Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study.

AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS: To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. RESULTS: Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION: This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.

[Which patients from routine care use the new insulin analogue glargine U300 compared to patients with glargine U100 : A multicenter analysis of 14,123 patients with insulin glargine from die diabetes registries DPV and DIVE]. / Welche Patienten aus der Routinebetreuung verwenden das neue Insulin-Analogon Glargin U300 im Vergleich zu Patienten mit Glargin U100? : Eine multizentrische Analyse von 14.123 Patienten mit Insulin Glargin aus den Diabetesregistern DPV und DIVE.

BACKGROUND: Glargine U300 (Gla-300) is a further development of glargine U100 (Gla-100). Since 2015, Gla-300 has been available in Germany and Austria. We compared patients initiating therapy with Gla-300 with patients starting with Gla-100. Moreover, it was investigated whether patients from real-life diabetes care differ from patients participating in the EDITION clinical study program. METHODS: Data are based on the diabetes registries DPV and DIVE. Patients started/switched to Gla-100 or Gla-300 in 2015 were included. Linear regression was applied for bodyweight (BW), BMI, HbA1C, daily total and basal insulin dose/kgBW and negative binomial regression for severe hypoglycemia. Data were adjusted for age, sex, and diabetes duration. RESULTS: 14,123 patients were identified (Gla-100: 11,397; Gla-300: 2726). Gla-300 patients with T1D were older, T2D patients younger compared to subjects using Gla-100 (both p < 0.0001). In Gla-300 subjects, diabetes duration was longer (both p < 0.0001). Patients started/switched to Gla-300 had a higher BW, a higher BMI and a lower baseline HbA1C. The rate of severe hypoglycemia was comparable. Total and basal insulin doses/kgBW were higher in patients with Gla-300. DPV/DIVE subjects were older, had a lower BW, and were more frequently male compared to EDITION patients. HbA1C was higher in T1D patients from DPV/DIVE. CONCLUSION: Data from the diabetes registries DPV/DIVE indicate differences between Gla-300 and Gla-100 patients at the onset of insulin therapy. This analysis provides additional information to the EDITION clinical study program.

Renal Complications and Duration of Diabetes: An International Comparison in Persons with Type 1 Diabetes.

INTRODUCTION: Renal complications are both a marker of previous suboptimal glycaemic control and a major risk factor for cardiovascular disease in persons with type 1 diabetes (T1D). The aim of the study was to evaluate the prevalence of renal complications in persons with T1D in four geographical regions. METHODS: Nationwide registry data from Austria/Germany, Sweden and the US were used to estimate the prevalence of renal complications from January 2016 until September 2018. Chronic kidney disease (CKD) and albuminuria in the study population and each registry were analysed by diabetes duration. Risk factors for renal complications were described by registry. RESULTS: In the total cohort of 78.926 adults with T1D, mean age was 44.4 ± 18.43 years and mean diabetes duration was 21.6 ± 22 years. Mean estimated glomerular filtration rate (eGFR) was 94.0 ± 31.45 ml/min, 13.0% had microalbuminuria and 3.9% had macroalbuminuria. Mean age, diabetes duration, use of insulin pumps and continuous glucose monitoring, as well as presence of albuminuria, varied between registries. Albuminuria was present in approximately 10% of persons with diabetes duration < 20 years and impaired renal function (eGFR < 60 ml/min) was present in 17%. In persons with diabetes duration > 40 years, approximately one-third had albuminuria and 25% had impaired renal function. CONCLUSIONS: This analysis used three nationwide registries of persons with T1D. Despite recent use of more effective diabetes therapies, a substantial proportion of persons with T1D have renal complications at < 20 years after diagnosis. Efficient glucose-lowering and renal-protective strategies are needed in persons with T1D.

DIVE/DPV registries: benefits and risks of analog insulin use in individuals 75 years and older with type 2 diabetes mellitus.

INTRODUCTION: The aims of this study were to characterize insulin-treated individuals aged ≥75 years with type 2 diabetes using basal insulin analogs (BIA) or regular insulins (human insulin (HI)/neutral protamine Hagedorn (NPH)) and to compare the benefits and risks. RESEARCH DESIGN AND METHODS: The analysis was based on data from the DPV (Diabetes-Patienten-Verlaufsdokumentation) and DIVE (DIabetes Versorgungs-Evaluation) registries. To balance for confounders, propensity score matching for age, sex, diabetes duration, body mass index and hemoglobin A1c (HbA1c) as covariates was performed. RESULTS: Among 167 300 patients aged ≥75 years with type 2 diabetes (mean age, 80.3 years), 9601 subjects used insulin regimens with basal insulin (HI/NPH or BIA). Of these 8022 propensity score-matched subjects were identified. The mean diabetes duration was ~12 years and half of the patients were male. At the time of switch, patients provided with BIA experienced more dyslipidemia (89.3% vs 85.9%; p=0.002) and took a greater number of medications (4.3 vs 3.7; p<0.001) and depression was more prevalent (8.4% vs 6.5%; p=0.01). Aggregated to the most actual treatment year, BIA was associated with a higher percentage of patients using basal-supported oral therapy (42.6% vs 14.4%) and intensified conventional insulin therapy (44.3% vs 29.4%) and lower total daily insulin doses (0.24 IU/kg/day vs 0.30 IU/kg/day; p<0.001). The study did not reveal significant differences in efficacy (HbA1c 7.4% vs 7.3%; p=0.06), hospitalizations (0.7 vs 0.8 per patient-year (PY); p=0.15), length of stay (16.3 vs 16.1 days per PY; p=0.53), or rates of severe hypoglycemia (4.07 vs 4.40 per 100 PY; p=0.88), hypoglycemia with coma (3.64 vs 3.26 per 100 PY; p=0.88) and diabetic ketoacidosis (0.01 vs 0.03 per 100 PY; p=0.36). CONCLUSION: BIA were used in more individually and patient-centered therapy regimens compared with HI/NPH in patients with a mean age of 80 years. Both groups were slightly overtreated with mean HbA1c <7.5%. The risk of severe hypoglycemia was low and independent of insulin type. Further analyses of elderly patients with type 2 diabetes are needed to provide evidence for best practice approaches in this age group.

Comparative Characteristics of Patients with Type 2 Diabetes Mellitus Treated by Bariatric Surgery Versus Medical Treatment: a Multicentre Analysis of 277,862 Patients from the German/Austrian DPV Database.

INTRODUCTION: Bariatric surgery is a well-established treatment option for serious obesity and concomitant type 2 diabetes mellitus (T2DM). In this analysis, we investigated predictors for bariatric surgery in everyday clinical practice. MATERIALS AND METHODS: In the DPV-registry, patients with T2DM from Germany and Austria treated by bariatric surgery were compared to non-surgery controls by descriptive statistics and regression analysis. RESULTS: Among 277,862 patients with T2DM, 0.07% underwent bariatric surgery. Surgery patients were predominantly female [61.20%], younger [median age (Q1;Q3) 54.74(47.40;61.61) vs. 70.04 (60.36;77.58) years] and had a longer diabetes duration [11.21 (7.15;17.93) vs. 8.36 (2.94;14.91) years]. They had a higher BMI [40.02 vs. 30.61 kg/m2, adjusted p < 0.0001] and a slightly lower HbA1c [7.25 vs. 7.56%, adjusted p < 0.05]. There was a trend using more often insulin therapy (52.79 vs.50.08%, n.s.) with no difference in insulin dose/kg × day [0.56 vs. 0.58, n.s.]. Sleeve gastrectomy was performed most frequently, followed by Roux-en-Y gastric bypass, gastric banding, gastric balloon and others. A 2-year follow-up data in 29 patients demonstrated significant reductions in BMI [45.23 to 38.00 kg/m2, p < 0.005] and HbA1c [7.98 to 6.98%, p < 0.005], and a trend for reduced insulin requirements [62.07 vs. 44.83%, n.s.]. CONCLUSION: Despite favourable 2-year outcomes, bariatric surgery is still used rarely in patients with T2DM and obesity. BMI rather than metabolic control seems to represent the major selector for or against bariatric surgery in T2DM.

Female sex, young age, northern German residence, hypoglycemia and disabling diabetes complications are associated with depressed mood in the WHO-5 questionnaire - A multicenter DPV study among 17,563 adult patients with type 2 diabetes.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. LIMITATION: Due to the cross-sectional design, no causality can be drawn. CONCLUSIONS: 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.

Risk Factors for Retinopathy and DME in Type 2 Diabetes-Results from the German/Austrian DPV Database.

To assess the prevalence and risk factors for early and severe diabetic retinopathy and macular edema in a large cohort of patients with type 2 diabetes Retinopathy grading (any retinopathy, severe retinopathy, diabetic macular edema) and risk factors of 64784 were prospectively recorded between January 2000 and March 2013 and analyzed by Kaplan-Meier analysis and logistic regression. Retinopathy was present in 20.12% of subjects, maculopathy was found in 0.77%. HbA1c > 8%, microalbuminuria, hypertension, BMI > 35 kg/m2 and male sex were significantly associated with any retinopathy, while HbA1c and micro- and macroalbuminuria were the strongest risk predictors for severe retinopathy. Presence of macroalbuminuria increased the risk for DME by 177%. Retinopathy remains a significant clinical problem in patients with type 2 diabetes. Metabolic control and blood pressure are relevant factors amenable to treatment. Concomitant kidney disease identifies high risk patients and should be emphasized in interdisciplinary communication.