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Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study
BACKGROUND: V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. Th...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7060972/ https://www.ncbi.nlm.nih.gov/pubmed/31833010 http://dx.doi.org/10.1007/s40801-019-00173-8 |
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author | Grunberger, George Rosenfeld, Cheryl R. Bode, Bruce W. Abbott, Scott D. Nikkel, Carla Shi, Leon Strange, Poul |
author_facet | Grunberger, George Rosenfeld, Cheryl R. Bode, Bruce W. Abbott, Scott D. Nikkel, Carla Shi, Leon Strange, Poul |
author_sort | Grunberger, George |
collection | PubMed |
description | BACKGROUND: V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use. METHODS: This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go. RESULTS: One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (P = 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (P < 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year. CONCLUSION: In a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions. ClinicalTrial.gov registry identifier: NCT01326598. |
format | Online Article Text |
id | pubmed-7060972 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-70609722020-03-23 Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study Grunberger, George Rosenfeld, Cheryl R. Bode, Bruce W. Abbott, Scott D. Nikkel, Carla Shi, Leon Strange, Poul Drugs Real World Outcomes Original Research Article BACKGROUND: V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use. METHODS: This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go. RESULTS: One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (P = 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (P < 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year. CONCLUSION: In a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions. ClinicalTrial.gov registry identifier: NCT01326598. Springer International Publishing 2019-12-12 /pmc/articles/PMC7060972/ /pubmed/31833010 http://dx.doi.org/10.1007/s40801-019-00173-8 Text en © The Author(s) 2019 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/ |
spellingShingle | Original Research Article Grunberger, George Rosenfeld, Cheryl R. Bode, Bruce W. Abbott, Scott D. Nikkel, Carla Shi, Leon Strange, Poul Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
title | Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
title_full | Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
title_fullStr | Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
title_full_unstemmed | Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
title_short | Effectiveness of V-Go(®) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
title_sort | effectiveness of v-go(®) for patients with type 2 diabetes in a real-world setting: a prospective observational study |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7060972/ https://www.ncbi.nlm.nih.gov/pubmed/31833010 http://dx.doi.org/10.1007/s40801-019-00173-8 |
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