{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T13:31:37Z","timestamp":1777555897113,"version":"3.51.4"},"reference-count":47,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2020,2,21]],"date-time":"2020-02-21T00:00:00Z","timestamp":1582243200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Technology &amp; Therapeutics"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>We evaluated the real-life efficacy and safety of empagliflozin in combination with optimized insulin therapy in patients with type 1 diabetes (T1D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      This was a prospective study, including 27 patients with T1D treated with insulin therapy to whom empagliflozin was added according to an off-label protocol approved for use in clinical practice. The primary end point was the change in HbA\n                      <jats:sub>1c<\/jats:sub>\n                      52 weeks after the addition of empagliflozin to insulin therapy. Blood pressure (BP), weight, and safety were also assessed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      At week 52, the addition of empagliflozin significantly reduced HbA\n                      <jats:sub>1c<\/jats:sub>\n                      from 8.0%\u2009\u00b1\u20090.7% to 7.2%\u2009\u00b1\u20090.8% (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.001). The mean percentage of time in range for capillary glucose monitoring increased from 50% to 62% (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009=\u20090.008) in parallel to a \u22120.08 IU\/(kg\u00b7day) reduction in insulin requirements (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009=\u20090.031). There was also a reduction in the body weight (\u22128\u2009kg) and in systolic BP from 134 to 127\u2009mmHg (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.001). The most commonly reported adverse events were genitourinary infections (10 episodes in 52 weeks of follow-up). One patient developed an episode of mild diabetic ketoacidosis that motivated empagliflozin withdrawal. No severe hypoglycemic events were registered.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Our results suggested that the use of empagliflozin following a strict off-label protocol may represent an effective and safe option in real life among patients with T1D, improving metabolic control, and ameliorating some cardiovascular risk factors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/dia.2019.0316","type":"journal-article","created":{"date-parts":[[2019,10,23]],"date-time":"2019-10-23T14:26:05Z","timestamp":1571840765000},"page":"208-215","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and Safety of SGLT2 Inhibitors in Type 1 Diabetes After the Introduction of an Off-Label Use Protocol for Clinical Practice"],"prefix":"10.1177","volume":"22","author":[{"given":"Ane","family":"Bayona Cebada","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Nutrition, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L\u00eda","family":"Nattero-Ch\u00e1vez","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain."},{"name":"Diabetes, Obesity and Human Reproduction Research Group, Instituto Ram\u00f3n y Cajal de Investigaci\u00f3n Sanitaria (IRYCIS), CIBER Diabetes y Enfermedades Metab\u00f3licas Asociadas (CIBERDEM), Madrid, Spain."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Alonso D\u00edaz","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H\u00e9ctor F.","family":"Escobar-Morreale","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain."},{"name":"Diabetes, Obesity and Human Reproduction Research Group, Instituto Ram\u00f3n y Cajal de Investigaci\u00f3n Sanitaria (IRYCIS), CIBER Diabetes y Enfermedades Metab\u00f3licas Asociadas (CIBERDEM), Madrid, Spain."},{"name":"Department of Medicine, University of Alcal\u00e1, Madrid, Spain."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manuel","family":"Luque-Ram\u00edrez","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain."},{"name":"Diabetes, Obesity and Human Reproduction Research Group, Instituto Ram\u00f3n y Cajal de Investigaci\u00f3n Sanitaria (IRYCIS), CIBER Diabetes y Enfermedades Metab\u00f3licas Asociadas (CIBERDEM), Madrid, Spain."},{"name":"Department of Medicine, University of Alcal\u00e1, Madrid, Spain."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2020,2,21]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-2723"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(16)00039-5"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(17)30194-8"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.16008"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-0691"},{"issue":"1","key":"e_1_3_3_7_2","first-page":"S1","article-title":"American Diabetes Association","volume":"42","author":"Standards of Medical Care in Diabetes-2019","year":"2019","unstructured":"Standards of Medical Care in Diabetes-2019. 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