Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol
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Young, Laura A, et al. Three Approaches to Glucose Monitoring In Non-insulin Treated Diabetes: a Pragmatic Randomized Clinical Trial Protocol. BioMed Central, 2017. https://doi.org/10.17615/8vw2-vf54APA
Young, L., Buse, J., Weaver, M., Vu, M., Reese, A., Mitchell, C., Blakeney, T., Grimm, K., Rees, J., & Donahue, K. (2017). Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol. BioMed Central. https://doi.org/10.17615/8vw2-vf54Chicago
Young, Laura A, John Buse, Mark Weaver, Maihan B Vu, April Reese, C Madeline Mitchell, Tamara Blakeney et al. 2017. Three Approaches to Glucose Monitoring In Non-Insulin Treated Diabetes: a Pragmatic Randomized Clinical Trial Protocol. BioMed Central. https://doi.org/10.17615/8vw2-vf54- Creator
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Young, Laura A
- Affiliation: Cecil G. Sheps Center for Health Services Research
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Buse, John
- Affiliation: Cecil G. Sheps Center for Health Services Research
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Weaver, Mark
- Affiliation: Gillings School of Global Public Health
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Vu, Maihan B
- Affiliation: UNC Center for Health Promotion and Disease Prevention
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Reese, April
- Other Affiliation: North Carolina Division of Public Health, Chapel Hill, USA
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Mitchell, C Madeline
- Affiliation: Cecil G. Sheps Center for Health Services Research
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Blakeney, Tamara
- Affiliation: Cecil G. Sheps Center for Health Services Research
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Grimm, Kimberlea
- Affiliation: Cecil G. Sheps Center for Health Services Research
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Rees, Jennifer
- Affiliation: Cecil G. Sheps Center for Health Services Research
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Donahue, Katrina
- Affiliation: School of Medicine, Department of Family Medicine, Cecil G. Sheps Center for Health Services Research
- Abstract
- Abstract Background For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting. Methods/Design Using stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control. Discussion This pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed. Trial registration ClinicalTrials.gov NCT02033499 , January 9, 2014.
- Date of publication
- May 25, 2017
- DOI
- Identifier
- Resource type
- Article
- Rights statement
- In Copyright
- Rights holder
- The Author(s).
- Language
- English
- Bibliographic citation
- BMC Health Services Research. 2017 May 25;17(1):369
- Publisher
- BioMed Central
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