Research Institute Diabetes Academy Mergentheim FIDAM

Bad Mergentheim, Germany

Research Institute Diabetes Academy Mergentheim FIDAM

Bad Mergentheim, Germany
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Bergis D.,Goethe University Frankfurt | Bergis P.M.,Research Institute Diabetes Academy Mergentheim FIDAM | Hermanns N.,Research Institute Diabetes Academy Mergentheim FIDAM | Hermanns N.,University of Bamberg | And 5 more authors.
Acta Diabetologica | Year: 2014

Aims: Charcot neuro-osteoarthropathy (CN) is a rare complication of diabetic foot syndrome associated with chronic inflammation of the foot and severe, limb-threatening musculoskeletal deformities. Aim of this study was to investigate patients with CN for comorbidities, amputations, ulcers, secondary diseases and mortality.Methods: The study was conducted at a specialized German hospital for patients with diabetes. One-hundred and eleven patients were enrolled, and their course was followed over a period of 15 years. Association of CN with comorbidity, foot ulcers, amputations and mortality was assessed. Clinical course of patients was followed using two standardized questionnaires.Results: Presence of CN was significantly associated with diabetic retinopathy (p = 0.047), plantar (p < 0.001), tarsal (p = 0.032) and middle-foot ulcers (p = 0.01). A significant correlation between the presence of CN and a history of amputations was seen (p = 0.022). Patients were at increased risk to suffer from subsequent amputations during follow-up when micro- and macrovascular comorbidities such as retinopathy (p = 0.01) and peripheral artery disease (p < 0.001) were present. Additionally, coronary artery disease (CHD) was identified as an independent predictor of mortality in the cohort of this study (OR 6.192, 95 % CI 1.155–33.208, p = 0.033). Median overall survival of patients with CN and CHD was significantly shorter than OS of patients without CHD (7.8 vs. 13.1 years, p = 0.0045, HR 2.8437, 95 % CI 0.9818–8.2364).Conclusions: In our study, CHD was the most important factor of survival in CN patients. For optimal management of CN, adequate diagnostics and treatment of CHD according to current guidelines should be considered. © 2014, Springer-Verlag Italia.


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.


Hermanns N.,Research Institute Diabetes Academy Mergentheim FIDAM | Lilly L.C.,CeQur Corporation | Mader J.K.,Medical University of Graz | Aberer F.,Medical University of Graz | And 4 more authors.
Journal of Diabetes Science and Technology | Year: 2015

Background: The PaQ® insulin delivery system is a simple-to-use patch-on device that provides preset basal rates and bolus insulin on demand. In addition to feasibility of use, safety, and efficacy (reported elsewhere), this study analyzed the impact of PaQ on patient-reported outcomes, including barriers to insulin treatment, diabetes-related distress, and attitudes toward insulin therapy in patients with type 2 diabetes on a stable multiple daily injection (MDI) regimen. Methods: This single-center, open-label, single-arm study comprised three 2-week periods: baseline (MDI), transition from MDI to PaQ, and PaQ treatment. Validated questionnaires were administered during the baseline and PaQ treatment periods: Barriers to Insulin Treatment questionnaire (BIT), Insulin Treatment Appraisal Scale (ITAS), and Problem Areas in Diabetes scale (PAID). Results: Eighteen patients (age 59 ± 5 years, diabetes duration 15 ± 7 years, 21% female, HbA1c 7.7 ± 0.7%) completed the questionnaires. There was a strong, significant effect of PaQ use in mean BIT total scores (difference [D] =-5.4 ± 0.7.7, P =.01, effect size [d] = 0.70). Patients perceived less stigmatization by insulin injection (D =-2.2 ± 6.2, P =.18, d = 0.35), increased positive outcome (D = 1.9 ± 6.6, P =.17, d = 0.29), and less fear of injections (1.3 ± 4.8, P =.55, d = 0.28). Mean change in ITAS scores after PaQ device use showed a nonsignificant improvement of 1.71 ± 5.63 but moderate effect size (d = 0.30, P =.14). No increase in PAID scores was seen. Conclusions: The results and moderate to large effects sizes suggest that PaQ device use has beneficial and clinically relevant effects to overcoming barriers to and negative appraisal of insulin treatment, without increasing other diabetes-related distress. © 2015 Diabetes Technology Society Reprints and permissions.


Hermanns N.,Research Institute Diabetes Academy Mergentheim FIDAM | Hermanns N.,Diabetes Center Mergentheim | Schumann B.,Diabetes Center Mergentheim | Kulzer B.,Research Institute Diabetes Academy Mergentheim FIDAM | And 3 more authors.
Journal of Diabetes Science and Technology | Year: 2014

In a randomized crossover trial the impact of continuous glucose monitoring (CGM) was tested on the occurrence of low blood glucose values measured by point of care (POC) measurement and on low glucose values measured by CGM in the interstitial fluid. A total of 41 type 1 diabetic patients (age 42.0 ± 11.4 years, diabetes duration 15.3 ± 10.1 years, A1c 8.2 ± 1.4%) used a CGM system (Dexcom SEVEN PLUS system) twice. In first study phase (CGM blind), patients were blind regarding the CGM current glucose levels and were not alerted when critical glucose values were reached. In the second phase (CGM real time), patients had access to current glucose levels and were alerted if critical glucose values were reached. During CGM real time the proportion of hypoglycemic POC blood glucose values were significantly reduced (7.5 ± 5.6% vs 10.1 ± 7.5%; P = .04), whereas the proportion of euglycemic blood glucose values were significantly enhanced (73.7 ± 18.3% vs 68.3 ± 12.1%; P = .01). The duration of low glucose periods in the interstitial fluid was significantly lower in the CGM real time phase (125 ± 89 vs 181 ± 125 minutes per day; P = .005). The time until a low blood glucose was detected by POC measurement was shortened by 33.2 ± 76.1 minutes (P = .03). The study demonstrated that CGM is able to not only reduce duration of hypoglycemia measured by CGM in interstitial fluid, but also reduce the proportion of low POC blood glucose measurements. In addition, hypoglycemia can be detected earlier. © 2014 Diabetes Technology Society.


PubMed | Medical University of Graz, Research Institute Diabetes Academy Mergentheim FIDAM and CeQur Corporation
Type: Clinical Trial | Journal: Journal of diabetes science and technology | Year: 2015

The PaQ insulin delivery system is a simple-to-use patch-on device that provides preset basal rates and bolus insulin on demand. In addition to feasibility of use, safety, and efficacy (reported elsewhere), this study analyzed the impact of PaQ on patient-reported outcomes, including barriers to insulin treatment, diabetes-related distress, and attitudes toward insulin therapy in patients with type 2 diabetes on a stable multiple daily injection (MDI) regimen.This single-center, open-label, single-arm study comprised three 2-week periods: baseline (MDI), transition from MDI to PaQ, and PaQ treatment. Validated questionnaires were administered during the baseline and PaQ treatment periods: Barriers to Insulin Treatment questionnaire (BIT), Insulin Treatment Appraisal Scale (ITAS), and Problem Areas in Diabetes scale (PAID).Eighteen patients (age 59 5 years, diabetes duration 15 7 years, 21% female, HbA1c 7.7 0.7%) completed the questionnaires. There was a strong, significant effect of PaQ use in mean BIT total scores (difference [D] = -5.4 0.7.7, P = .01, effect size [d] = 0.70). Patients perceived less stigmatization by insulin injection (D = -2.2 6.2, P = .18, d = 0.35), increased positive outcome (D = 1.9 6.6, P = .17, d = 0.29), and less fear of injections (1.3 4.8, P = .55, d = 0.28). Mean change in ITAS scores after PaQ device use showed a nonsignificant improvement of 1.71 5.63 but moderate effect size (d = 0.30, P = .14). No increase in PAID scores was seen.The results and moderate to large effects sizes suggest that PaQ device use has beneficial and clinically relevant effects to overcoming barriers to and negative appraisal of insulin treatment, without increasing other diabetes-related distress.


Snoek F.J.,VU University Amsterdam | Bremmer M.A.,VU University Amsterdam | Hermanns N.,Research Institute Diabetes Academy Mergentheim FIDAM
The Lancet Diabetes and Endocrinology | Year: 2015

Depression presents in roughly 20% of people with diabetes worldwide, and adversely affects quality of life and treatment outcomes. The causes of depression in diabetes are poorly understood, but research suggests a bi-directional association, at least for type 2 diabetes. Inconsistent findings regarding prevalence and depression treatment outcomes in patients with diabetes seem partly attributable to inconsistencies in the definition and measurement of depression and in distinguishing it from diabetes-distress, a psychological concept related to depression. We review evidence suggesting that diabetes-distress and depression are correlated and overlapping constructs, but are not interchangeable. Importantly, diabetes-distress seems to mediate the association between depression and glycaemic control. We propose a model to explain the direct and indirect effects of depression and diabetes-distress on glycaemic control. Additionally, using emerging insights from data-driven approaches, we suggest three distinct symptom profiles to define depression in patients with diabetes that could help explain differential associations between depression and metabolic abnormalities, and to tailor interventions for depression. Future research should focus on further refining depression profiles in patients with diabetes, taking into account the natural history of diabetes and depression, clinical characteristics, and diabetes-distress. The assessment of diabetes-distress and depression in research and clinical practice will be essential to identify high-risk patients with different mental health needs. © 2015 Elsevier Ltd.


PubMed | Research Institute Diabetes Academy Mergentheim FIDAM and Insuline Medical
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2014

The InsuPad is a medical device to accelerate insulin resorption by applying local heat at the insulin injection site. This crossover study examined the impact of the InsuPad use on postprandial glucose excursions under daily life conditions. In 1 study phase, diabetic patients used the InsuPad when injecting bolus insulin before breakfast and dinner and measured their blood glucose 5 times daily (before breakfast, lunch, and dinner and after breakfast and dinner). In the other study phase, blood glucose measurements were maintained without using the InsuPad. The order of the study phases was randomized. Twenty patients with a high insulin demand took part (30% type 1 diabetes, age 53.7 8.9 years, diabetes duration 14.9 7.4 years; HbA1c 8.3 0.8%; total daily insulin demand 0.97 0.32 IU per kg). Postprandial glucose excursion was reduced by 15.4 mg/dl (95% CI 9.7-21.2 mg/dl; P = .011) after breakfast and dinner if InsuPad was used. The mean blood glucose was lower by 8.8 mg/dl (95% CI 0:3-18:0 mg/dl; P = .099) when using the InsuPad. Safety parameters and the percentage of hypoglycemic (< 60 mg/dl) or hyperglycemic (> 300 mg/dl) blood glucose measurements were not negatively affected by InsuPad use (hypoglycemic values 1.4% vs 1.5%, P = .961; hyperglycemic values 2.6% vs 4.0%, P = .098). Local heating of the insulin injection site by use of the InsuPad device is an effective and safe method to reduce postprandial blood glucose excursions under daily life conditions without negative side effects on the occurrence of low or high blood glucose values.


PubMed | VU University Amsterdam and Research Institute Diabetes Academy Mergentheim FIDAM
Type: Journal Article | Journal: The lancet. Diabetes & endocrinology | Year: 2015

Depression presents in roughly 20% of people with diabetes worldwide, and adversely affects quality of life and treatment outcomes. The causes of depression in diabetes are poorly understood, but research suggests a bi-directional association, at least for type 2 diabetes. Inconsistent findings regarding prevalence and depression treatment outcomes in patients with diabetes seem partly attributable to inconsistencies in the definition and measurement of depression and in distinguishing it from diabetes-distress, a psychological concept related to depression. We review evidence suggesting that diabetes-distress and depression are correlated and overlapping constructs, but are not interchangeable. Importantly, diabetes-distress seems to mediate the association between depression and glycaemic control. We propose a model to explain the direct and indirect effects of depression and diabetes-distress on glycaemic control. Additionally, using emerging insights from data-driven approaches, we suggest three distinct symptom profiles to define depression in patients with diabetes that could help explain differential associations between depression and metabolic abnormalities, and to tailor interventions for depression. Future research should focus on further refining depression profiles in patients with diabetes, taking into account the natural history of diabetes and depression, clinical characteristics, and diabetes-distress. The assessment of diabetes-distress and depression in research and clinical practice will be essential to identify high-risk patients with different mental health needs.

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