Glucose Self-monitoring in Non–Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial
Open accessAbstract
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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In people with type 2 diabetes not using insulin, routine glucose monitoring is of limited additional clinical benefit while adding burden and cost.
“In people with type 2 diabetes not using insulin, routine glucose monitoring is of limited additional clinical bene fi t while adding burden and cost (54,55).”
From Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022) · cites this paper as [55]
The Abstract reports no clinically or statistically significant improvement in glycemic control or health-related quality of life after one year of self-monitoring in non-insulin-treated patients. The Discussion raises possible user fatigue, but our copy does not establish that monitoring adds burden or cost; the cost-effectiveness study appears only in the References. (LLM, conf=0.82)
Experimental — accuracy not yet measuredA pragmatic, open-label randomized trial found no clinically or statistically significant differences at 1 year in glycemic control (as assessed by HbA 1c) or health-related quality of life between patients who performed BGM, with or without enhanced feedback, and those who did not.
“The study found no clinically or statistically significant differences at 1 year in glycemic control (as assessed by HbA 1c ) or health-related quality of life between patients who performed BGM, with or without enhanced feedback, and those who did not.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [115]
In people with type 2 diabetes not taking insulin, routine glucose monitoring may have limited additional clinical benefit; by itself, even with education, it has shown limited improvement in outcomes.
“In people with type 2 diabetes not taking insulin, routine glucose monitoring may be of limited additional clinical benefit.By itself, even when combined with education, this practice has shown limited improvement in outcomes (31).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [31]
A trial of once-daily BGM with enhanced feedback through messaging found no clinically or statistically significant change in A1C at 1 year.
“A trial of once-daily BGM that included enhanced feedback from people with diabetes through messaging found no clinically or statistically significant change in A1C levels at 1 year (31).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [31]
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- Authors
- Young, L. A., Buse, J. B., Weaver, M. A., Vu, M. B., Mitchell, C. M., Blakeney, T., Grimm, K., Rees, J., Niblock, F., Donahue, K. E., & for the Monitor Trial Group
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2017-07-01
- Volume
- 177
- Issue
- 7
- Pages
- 920
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC5818811
- OpenAlex
- W2623217224
- Semantic Scholar
- 76d70b09da394642c3c7a290cd3a3f25f4edee60
- Cited by
- 148
- References
- 38
- Citations by year
- 2026: 7 · 2025: 9 · 2024: 9 · 2023: 14 · 2022: 15 · 2021: 29 · 2020: 18 · 2019: 19 · 2018: 17 · 2017: 11
- FWCI
- 14.04
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Internal Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association (UL1TR001111)
- Bristol-Myers Squibb
- Eli Lilly and Company
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Intarcia Therapeutics
- Halozyme
- AstraZeneca HealthCare Foundation
- MacroGenics
- Novo Nordisk
- Astellas Pharma
- National Institutes of Health (UL1TR002489)
- National Center for Advancing Translational Sciences
- 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, type 2 diabetes, non-insulin-treated diabetes, glycemic control, HbA1c, health-related quality of life, patient feedback, message tailoring, blood glucose meters, primary care, hypoglycemia, insulin initiation, diabetes self-management education
- MeSH terms
- Adult, Aged, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, North Carolina, Outcome and Process Assessment, Health Care, Primary Health Care, Quality of Life, Blood Glucose Self-Monitoring, Disease Management
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