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Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan
AIMS/INTRODUCTION: We investigated the effect of FreeStyle Libre(TM) on glycemic control in Japanese type 2 diabetes patients treated with basal–bolus insulin therapy. MATERIALS AND METHODS: This prospective, 90‐day single‐arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14‐...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779269/ https://www.ncbi.nlm.nih.gov/pubmed/32562376 http://dx.doi.org/10.1111/jdi.13327 |
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author | Ogawa, Wataru Hirota, Yushi Osonoi, Takeshi Tosaki, Takahiro Kato, Yoshiro Utsunomiya, Kazunori Nishimura, Rimei Nakamura, Jiro |
author_facet | Ogawa, Wataru Hirota, Yushi Osonoi, Takeshi Tosaki, Takahiro Kato, Yoshiro Utsunomiya, Kazunori Nishimura, Rimei Nakamura, Jiro |
author_sort | Ogawa, Wataru |
collection | PubMed |
description | AIMS/INTRODUCTION: We investigated the effect of FreeStyle Libre(TM) on glycemic control in Japanese type 2 diabetes patients treated with basal–bolus insulin therapy. MATERIALS AND METHODS: This prospective, 90‐day single‐arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14‐day masked baseline phase was followed by an 11‐week treatment phase during which participants used the device to monitor glucose levels. The primary end‐point was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76–90). Secondary end‐points included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire. RESULTS: Time spent in hypoglycemia was low at baseline (0.51 ± 0.93 h/day) and did not significantly decrease at study end (0.47 ± 0.63 h/day, P = 0.6354). Time in range, time in hyperglycemia and estimated A1c all improved versus baseline (by +1.7 ± 3.0 h/day, −1.6 ± .4 h/day and −0.4 ± 0.8%, respectively, P < 0.0001 in each). Finger stick tests fell from 2.9 ± 1.3 to 1.9 ± 1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. The mean treatment satisfaction score increased by 11.8 ± 5.3 (P < 0.0001). Two severe hypoglycemia‐related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device‐related skin trauma, site discomfort or subcutaneous bleeding. CONCLUSIONS: Use of FreeStyle Libre by Japanese type 2 patients diabetes treated with basal–bolus insulin therapy showed a low baseline of hypoglycemia, and enabled improved glycemic control and treatment satisfaction. |
format | Online Article Text |
id | pubmed-7779269 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-77792692021-01-08 Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan Ogawa, Wataru Hirota, Yushi Osonoi, Takeshi Tosaki, Takahiro Kato, Yoshiro Utsunomiya, Kazunori Nishimura, Rimei Nakamura, Jiro J Diabetes Investig Articles AIMS/INTRODUCTION: We investigated the effect of FreeStyle Libre(TM) on glycemic control in Japanese type 2 diabetes patients treated with basal–bolus insulin therapy. MATERIALS AND METHODS: This prospective, 90‐day single‐arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14‐day masked baseline phase was followed by an 11‐week treatment phase during which participants used the device to monitor glucose levels. The primary end‐point was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76–90). Secondary end‐points included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire. RESULTS: Time spent in hypoglycemia was low at baseline (0.51 ± 0.93 h/day) and did not significantly decrease at study end (0.47 ± 0.63 h/day, P = 0.6354). Time in range, time in hyperglycemia and estimated A1c all improved versus baseline (by +1.7 ± 3.0 h/day, −1.6 ± .4 h/day and −0.4 ± 0.8%, respectively, P < 0.0001 in each). Finger stick tests fell from 2.9 ± 1.3 to 1.9 ± 1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. The mean treatment satisfaction score increased by 11.8 ± 5.3 (P < 0.0001). Two severe hypoglycemia‐related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device‐related skin trauma, site discomfort or subcutaneous bleeding. CONCLUSIONS: Use of FreeStyle Libre by Japanese type 2 patients diabetes treated with basal–bolus insulin therapy showed a low baseline of hypoglycemia, and enabled improved glycemic control and treatment satisfaction. John Wiley and Sons Inc. 2020-09-09 2021-01 /pmc/articles/PMC7779269/ /pubmed/32562376 http://dx.doi.org/10.1111/jdi.13327 Text en © 2020 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Articles Ogawa, Wataru Hirota, Yushi Osonoi, Takeshi Tosaki, Takahiro Kato, Yoshiro Utsunomiya, Kazunori Nishimura, Rimei Nakamura, Jiro Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan |
title | Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan |
title_full | Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan |
title_fullStr | Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan |
title_full_unstemmed | Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan |
title_short | Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: An open label, prospective, multicenter trial in Japan |
title_sort | effect of the freestyle libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal–bolus insulin therapy: an open label, prospective, multicenter trial in japan |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779269/ https://www.ncbi.nlm.nih.gov/pubmed/32562376 http://dx.doi.org/10.1111/jdi.13327 |
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