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Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety

INTRODUCTION: Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patien...

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Autores principales: Ponzani, Paola, Berra, Cesare, Di Lelio, Alessandra, Del Sindaco, Paola, Di Loreto, Chiara, Reggiani, Francesco, Lucisano, Giuseppe, Rossi, Maria Chiara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6965554/
https://www.ncbi.nlm.nih.gov/pubmed/31707573
http://dx.doi.org/10.1007/s13300-019-00722-y
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author Ponzani, Paola
Berra, Cesare
Di Lelio, Alessandra
Del Sindaco, Paola
Di Loreto, Chiara
Reggiani, Francesco
Lucisano, Giuseppe
Rossi, Maria Chiara
author_facet Ponzani, Paola
Berra, Cesare
Di Lelio, Alessandra
Del Sindaco, Paola
Di Loreto, Chiara
Reggiani, Francesco
Lucisano, Giuseppe
Rossi, Maria Chiara
author_sort Ponzani, Paola
collection PubMed
description INTRODUCTION: Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patients with type 1 diabetes under routine clinical practice conditions. METHODS: This was an observational longitudinal multicenter study. A retrospective chart review of all patients with type 1 diabetes who were switched from basal insulin to IDeg was performed, and temporal trends in clinical outcomes were assessed. RESULTS: Data obtained from 195 patients, with a median age of 42.8 [interquartile range (IQR) 24.6–56.4] years and a median diabetes duration of 16 (IQR 10.0–28) years, were analyzed. Median follow-up was 9.5 (IQR 7.7–11.3) months. Improvements were found in glycated hemoglobin (− 0.34%; p  < 0.0001), fasting blood glucose (− 24.82 mg/dL; p  < 0.0001), post-prandial glucose (− 17.23 mg/dL; p  = 0.0009), glycemic variability as indicated by standard deviation of blood glucose (− 5.67 mg/dL; p  < 0.0001) and high blood glucose index (− 3.77; p < 0.0001). Body weight and body mass index remained substantially stable during the follow-up (− 0.18 kg; p = 0.56 and − 0.12; p = 0.42, respectively). Risk of nocturnal hypoglycemia decreased by 52% [incidence rate ratio 0.48; 95% confidence interval (CI) 0.29–0.77] and risk of total hypoglycemic episodes by 41% (incidence ratio 0.59; 95% CI 0.45–0.83). Basal and short-acting insulin doses decreased by − 1.4 and − 3.1 IU, respectively. CONCLUSION: Switching patients with type 1 diabetes to IDeg from other basal insulins was associated with relevant improvements in metabolic control and glycemic variability without weight gain; the risk of hypoglycemic episodes also significantly declined. FUNDING: Novo Nordisk S.p.A. unconditional grant. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-019-00722-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-69655542020-01-30 Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety Ponzani, Paola Berra, Cesare Di Lelio, Alessandra Del Sindaco, Paola Di Loreto, Chiara Reggiani, Francesco Lucisano, Giuseppe Rossi, Maria Chiara Diabetes Ther Original Research INTRODUCTION: Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patients with type 1 diabetes under routine clinical practice conditions. METHODS: This was an observational longitudinal multicenter study. A retrospective chart review of all patients with type 1 diabetes who were switched from basal insulin to IDeg was performed, and temporal trends in clinical outcomes were assessed. RESULTS: Data obtained from 195 patients, with a median age of 42.8 [interquartile range (IQR) 24.6–56.4] years and a median diabetes duration of 16 (IQR 10.0–28) years, were analyzed. Median follow-up was 9.5 (IQR 7.7–11.3) months. Improvements were found in glycated hemoglobin (− 0.34%; p  < 0.0001), fasting blood glucose (− 24.82 mg/dL; p  < 0.0001), post-prandial glucose (− 17.23 mg/dL; p  = 0.0009), glycemic variability as indicated by standard deviation of blood glucose (− 5.67 mg/dL; p  < 0.0001) and high blood glucose index (− 3.77; p < 0.0001). Body weight and body mass index remained substantially stable during the follow-up (− 0.18 kg; p = 0.56 and − 0.12; p = 0.42, respectively). Risk of nocturnal hypoglycemia decreased by 52% [incidence rate ratio 0.48; 95% confidence interval (CI) 0.29–0.77] and risk of total hypoglycemic episodes by 41% (incidence ratio 0.59; 95% CI 0.45–0.83). Basal and short-acting insulin doses decreased by − 1.4 and − 3.1 IU, respectively. CONCLUSION: Switching patients with type 1 diabetes to IDeg from other basal insulins was associated with relevant improvements in metabolic control and glycemic variability without weight gain; the risk of hypoglycemic episodes also significantly declined. FUNDING: Novo Nordisk S.p.A. unconditional grant. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-019-00722-y) contains supplementary material, which is available to authorized users. Springer Healthcare 2019-11-09 2020-01 /pmc/articles/PMC6965554/ /pubmed/31707573 http://dx.doi.org/10.1007/s13300-019-00722-y Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Ponzani, Paola
Berra, Cesare
Di Lelio, Alessandra
Del Sindaco, Paola
Di Loreto, Chiara
Reggiani, Francesco
Lucisano, Giuseppe
Rossi, Maria Chiara
Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety
title Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety
title_full Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety
title_fullStr Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety
title_full_unstemmed Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety
title_short Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety
title_sort switching patients with type 1 diabetes to insulin degludec from other basal insulins: real-world data of effectiveness and safety
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6965554/
https://www.ncbi.nlm.nih.gov/pubmed/31707573
http://dx.doi.org/10.1007/s13300-019-00722-y
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