Cargando…

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‐...

Descripción completa

Detalles Bibliográficos
Autores principales: Ogawa, Wataru, Hirota, Yushi, Osonoi, Takeshi, Tosaki, Takahiro, Kato, Yoshiro, Utsunomiya, Kazunori, Nishimura, Rimei, Nakamura, Jiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
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
_version_ 1783631298446753792
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
work_keys_str_mv AT ogawawataru effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT hirotayushi effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT osonoitakeshi effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT tosakitakahiro effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT katoyoshiro effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT utsunomiyakazunori effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT nishimurarimei effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan
AT nakamurajiro effectofthefreestylelibreflashglucosemonitoringsystemonglycemiccontrolinindividualswithtype2diabetestreatedwithbasalbolusinsulintherapyanopenlabelprospectivemulticentertrialinjapan