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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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2019
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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. |
format | Online Article Text |
id | pubmed-6965554 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
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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