Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial
Objectives: To determine whether self-monitoring of blood glucose (SMBG), either alone or with additional instruction in incorporating the results into self-care, is more effective than usual care in improving glycaemic control in non-insulin-treated diabetes. Design: An open, parallel group randomi...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
2009
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| _version_ | 1826270138679164928 |
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| author | Farmer, A Wade, A French, D Simon, J Yudkin, P Gray, A Craven, A Goyder, L Holman, R Mant, D Kinmonth, A Neil, H |
| author_facet | Farmer, A Wade, A French, D Simon, J Yudkin, P Gray, A Craven, A Goyder, L Holman, R Mant, D Kinmonth, A Neil, H |
| author_sort | Farmer, A |
| collection | OXFORD |
| description | Objectives: To determine whether self-monitoring of blood glucose (SMBG), either alone or with additional instruction in incorporating the results into self-care, is more effective than usual care in improving glycaemic control in non-insulin-treated diabetes. Design: An open, parallel group randomised controlled trial. Setting: 24 general practices in Oxfordshire and 24 in South Yorkshire, UK. Participants: Patients with non-insulin-treated type 2 diabetes, aged ≥25 years and with glycosylated haemoglobin (HbAlc) ≥6.2%. Interventions: A total of 453 patients were individually randomised to one of: (1) standardised usual care with 3-monthly HbAlc (control, n = 152); (2) blood glucose self-testing with patient training focused on clinician interpretation of results in addition to usual care (less intensive self-monitoring, n = 150); (3) SMBG with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (more intensive self-monitoring, n = 151). Main outcome measures: The primary outcome was HBAlc at 12 months, and an intention-to-treat analysis, including all patients, was undertaken. Blood pressure, lipids, episodes of hypoglycaemia and quality of life, measured with the EuroQol 5 dimensions (EQ-5D), were secondary measures. An economic analysis was also carried out, and questionnaires were used to measure well-being, beliefs about use of SMBG and self-reports of medication taking, dietary and physical activities, and health-care resource use. Results: The differences in 12-month HbAlc between the three groups (adjusted for baseline HbAlc) were not statistically significant (p = 0.12). The difference in unadjusted mean change in HbAlc from baseline to 12 months between the control and less intensive self-monitoring groups was -0.14% [95% confidence interval (Cl) -0.35 to 0.07] and between the control and more intensive self-monitoring groups was -0.17% (95% Cl -0.37 to 0.03). There was no evidence of a significantly different impact of self-monitoring on glycaemic control when comparing subgroups of patients defined by duration of diabetes, therapy, diabetes-related complications and EQ-5D score. The economic analysis suggested that SMBG resulted in extra health-care costs and was unlikely to be cost-effective if used routinely. There appeared to be an initial negative impact of SMBG on quality of life measured on the EQ-5D, and the potential additional lifetime gains in quality-adjusted life-years, resulting from the lower levels of risk factors achieved at the end of trial follow-up, were outweighed by these initial impacts for both SMBG groups compared with control. Some patients felt that SMBG was helpful, and there was evidence that those using more intensive self-monitoring perceived diabetes as having more serious consequences. Patients using SMBG were often not clear about the relationship between their behaviour and the test results. Conclusions: While the data do not exclude the possibility of a clinically important benefit for specific subgroups of patients in initiating good glycaemic control, SBMG by non-insulin-treated patients, with or without instruction in incorporating finding into self-care, did not lead to a significant improvement in glycaemic control compared with usual care monitored by HbAlc levels. There was no convincing evidence to support a recommendation for routine self-monitoring of all patients and no evidence of improved glycaemic control in predefined subgroups of patients. |
| first_indexed | 2024-03-06T21:36:08Z |
| format | Journal article |
| id | oxford-uuid:46554ad7-2462-4477-9768-fa86c9188306 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T21:36:08Z |
| publishDate | 2009 |
| record_format | dspace |
| spelling | oxford-uuid:46554ad7-2462-4477-9768-fa86c91883062022-03-26T15:13:05ZBlood glucose self-monitoring in type 2 diabetes: A randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:46554ad7-2462-4477-9768-fa86c9188306EnglishSymplectic Elements at Oxford2009Farmer, AWade, AFrench, DSimon, JYudkin, PGray, ACraven, AGoyder, LHolman, RMant, DKinmonth, ANeil, HObjectives: To determine whether self-monitoring of blood glucose (SMBG), either alone or with additional instruction in incorporating the results into self-care, is more effective than usual care in improving glycaemic control in non-insulin-treated diabetes. Design: An open, parallel group randomised controlled trial. Setting: 24 general practices in Oxfordshire and 24 in South Yorkshire, UK. Participants: Patients with non-insulin-treated type 2 diabetes, aged ≥25 years and with glycosylated haemoglobin (HbAlc) ≥6.2%. Interventions: A total of 453 patients were individually randomised to one of: (1) standardised usual care with 3-monthly HbAlc (control, n = 152); (2) blood glucose self-testing with patient training focused on clinician interpretation of results in addition to usual care (less intensive self-monitoring, n = 150); (3) SMBG with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (more intensive self-monitoring, n = 151). Main outcome measures: The primary outcome was HBAlc at 12 months, and an intention-to-treat analysis, including all patients, was undertaken. Blood pressure, lipids, episodes of hypoglycaemia and quality of life, measured with the EuroQol 5 dimensions (EQ-5D), were secondary measures. An economic analysis was also carried out, and questionnaires were used to measure well-being, beliefs about use of SMBG and self-reports of medication taking, dietary and physical activities, and health-care resource use. Results: The differences in 12-month HbAlc between the three groups (adjusted for baseline HbAlc) were not statistically significant (p = 0.12). The difference in unadjusted mean change in HbAlc from baseline to 12 months between the control and less intensive self-monitoring groups was -0.14% [95% confidence interval (Cl) -0.35 to 0.07] and between the control and more intensive self-monitoring groups was -0.17% (95% Cl -0.37 to 0.03). There was no evidence of a significantly different impact of self-monitoring on glycaemic control when comparing subgroups of patients defined by duration of diabetes, therapy, diabetes-related complications and EQ-5D score. The economic analysis suggested that SMBG resulted in extra health-care costs and was unlikely to be cost-effective if used routinely. There appeared to be an initial negative impact of SMBG on quality of life measured on the EQ-5D, and the potential additional lifetime gains in quality-adjusted life-years, resulting from the lower levels of risk factors achieved at the end of trial follow-up, were outweighed by these initial impacts for both SMBG groups compared with control. Some patients felt that SMBG was helpful, and there was evidence that those using more intensive self-monitoring perceived diabetes as having more serious consequences. Patients using SMBG were often not clear about the relationship between their behaviour and the test results. Conclusions: While the data do not exclude the possibility of a clinically important benefit for specific subgroups of patients in initiating good glycaemic control, SBMG by non-insulin-treated patients, with or without instruction in incorporating finding into self-care, did not lead to a significant improvement in glycaemic control compared with usual care monitored by HbAlc levels. There was no convincing evidence to support a recommendation for routine self-monitoring of all patients and no evidence of improved glycaemic control in predefined subgroups of patients. |
| spellingShingle | Farmer, A Wade, A French, D Simon, J Yudkin, P Gray, A Craven, A Goyder, L Holman, R Mant, D Kinmonth, A Neil, H Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial |
| title | Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial |
| title_full | Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial |
| title_fullStr | Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial |
| title_full_unstemmed | Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial |
| title_short | Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial |
| title_sort | blood glucose self monitoring in type 2 diabetes a randomised controlled trial |
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