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Original Investigation
July 2017

Glucose Self-monitoring in Non–Insulin-Treated Patients With Type 2 Diabetes in Primary Care SettingsA Randomized Trial

Author Affiliations
  • 1Division of Endocrinology, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill
  • 2Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill
  • 3Departments of Medicine and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill
  • 4Center for Health Promotion and Disease Prevention, UNC Chapel Hill, North Carolina
  • 5School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill
  • 6Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill
JAMA Intern Med. 2017;177(7):920-929. doi:10.1001/jamainternmed.2017.1233
Key Points

Question  Is self-monitoring blood glucose levels effective for people with non–insulin-treated type 2 diabetes in terms of improving either hemoglobin A1c levels or health-related quality of life (HRQOL) in primary care practice?

Findings  In this pragmatic randomized clinical trial that included 450 patients randomized to 1 of 3 groups: no self-monitoring of blood glucose (SMBG), once-daily SMBG, and once-daily SMBG with enhanced patient feedback. There were no significant differences in glycemic control across all groups, nor were there significant differences found in HRQOL.

Meaning  Routine self-monitoring of blood glucose levels does not significantly improve hemoglobin A1c levels or HRQOL for most patients with non–insulin-treated type 2 diabetes; patients and clinicians should consider the specifics of each clinical situation as they decide whether to test or not to test.

Abstract

Importance  The value of self-monitoring of blood glucose (SMBG) levels in patients with non–insulin-treated type 2 diabetes has been debated.

Objective  To compare 3 approaches of SMBG for effects on hemoglobin A1c levels and health-related quality of life (HRQOL) among people with non–insulin-treated type 2 diabetes in primary care practice.

Design, Setting, and Participants  The Monitor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non–insulin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A1c) levels higher than 6.5% but lower than 9.5% within the 6 months preceding screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. Of the 1032 assessed for eligibility, 450 were randomized.

Interventions  No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the meter.

Main Outcomes and Measures  Coprimary outcomes included hemoglobin A1c levels and HRQOL at 52 weeks.

Results  A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A1c levels across all 3 groups (P = .74; estimated adjusted mean hemoglobin A1c difference, SMBG with messaging vs no SMBG, −0.09%; 95% CI, −0.31% to 0.14%; SMBG vs no SMBG, −0.05%; 95% CI, −0.27% to 0.17%). There were also no significant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation.

Conclusions and Relevance  In patients with non–insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addition of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control.

Trial Registration  clinicaltrials.gov Identifier: NCT02033499

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