for the incidence and persistence of depressive symptoms. Reducing diabetes-related distress could help to prevent the development of elevated depressive symptoms. Furthermore, depressive symptoms were identified as an amplifier for diabetes-related distress. Diabetes-related distress and depressive symptoms were independent risk factors for each other and should be monitored in routine care to disentangle their influence. © 2015 Diabetes UK.


Petrak F.,Ruhr University Bochum | Petrak F.,Center for Psychotherapy Wiesbaden | Herpertz S.,Ruhr University Bochum | Albus C.,University of Cologne | And 9 more authors.
Diabetes Care | Year: 2015

OBJECTIVE: This study compared the long-term efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) with sertraline in patients with diabetes and depression who initially responded to short-term depression treatment. RESEARCH DESIGN AND METHODS: A randomized controlled single-blind trial was conducted in 70 secondary care centers across Germany comparing 12 weeks of CBT with sertraline in 251 patients with type 1 or 2 diabetes (mean HbA1c 9.3%, 78 mmol/mol) and major depression (Structured Clinical Interview for DSM-IV [SCID]). After 12 weeks, treatment responders (≥50% reduction Hamilton Depression Rating Scale [HAMD-17]) were included in the 1-year study phase where CBT patients were encouraged to use bibliotherapy and sertraline patients received continuous treatment. We analyzed differences for HbA1c (primary outcome) and reduction (HAMD-17) or remission (SCID) of depression from baseline to the 1-year follow-up using ANCOVA or logistic regression analysis. RESULTS: After 12 weeks, 45.8% of patients responded to antidepressant treatment and were included in the 1-year study phase. Adjusted HbA1c mean score changes from baseline to the end of the long-term phase (-0.27, 95% CI -0.62 to 0.08) revealed no significant difference between interventions. Depression improved in both groups, with a significant advantage for sertraline (HAMD-17 change: -2.59, 95% CI 1.15-4.04, P < 0.05). CONCLUSIONS: Depression improved under CBT and sertraline in patients with diabetes and depression, with a significant advantage for sertraline, but glycemic control remained unchanged. CBT and sertraline as single treatment are insufficient to treat secondary care diabetes patients with depression and poor glycemic control. © 2015 by the American Diabetes Association.


Making appropriate treatment decisions for patients newly diagnosed with type 2 diabetes mellitus (T2DM) and severe hyperglycemia (glycated hemoglobin [HbA1c]>10% or fasting plasma glucose≥250 mg/dL) presents a formidable challenge to primary care physicians. Extreme defects in insulin secretion make it unlikely that these patients will achieve glycemic targets with metformin monotherapy. Additionally, uncontrolled hyperglycemia is associated with an increased risk of short-term acute complications, such as hyperosmolar coma, and long-term complications affecting the micro- and macrovasculature. Thus, severely hyperglycemic patients require prompt, intensive treatment to re-establish glycemic control. Current guidelines indicate that either initial insulin therapy or initial combination therapy with metformin plus non-insulin drug(s) are the treatments of choice for these challenging-to-treat patients. This mini-review examines the clinical evidence supporting these two treatment options, with particular reference to the findings of a phase 3 study of treatment with an initial combination of metformin plus the dipeptidyl peptidase-4 inhibitor, linagliptin. Intensive insulin therapy can induce sustained euglycemia and improve beta-cell function in newly diagnosed patients. However, insulin use is associated with an increased risk of adverse events, such as hypoglycemia and weight gain. These potentially serious side effects cause concern among patients and physicians, and are a major barrier to initiating and maintaining adherence to insulin treatment. In the phase 3 study, open-label treatment of severely hyperglycemic patients (HbA1c≥11.0%) with linagliptin plus metformin resulted in a mean change in HbA1c of -3.7%±1.7%. This combination therapy was generally well tolerated with most adverse events being of mild or moderate intensity; asymptomatic hypoglycemia was reported by just 1 of 66 (1.5%) patients. These findings provide evidence in support of linagliptin plus metformin as a well-tolerated and effective treatment alternative to insulin for new-onset patients with T2DM and severe hyperglycemia.


Petrak F.,Ruhr University Bochum | Herpertz S.,Ruhr University Bochum | Albus C.,University of Cologne | Hermanns N.,Diabetes Center Mergentheim | And 7 more authors.
BMC Psychiatry | Year: 2013

Background: Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes.Methods/Design: This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50-200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase.Discussion: The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression.The study is investigator initiated and was supported by the 'Förderprogramm Klinische Studien (Clinical Trials)' and the 'Competence Network for Diabetes mellitus' funded by the Federal Ministry of Education and Research (FKZ 01KG0505). © 2013 Petrak et al.; licensee BioMed Central Ltd.


Haak T.,Diabetes Center Mergentheim | Meinicke T.,Boehringer Ingelheim | Jones R.,Boehringer Ingelheim | Weber S.,Boehringer Ingelheim | And 2 more authors.
International Journal of Clinical Practice | Year: 2013

Objective: To determine the efficacy and safety of linagliptin in initial combination with metformin in patients with type 2 diabetes. Methods: This 1-year randomised, double-blind study was an extension of a 6-month randomised controlled trial, in which adults with type 2 diabetes received one of six treatment regimens (linagliptin 2.5 mg plus metformin 500 mg bid, linagliptin 2.5 mg plus metformin mg 1000 bid, metformin 1000 mg bid, metformin 500 mg bid, linagliptin 5 mg qd or placebo). In the extension, patients in the first three treatment groups continued their regimen (non-switched group, n = 333) while the metformin 500 mg bid, linagliptin 5 mg qd and placebo groups were re-randomised to one of the three continuing regimens (switched group, n = 233). Results: All three non-switched groups maintained reductions in glycosylated haemoglobin (HbA1c; mean ± standard deviation reductions across the 1.5-year period: linagliptin 2.5 plus metformin 1000 bid, -1.63 ± 1.05%; linagliptin 2.5 plus metformin 500 bid, -1.32 ± 1.06%; metformin 1000 bid, -1.25 ± 0.91%) while the switched groups showed additional HbA1c reductions. During the extension, there were no clinically meaningful changes in body weight in any group. Adverse event rates were similar between groups, with most events being mild or moderate, and the incidence of investigator-defined hypoglycaemia was low, with no severe events. Discussion: Initial combination of linagliptin and metformin was well tolerated over the 1-year extension period, with low risk of hypoglycaemia, and improved glycaemic control vs. metformin alone. Conclusion: The initial combination of linagliptin and metformin appears to provide a useful treatment option in patients whose blood glucose levels are increased to an extent that metformin monotherapy may not achieve treatment targets. © 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.


Haak T.,Diabetes Center Mergentheim | Meinicke T.,Boehringer Ingelheim | Jones R.,Boehringer Ingelheim | Weber S.,Boehringer Ingelheim | And 2 more authors.
Diabetes, Obesity and Metabolism | Year: 2012

Aims: To evaluate the efficacy and safety of initial combination therapy with linagliptin plus metformin versus linagliptin or metformin monotherapy in patients with type 2 diabetes. Methods: In this 24-week, double-blind, placebo-controlled, Phase III trial, 791 patients were randomized to one of six treatment arms. Two free combination therapy arms received linagliptin 2.5 mg twice daily (bid) + either low (500 mg) or high (1000 mg) dose metformin bid. Four monotherapy arms received linagliptin 5 mg once daily, metformin 500 mg or 1000 mg bid or placebo. Patients with haemoglobin A1c (HbA1c) ≥11.0% were not eligible for randomization and received open-label linagliptin + high-dose metformin. Results: The placebo-corrected mean (95% confidence interval) change in HbA1c from baseline (8.7%) to week 24 was -1.7% (-2.0, -1.4) for linagliptin + high-dose metformin, -1.3% (-1.6, -1.1) for linagliptin + low-dose metformin, -1.2% (-1.5, -0.9) for high-dose metformin, -0.8% (-1.0, -0.5) for low-dose metformin and -0.6 (-0.9, -0.3) for linagliptin (all p < 0.0001). In the open-label arm, the mean change in HbA1c from baseline (11.8%) was -3.7%. Hypoglycaemia occurred at a similar low rate with linagliptin + metformin (1.7%) as with metformin alone (2.4%). Adverse event rates were comparable across treatment arms. No clinically significant changes in body weight were noted. Conclusions: Initial combination therapy with linagliptin plus metformin was superior to metformin monotherapy in improving glycaemic control, with a similar safety and tolerability profile, no weight gain and a low risk of hypoglycaemia. © 2012 Blackwell Publishing Ltd.


Making appropriate treatment decisions for patients newly diagnosed with type 2 diabetes mellitus (T2DM) and severe hyperglycemia (glycated hemoglobin [HbA1c] >10% or fasting plasma glucose ≥250 mg/dL) presents a formidable challenge to primary care physicians. Extreme defects in insulin secretion make it unlikely that these patients will achieve glycemic targets with metformin monotherapy. Additionally, uncontrolled hyperglycemia is associated with an increased risk of short-term acute complications, such as hyperosmolar coma, and long-term complications affecting the micro- and macrovasculature. Thus, severely hyperglycemic patients require prompt, intensive treatment to re-establish glycemic control. Current guidelines indicate that either initial insulin therapy or initial combination therapy with metformin plus non-insulin drug(s) are the treatments of choice for these challenging-to-treat patients. This mini-review examines the clinical evidence supporting these two treatment options, with particular reference to the findings of a phase 3 study of treatment with an initial combination of metformin plus the dipeptidyl peptidase-4 inhibitor, linagliptin. Intensive insulin therapy can induce sustained euglycemia and improve beta-cell function in newly diagnosed patients. However, insulin use is associated with an increased risk of adverse events, such as hypoglycemia and weight gain. These potentially serious side effects cause concern among patients and physicians, and are a major barrier to initiating and maintaining adherence to insulin treatment. In the phase 3 study, open-label treatment of severely hyperglycemic patients (HbA1c ≥11.0%) with linagliptin plus metformin resulted in a mean change in HbA1c of -3.7% ± 1.7%. This combination therapy was generally well tolerated with most adverse events being of mild or moderate intensity; asymptomatic hypoglycemia was reported by just 1 of 66 (1.5%) patients. These findings provide evidence in support of linagliptin plus metformin as a well-tolerated and effective treatment alternative to insulin for new-onset patients with T2DM and severe hyperglycemia. © 2012 Springer Healthcare.

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