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Brazilian multicenter study for the evaluation of patients’ satisfaction of blood glucose self-monitoring with BGStar® blood glucose meter in insulinized patients with diabetes mellitus type 1 and 2

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Hissa, Miguel Nasser·2016·Diabetology & Metabolic Syndrome

Abstract

BACKGROUND: Diabetes mellitus (DM) is considered a global epidemic, and patient self-management education and support are critical in preventing and reducing the risk of complications. Self-monitoring of blood glucose (SMBG) is essential for care of individuals with DM, helping patients to achieve and maintain target blood glucose levels. The purpose of this study is to compare the satisfaction of insulinized DM patients on SMBG with use of investigational blood glucose meter (BGM) versus their routine device. METHODS: A national, multicenter, open-label, phase 4 study was conducted on patients with type 1 or 2 DM under insulin therapy regimen, who were asked to use investigational BGM instead of their usual BGM device. The study was performed in 12 centers in Brazil for 12 weeks, with an extension period of 12 weeks. The primary endpoint was to measure the variation on the patients' level of satisfaction with investigational versus routine BGM, between visits, using a Visual Analogue Scale (VAS). Secondary endpoints addressed handling aspects, satisfaction, adherence and level of functionality and safety of investigational BGM. RESULTS: The study included 292 patients (36.6 % DM1 and 63.4 % DM2), mean age 50.9 years old (±17.3 years), 57.5 % females. There was statistically significant improvement in global satisfaction with investigational BGM compared with routine BGM according to VAS [mean VAS score raised from 78.8 mm (SD = 18.0) to 90.8 mm (SD = 12.2) between visits]. After 12 weeks, level of satisfaction with investigational BGM according to questionnaires was superior to routine BGM regardless of age group (p < 0.001), type of DM (p < 0.001) or insulin regimen (p < 0.001). Investigational BGM was also regarded as safe, with 10 patients (3.4 %) reporting a total of 13 adverse events during the study. CONCLUSIONS: Levels of satisfaction during SMBG were higher with use of investigational BGM and the device was deemed safe and easy to handle.

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  • In a Brazilian national multicenter study, acceptance of SMBG varied depending on the device used (time for results, amount of blood needed, technology) and people's characteristics (age, glycemic control).

    “a national multicenter study showed that acceptance of SMBG varied depending both on the device used (considering time for getting results, amount of blood needed, technology used) and peoples’ characteristics (age, glycemic control) [64].”

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Authors
Hissa, M. N.
Affiliations
Unichristus (BR)
Corresponding author
Hissa, Miguel Nasser
Venue
Diabetology & Metabolic Syndrome
Published
2016-09-13
Volume
8
Issue
1
Pages
66-66
ISSN
1758-5996 (ISSN-L)
OpenAlex
W2519070048
Cited by
1
References
19
Citations by year
2022: 1
FWCI
0.00
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Diabetology & Metabolic Syndrome (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
Sanofi-Aventis
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
self-monitoring of blood glucose, blood glucose meters, patient satisfaction, insulin therapy, type 1 diabetes, type 2 diabetes, device safety, adherence, self-management education

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