Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol Public Deposited

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Creator
  • Grimm, Kimberlea
    • Affiliation: Cecil G. Sheps Center for Health Services Research
  • Rees, Jennifer
    • Affiliation: Cecil G. Sheps Center for Health Services Research
  • Vu, Maihan B
    • Affiliation: UNC Center for Health Promotion and Disease Prevention
  • Blakeney, Tamara
    • Affiliation: Cecil G. Sheps Center for Health Services Research
  • Reese, April
    • Other Affiliation: North Carolina Division of Public Health, Chapel Hill, USA
  • Weaver, Mark
    • Affiliation: Gillings School of Global Public Health
  • Mitchell, C Madeline
    • Affiliation: Cecil G. Sheps Center for Health Services Research
  • Donahue, Katrina
    • Affiliation: School of Medicine, Department of Family Medicine, Cecil G. Sheps Center for Health Services Research
  • Young, Laura A
    • Affiliation: School of Medicine, Department of Medicine, Division of Endocrinology and Metabolism, Cecil G. Sheps Center for Health Services Research
  • Buse, John
    • Affiliation: School of Medicine, Department of Medicine, Division of Endocrinology and Metabolism, 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
Identifier
  • doi:10.1186/s12913-017-2202-7
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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