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

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          Abstract

          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.

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          Most cited references41

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          Sarcopenia: revised European consensus on definition and diagnosis

          Abstract Background in 2010, the European Working Group on Sarcopenia in Older People (EWGSOP) published a sarcopenia definition that aimed to foster advances in identifying and caring for people with sarcopenia. In early 2018, the Working Group met again (EWGSOP2) to update the original definition in order to reflect scientific and clinical evidence that has built over the last decade. This paper presents our updated findings. Objectives to increase consistency of research design, clinical diagnoses and ultimately, care for people with sarcopenia. Recommendations sarcopenia is a muscle disease (muscle failure) rooted in adverse muscle changes that accrue across a lifetime; sarcopenia is common among adults of older age but can also occur earlier in life. In this updated consensus paper on sarcopenia, EWGSOP2: (1) focuses on low muscle strength as a key characteristic of sarcopenia, uses detection of low muscle quantity and quality to confirm the sarcopenia diagnosis, and identifies poor physical performance as indicative of severe sarcopenia; (2) updates the clinical algorithm that can be used for sarcopenia case-finding, diagnosis and confirmation, and severity determination and (3) provides clear cut-off points for measurements of variables that identify and characterise sarcopenia. Conclusions EWGSOP2's updated recommendations aim to increase awareness of sarcopenia and its risk. With these new recommendations, EWGSOP2 calls for healthcare professionals who treat patients at risk for sarcopenia to take actions that will promote early detection and treatment. We also encourage more research in the field of sarcopenia in order to prevent or delay adverse health outcomes that incur a heavy burden for patients and healthcare systems.
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            An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

            The propensity score is the probability of treatment assignment conditional on observed baseline characteristics. The propensity score allows one to design and analyze an observational (nonrandomized) study so that it mimics some of the particular characteristics of a randomized controlled trial. In particular, the propensity score is a balancing score: conditional on the propensity score, the distribution of observed baseline covariates will be similar between treated and untreated subjects. I describe 4 different propensity score methods: matching on the propensity score, stratification on the propensity score, inverse probability of treatment weighting using the propensity score, and covariate adjustment using the propensity score. I describe balance diagnostics for examining whether the propensity score model has been adequately specified. Furthermore, I discuss differences between regression-based methods and propensity score-based methods for the analysis of observational data. I describe different causal average treatment effects and their relationship with propensity score analyses.
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              2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD

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                Author and article information

                Journal
                BMJ Open Diabetes Res Care
                BMJ Open Diabetes Res Care
                bmjdrc
                bmjdrc
                BMJ Open Diabetes Research & Care
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2052-4897
                2021
                3 June 2021
                : 9
                : 1
                : e002215
                Affiliations
                [1 ]Institute for Pharmacology and Preventive Medicine , Cloppenburg, Germany
                [2 ]departmentInstitute of Epidemiology and Medical Biometry, ZIBMT , University of Ulm , Ulm, Germany
                [3 ]German Center for Diabetes Research (DZD) , München-Neuherberg, Germany
                [4 ]departmentDepartment of Internal Medicine , Knappschaftskrankenhaus Bottrop , Bottrop, Germany
                [5 ]Center for Diabetes Ludwigsburg , Ludwigsburg, Germany
                [6 ]Specialized Diabetes Practice Berlin Tempelhof , Berlin, Germany
                [7 ]Medical Practice for Internal Medicine and Diabetology Rhein-Sieg , Niederkassel-Rheidt, Germany
                [8 ]departmentDepartment of Internal Medicine I , Martin-Luther-University Halle-Wittenberg, University Medicine, Academic Hospital Paul-Gerhardt-Stift , Lutherstadt Wittenberg, Germany
                [9 ]Medical Practice for Internal Medicine Rottweil , Rottweil, Germany
                Author notes
                [Correspondence to ] Professor Peter Bramlage; peter.bramlage@ 123456ippmed.de
                Author information
                http://orcid.org/0000-0003-4970-2110
                Article
                bmjdrc-2021-002215
                10.1136/bmjdrc-2021-002215
                8183199
                34083247
                e06caef6-c263-4d5f-a491-5576a35d3800
                © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 14 February 2021
                : 24 March 2021
                : 28 March 2021
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004326, Bayer;
                Award ID: N/A
                Funded by: FundRef http://dx.doi.org/10.13039/100004339, Sanofi;
                Award ID: N/A
                Funded by: German Centre for Diabetes Research;
                Award ID: 82DZD14A02
                Funded by: FundRef http://dx.doi.org/10.13039/100004325, AstraZeneca;
                Award ID: N/A
                Funded by: Abbott;
                Award ID: N/A
                Funded by: FundRef http://dx.doi.org/10.13039/100001003, Boehringer Ingelheim;
                Award ID: N/A
                Funded by: European Foundation for the Study of Diabetes (EFSD);
                Award ID: N/A
                Funded by: German Diabetes Society;
                Award ID: N/A
                Categories
                Clinical care/Education/Nutrition
                1506
                1866
                Custom metadata
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                type 2 diabetes,insulin analogs,elderly,hypoglycemia
                type 2 diabetes, insulin analogs, elderly, hypoglycemia

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