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      International Consensus on Risk Management of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Treated With Sodium–Glucose Cotransporter (SGLT) Inhibitors

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          Abstract

          Sodium–glucose cotransporter (SGLT) inhibitors are new oral antidiabetes medications shown to effectively reduce glycated hemoglobin (A1C) and glycemic variability, blood pressure, and body weight without intrinsic properties to cause hypoglycemia in people with type 1 diabetes. However, recent studies, particularly in individuals with type 1 diabetes, have demonstrated increases in the absolute risk of diabetic ketoacidosis (DKA). Some cases presented with near-normal blood glucose levels or mild hyperglycemia, complicating the recognition/diagnosis of DKA and potentially delaying treatment. Several SGLT inhibitors are currently under review by the U.S. Food and Drug Administration and European regulatory agencies as adjuncts to insulin therapy in people with type 1 diabetes. Strategies must be developed and disseminated to the medical community to mitigate the associated DKA risk. This Consensus Report reviews current data regarding SGLT inhibitor use and provides recommendations to enhance the safety of SGLT inhibitors in people with type 1 diabetes.

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          Euglycemic Diabetic Ketoacidosis: A Potential Complication of Treatment With Sodium–Glucose Cotransporter 2 Inhibition

          OBJECTIVE Sodium–glucose cotransporter 2 (SGLT-2) inhibitors are the most recently approved antihyperglycemic medications. We sought to describe their association with euglycemic diabetic ketoacidosis (euDKA) in hopes that it will enhance recognition of this potentially life-threatening complication. RESEARCH DESIGN AND METHODS Cases identified incidentally are described. RESULTS We identified 13 episodes of SGLT-2 inhibitor–associated euDKA or ketosis in nine individuals, seven with type 1 diabetes and two with type 2 diabetes, from various practices across the U.S. The absence of significant hyperglycemia in these patients delayed recognition of the emergent nature of the problem by patients and providers. CONCLUSIONS SGLT-2 inhibitors seem to be associated with euglycemic DKA and ketosis, perhaps as a consequence of their noninsulin-dependent glucose clearance, hyperglucagonemia, and volume depletion. Patients with type 1 or type 2 diabetes who experience nausea, vomiting, or malaise or develop a metabolic acidosis in the setting of SGLT-2 inhibitor therapy should be promptly evaluated for the presence of urine and/or serum ketones. SGLT-2 inhibitors should only be used with great caution, extensive counseling, and close monitoring in the setting of type 1 diabetes.
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            Euglycemic Diabetic Ketoacidosis: A Predictable, Detectable, and Preventable Safety Concern With SGLT2 Inhibitors.

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              Assessment of diabetes-related distress.

              To describe a new measure of psychosocial adjustment specific to diabetes, the Problem Areas in Diabetes Survey (PAID), and to present initial information on its reliability and validity. Before their routine clinic appointments, 451 female patients with type I and type II diabetes, all of whom required insulin, completed a self-report survey. Included in the survey was the PAID, a 20-item questionnaire in which each item represents a unique area of diabetes-related psychosocial distress. Each item is rated on a six-point Likert scale, reflecting the degree to which the item is perceived as currently problematic. A total scale score, hypothesized to reflect the overall level of diabetes-related emotional distress, is computed by summing the total item responses. To examine the concurrent validity of the PAID, the survey also included a series of standardized questionnaires assessing psychosocial functioning (general emotional distress, fear of hypoglycemia, and disordered eating), attitudes toward diabetes, and self-care behaviors. All subjects were assessed for HbA1, within 30 days of survey completion and again approximately 1-2 years later. Finally, long-term diabetic complications were determined through chart review. Internal reliability of the PAID was high, with good item-to-total correlations. Approximately 60% of the subject sample reported at least one serious diabetes-related concern. As expected, the PAID was positively associated with relevant psychosocial measures of distress, including general emotional distress, disordered eating, and fear of hypoglycemia, short- and long-term diabetic complications, and HbA1, and negatively associated with reported self-care behaviors. The PAID accounted for approximately 9% of the variance in HbA1. Diabetes-related emotional distress, as measured by the PAID, was found to be a unique contributor to adherence to self-care behaviors after adjustment for age, diabetes duration, and general emotional distress. In addition, the PAID was associated with HbA1 even after adjustment for age, diabetes duration, general emotional distress, and adherence to self-care behaviors. These findings suggest that the PAID, a brief, easy-to-administer instrument, may be valuable in assessing psychosocial adjustment to diabetes. In addition to high internal reliability, the consistent pattern of correlational findings indicates that the PAID is tapping into relevant aspects of emotional distress and that its particular feature, the measurement of diabetes-related emotional distress, is uniquely associated with diabetes-relevant outcomes. These data are also consistent with the hypothesis that diabetes-related emotional distress, separate from general emotional distress, is an independent and major contributor to poor adherence. Given that the study was limited to female patients using insulin, further examination of the clinical usefulness of the PAID will need to focus on more heterogeneous samples.
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                Author and article information

                Journal
                Diabetes Care
                Diabetes Care
                diacare
                dcare
                Diabetes Care
                Diabetes Care
                American Diabetes Association
                0149-5992
                1935-5548
                June 2019
                06 February 2019
                : 42
                : 6
                : 1147-1154
                Affiliations
                [1] 1Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany
                [2] 2University of Colorado Denver and Barbara Davis Center for Diabetes, Aurora, CO
                [3] 3Keck School of Medicine of the University of Southern California, Los Angeles, CA
                [4] 4University of North Carolina School of Medicine, Chapel Hill, NC
                [5] 5Department of Endocrinology, UZ Gasthuisberg, KU Leuven, Leuven, Belgium
                [6] 6Division of Endocrinology and Metabolism, Department of Medicine, University of California, San Diego, San Diego, CA
                [7] 7Alexander Associates LLC, Gwynedd Valley, PA
                [8] 8Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children’s Hospital, University Medical Centre Ljubljana, and Faculty of Medicine, University of Ljubljana, Slovenia
                [9] 9Clinic University Hospital of Valencia, Valencia, Spain
                [10] 10Atlanta Diabetes Associates, Atlanta, GA
                [11] 11Clinique d'endocrinologie, L'institut du thorax, CHU Nantes, CIC 1413 INSERM, Nantes, France
                [12] 12The diaTribe Foundation, San Francisco, CA
                [13] 13Division of Endocrinology, Diabetes and Metabolism, University at Buffalo, The State University of New York, Buffalo, NY
                [14] 14JDRF International, New York, NY
                [15] 15National Research Council (CNR) Institute of Clinical Physiology, Pisa, Italy
                [16] 16Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Australia
                [17] 17Grunberger Diabetes Institute, Bloomfield Hills, MI
                [18] 18Academic Unit of Diabetes, Endocrinology & Metabolism, University of Sheffield, Sheffield, U.K.
                [19] 19Close Concerns, San Francisco, CA
                [20] 20McNair Interests, Houston, TX
                [21] 21Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel
                [22] 22Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
                [23] 23CGParkin Communications, Inc., Boulder City, NV
                [24] 24Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
                [25] 25Endocrine and Metabolic Consultants, Rockville, MD
                [26] 26Division of Endocrinology, Department of Pediatrics, University of Florida, Gainesville, FL
                [27] 27Division of Endocrinology, Diabetes and Metabolism, Miller School of Medicine, University of Miami, Miami, FL
                [28] 28Department of Pediatrics, Yale School of Medicine, New Haven, CT
                [29] 29Department of Diabetes, Metabolism and Endocrinology, Chiba University Graduate School of Medicine, Chiba, Japan
                Author notes
                Corresponding author: Christopher G. Parkin, chris@ 123456cgparkin.org
                Author information
                http://orcid.org/0000-0003-0773-6961
                http://orcid.org/0000-0002-9723-3876
                http://orcid.org/0000-0002-6099-2406
                http://orcid.org/0000-0002-5999-0091
                http://orcid.org/0000-0002-0273-4732
                http://orcid.org/0000-0002-9998-055X
                http://orcid.org/0000-0002-1580-8040
                http://orcid.org/0000-0002-7055-2084
                http://orcid.org/0000-0002-1384-1584
                http://orcid.org/0000-0002-5153-8324
                http://orcid.org/0000-0002-2425-9565
                http://orcid.org/0000-0002-4821-0117
                http://orcid.org/0000-0002-3646-1744
                http://orcid.org/0000-0001-6838-5355
                http://orcid.org/0000-0002-6187-8445
                http://orcid.org/0000-0003-3033-4813
                http://orcid.org/0000-0002-6616-5612
                Article
                2316
                10.2337/dc18-2316
                6973545
                30728224
                6cac9a60-3b68-416f-a23d-15bf08c3668c
                © 2019 by the American Diabetes Association.

                Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

                History
                Page count
                Pages: 8
                Categories
                0305
                Consensus Report

                Endocrinology & Diabetes
                Endocrinology & Diabetes

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