Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial
Open accessAbstract
OBJECTIVE: To determine whether self monitoring, alone or with instruction in incorporating the results into self care, is more effective than usual care in improving glycaemic control in non-insulin treated patients with type 2 diabetes. DESIGN: Three arm, open, parallel group randomised trial. SETTING: 48 general practices in Oxfordshire and South Yorkshire. PARTICIPANTS: 453 patients with non-insulin treated type 2 diabetes (mean age 65.7 years) for a median duration of three years and a mean haemoglobin A1c level of 7.5%. INTERVENTIONS: Standardised usual care with measurements of HbA1c every three months as the control group (n=152), blood glucose self monitoring with advice for patients to contact their doctor for interpretation of results, in addition to usual care (n=150), and blood glucose self monitoring with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (n=151). MAIN OUTCOME MEASURE: HbA1c level measured at 12 months. RESULTS: At 12 months the differences in HbA1c level between the three groups (adjusted for baseline HbA1c level) were not statistically significant (P=0.12). The difference in unadjusted mean change in HbA1c level from baseline to 12 months between the control and less intensive self monitoring groups was -0.14% (95% confidence interval -0.35% to 0.07%) and between the control and more intensive self monitoring groups was -0.17% (-0.37% to 0.03%). CONCLUSIONS: Evidence is not convincing of an effect of self monitoring blood glucose, with or without instruction in incorporating findings into self care, in improving glycaemic control compared with usual care in reasonably well controlled non-insulin treated patients with type 2 diabetes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47464659.
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Current evidence on SMBG in insulin-naïve type 2 diabetic patients is mixed, with some studies showing significant glycemic benefits and others showing no significant benefits.
“Current evidence in this latter population is mixed, with some studies pointing to significant glycemic benefits resulting from SMBG use (8–10), while others have shown no significant benefits (11–13).”
From Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes (2011) · cites this paper as [11]
In a retrospective analysis, frequency of blood glucose monitoring has been shown to predict A1C levels.
“Frequency of BGM (in a retrospective analysis) has been shown to be predictive of A1C levels.142–146”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [146]
The Outcome measures section says the trial recorded testing frequency, and Statistical analysis describes comparisons of HbA1c between randomized groups. Neither passage reports a retrospective analysis showing that monitoring frequency predicts HbA1c; searches for that association found no such passage in our copy. (LLM, conf=0.73)
Experimental — accuracy not yet measuredForty-four RCTs examined the impact of interventions on disease-specific outcomes.
“Forty four RCTs examined the impact of interventions on disease specific outcomes”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [48]
The Interventions and Secondary outcomes sections describe one randomized trial of blood-glucose self-monitoring, not an assessment of 44 RCTs. Searches for “forty four RCTs” and “44 randomised controlled trials” found no passage in our copy giving that count or describing their disease-specific outcomes; page numbers were unavailable. (LLM, conf=0.77)
Experimental — accuracy not yet measuredThe DiGEM trial found evidence not convincing of an effect of SMBG on glycemic control compared with usual care in reasonably well controlled non-insulin-treated type 2 diabetes patients.
“Evidence is not convincing of an effect of self monitoring blood glucose . . . in improving glycaemic control [as assessed by HbA 1c ] compared with usual care in reasonably well controlled non-insulin treated patients with type 2 diabetes.”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [107]
Oral glucose-lowering regimens that do not include sulfonylureas or glinides are not likely to cause hypoglycemia.
“Oral glucose-lowering regimens that do not include sulfonylureas or glinides, and are therefore not likely to cause hypoglycemia, usually do not require SMBG (86).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [86]
Several recent trials have called into question the clinical utility and cost-effectiveness of routine SMBG in non-insulin-treated patients.
“Several recent trials have called into question the clinical utility and cost-effectiveness of routine SMBG in non–insulin-treated patients (34–36).”
From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [34]
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Comparison of different models of structured self-monitoring of blood glucose in type 2 diabetes
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- Authors
- Farmer, A., Wade, A., Goyder, E., Yudkin, P., French, D., Craven, A., Holman, R., Kinmonth, A.-L., & Neil, A.
- Affiliations
- University of Oxford (GB)
- Johns Hopkins University (US)
- University of Sheffield (GB)
- Coventry University (GB)
- University of Cambridge (GB)
- Corresponding author
- Farmer, Andrew
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2007-06-25
- Volume
- 335
- Issue
- 7611
- Pages
- 132
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC1925177
- OpenAlex
- W2123342488
- Cited by
- 407
- References
- 35
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 5 · 2023: 8 · 2022: 12 · 2021: 10 · 2020: 12 · 2019: 13 · 2018: 14 · 2017: 17 · 2016: 18 · 2015: 20 · 2014: 26 · 2013: 23 · 2012: 27
- FWCI
- 38.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- BMJ (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Coventry University Open Collections (Coventry university) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Pure (Coventry University) (submittedVersion, other-oa)
- Research Explorer (The University of Manchester) (submittedVersion)
- The Open Collections (Coventry University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- 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, patient education, self-care, usual care, general practice
- MeSH terms
- Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Male, Middle Aged, Blood Glucose Self-Monitoring, Treatment Outcome
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