Self-monitoring of blood glucose changed non-insulin-treated Type 2 diabetes patients' beliefs about diabetes and self-monitoring in a randomized trial. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. Self-monitoring of blood glucose in tablet-treated type 2 diabetic patients (ZODIAC). Self-monitoring of blood glucose in overweight type 2 diabetic patients. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Treating depression in diabetes patients: does a nurse-administered minimal psychological intervention affect diabetes-specific quality of life and glycaemic control? A randomized controlled trial. Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial. The efficacy of self-monitoring of blood glucose in the management of patients with type 2 diabetes treated with a gliclazide modified release-based regimen. A multicentre, randomized, parallel-group, 6-month evaluation (DINAMIC 1 study). Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Results of a randomised controlled cross-over trial on the effect of continuous subcutaneous glucose monitoring (CGMS) on glycaemic control in children and adolescents with type 1 diabetes. Experience-based group education in Type 2 diabetes: a randomised controlled trial. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system.
To determine whether differences in beliefs about diabetes and its treatment resulted from different intensities of self-monitoring of blood glucose (SMBG) in non-insulin treated patients with Type 2 diabetes in the Diabetes Glycaemic Education and Monitoring (DiGEM) trial.
                Patients (n = 453) were randomized to usual care, less-intensive SMBG and more intensive SMBG. Beliefs about diabetes were measured with a standard questionnaire (the revised Illness Perceptions Questionnaire; IPQ-R). Changes in beliefs were analysed using analysis of covariance (ancova) with adjustment for baseline values. Mediation analyses assessed whether differences in behavioural outcomes between groups could be attributed to differences in beliefs.
                Completed questionnaires were returned by 339 patients (74.8%). Respondents were mean (+/- sd) age 65.9 +/- 10 years and with diabetes duration of 4.8 +/- 4.7 years (median 36, range 1-384 months). Concerns about the consequences of diabetes increased in both self-monitoring groups, relative to control subjects [P = 0.004; Cohen's d standardized effect size = 0.19 less intensive and d = 0.36 more intensive monitoring]. No other beliefs about diabetes differed between groups. Beliefs about the importance of self-testing increased in both self-monitoring groups relative to the usual-care group (P < 0.001; d = 0.57 less intensive and d = 0.63 more intensive monitoring). Changes in psychological well-being did not differ between groups, but control patients reported greater increases in general (P = 0.014) and specific (P < 0.001) dietary adherence than did patients in the self-monitoring groups. These outcomes were not mediated by intervention-related changes in beliefs.
                Despite changes in some beliefs about diabetes differing between groups there were no corresponding changes in self-reported health behaviours. This suggests that changes in illness beliefs resulting from SMBG do not cause changes in diabetes-related health behaviours. 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.
                Three arm, open, parallel group randomised trial.
                48 general practices in Oxfordshire and South Yorkshire.
                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%.
                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).
                HbA1c level measured at 12 months.
                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%).
                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.
                Current Controlled Trials ISRCTN47464659. Whether self-monitoring of blood glucose (SMBG) improves glycaemic control in patients with type 2 diabetes mellitus (T2DM) not using insulin is questionable. Our aim was to investigate the effects of SMBG in patients with T2DM who were in persistent moderate glycaemic control whilst not using insulin.
                Patients were eligible when between 18 and 70 years of age, with an HbA1c between 7 and 8.5%, using one or two oral blood glucose lowering agents. Forty-one of the anticipated 52 patients were randomly assigned to receive either SMBG added to usual care, or to continue with usual care for one year. A fasting glucose value and three postprandial glucose values were measured twice weekly (including a Saturday or a Sunday). The primary efficacy parameter was HbA1c. Furthermore, health-related quality of life and treatment satisfaction were assessed using the Short-form 36 Health Survey Questionnaire (SF-36), the Type 2 Diabetes Symptom Checklist (DSC-r), the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the WHO -Wellbeing Index (WHO-5).
                Change in HbA1c between groups was -0.05% (95% CI: -0.51, 0.41; p=0.507). Also, there were no significant changes between groups on the DTSQ , DSC type 2, WHO-5 or SF -36, except for the SF -36 dimension 'health change' which was lower in the SBMG group (mean difference: -12 (95% CI: -20.9, -3.1).
                On top of the absence of a clinical benefit, tablet-treated T2DM patients experienced some worsening of their health perception. We therefore argue that the use of SMBG in this patient group is questionable, and its unlimited use and promotion should be reconsidered. Self-monitoring of blood glucose (SBGM) is widely recommended for both type 1 and type 2 diabetic patients despite the lack of evidence of benefit in glucose control or as an aid in weight loss in type 2 subjects. This study tested the hypothesis that combined use of SMBG and dietary carbohydrate (CHO) counting, using the blood monitoring results to shape dietary CHO quotas, is beneficial in managing type 2 diabetes. Twenty-three overweight (body mass index, BMI 27.5-44 kg/m2) patients aged 40-75 participated in a 28-week behavioral weight control program. Baseline hemoglobin HbA1c ranged between 9.5% and 13.5% (normal range 5.5%-7.7%). Subjects were matched for weight, sex, and HbA1c and assigned to small (4-8 participants) groups which met weekly for 12 weeks and then monthly for 16 weeks. After 8 weeks, the groups were randomized either to continue the behavioral program or to have SMBG and dietary CHO counting. Glucose monitoring was performed 6 times daily (pre- and 2 h postprandially) for the first month, focusing on the meal increment and correlating this to dietary CHO intake. Weight loss was identical in both groups during the year of follow-up. The HbA1c level showed a progressive decline in experimental subjects (P < 0.05), whereas there was no improvement in control subjects. To show improved glycemic control in patients with insulin-treated diabetes after adjustments to the diabetes management plan based on either continuous glucose monitoring using the Continuous Glucose Monitoring System (CGMS) or frequent self-monitoring of blood glucose (SMBG) using a home blood glucose meter.
                From January to September 2000, patients aged 19 to 76 years with insulin-treated diabetes were assigned to insulin therapy adjustments based on either CGMS or SMBG values. At the end of the study, patients in both groups used the CGMS for 3 days; these values were used to calculate measures of hypoglycemia. Repeated-measures analysis of variance with post hoc comparisons were used to test differences in hemoglobin A1c levels and hypoglycemia between the 2 study groups.
                A total of 128 patients were enrolled in the study. Nineteen discontinued study participation, leaving 51 in the CGMS group and 58 in the SMBG group. No significant differences were noted in demographics or baseline characteristics between the 2 groups. There were no significant differences in hemoglobin A1c levels between the CGMS group and the SMBG group at baseline (9.1% +/- 1.1% vs 9.0% +/- 1.0%, P = .70), and both groups showed statistically significant (P < .001) and similar (P = .95) improvement in hemoglobin A1c levels after 12 weeks of study. However, the CGMS group had a significantly shorter duration of hypoglycemia (sensor glucose, < or = 60 mg/dL) at week 12 of the study (49.4 +/- 40.8 vs 81.0 +/- 61.1 minutes per event, P = .009).
                Use of the CGMS to guide therapy adjustments in patients with insulin-treated diabetes reduces the duration of hypoglycemia compared with therapy adjustments guided by SMBG values alone. The aim of this study was to examine whether a nurse-administered minimal psychological intervention for depressive symptoms improves diabetes-specific quality of life and glycaemic control in older persons with diabetes.
                Depression is common among persons with diabetes and may have a negative impact on diabetes. Interventions aimed at reducing depressive symptoms may positively influence diabetes-specific quality of life as well.
                A pragmatic, randomized controlled trial was carried out comparing the intervention with usual care among 208 Dutch primary care patients of ≥60 years with type 2 diabetes and co-occurring minor to moderate depression. Data on symptom distress and emotional distress were collected during 2003-2006, and haemoglobin A1c levels were obtained from general practices. Data were analysed using mixed model, repeated measures ANCOVAS. Hba1c was collected retrospectively from general practices between December 2006-February 2007. In July 2007 we retrieved some additional HbA1c data from the medical records of the university hospital.
                Only in higher-educated persons did the intervention have statistically significant effect on both emotional distress and symptom distress (DSC-R total score at 9 months P=0.001; PAID, 9 months P=0.03). Furthermore, we found an effect on symptom distress in men (9 months P=0.01), and on emotional distress in persons with a shorter diabetes duration (<7 years) (9 months P=0.04). A significant trend over time for haemoglobin A1c was found in favour of the intervention, with a statistically significant difference between groups after 9 months (P=0.02).
                The nurse-administered intervention had limited effects on diabetes-specific quality of life. As only certain subgroups benefited, ways of increasing effectiveness in other groups should be explored. The potentially beneficial effect on glycaemic control is encouraging and needs further research because of small numbers in the analysis.
                © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd. This randomized controlled trial assesses the effect on glycemic control of continuous glucose monitoring system (CGMS)-guided insulin therapy adjustment in young people with type 1 diabetes on intensive diabetes treatment regimens with continuous subcutaneous insulin infusion (CSII) or glargine.
                Pediatric subjects were recruited if they had an HbA(1c) (A1C) <10% and had been on CSII or glargine for at least 3 months. Thirty-six subjects were randomized to insulin adjustment on the basis of 72 h of CGMS every 3 weeks or intermittent self-monitoring of blood glucose (SMBG) for 3 months. A1C and fructosamine were measured at baseline and 6 and 12 weeks. Follow-up A1C was measured at 6 months. Mean baseline A1C was 8.2% (n = 19) in the CGMS group and 7.9% (n = 17) in the control group.
                There was a significant improvement in A1C from baseline values in both groups, but there was no difference in the degree of improvement in A1C at 12 weeks between the CGMS (-0.4% [95% CI -0.7 to -0.1]) and the control group (-0.4% [-0.8 to 0.2]). In the CGMS group, improved A1C was at the cost of increased duration of hypoglycemia.
                CGMS is no more useful than intermittent fingerstick SMBG and frequent review in improving diabetes control in reasonably well-controlled patients on near-physiological insulin regimens when used in an outpatient clinic setting. To determine if therapeutic management programmes for type 2 diabetes that include self-monitoring of blood glucose (SMBG) result in greater reductions in glycated haemoglobin (HbA1c) compared with programmes without SMBG in non-insulin requiring patients.
                Multicentre, randomized, parallel-group trial. A total of 610 patients were randomized to SMBG or non-SMBG groups. Patients in both groups received the same oral antidiabetic therapy using a gliclazide modified release (MR)-based regimen for 27 weeks. The primary efficacy end-point was the difference between groups in HbA1c at the end of observation.
                A total of 610 patients were randomized: 311 to the SMBG group and 299 to the non-SMBG group. HbA1c decreased from 8.12 to 6.95% in the SMBG group and from 8.12 to 7.20% in the non-SMBG group; between-group difference was 0.25% (95% CI: 0.06, 1.03; p = 0.0097). Symptoms suggestive of mild to moderate hypoglycaemia was the most commonly reported adverse event, reported by 27 (8.7%) and 21 (7.0%) patients in the SMBG and non-SMBG groups, respectively; the incidence of symptomatic hypoglycaemia was lower in the SMBG group.
                In patients with type 2 diabetes, the application of SMBG as an adjunct to oral antidiabetic agent therapy results in further reductions in HbA1c. Self monitoring of blood glucose (SMBG) in type 2 diabetes is a topic of current interest (imbalance between increased health-care costs and improvement in compliance with treatment and diet). An open label randomized prospective study was designed to compare changes in metabolic control over 6 months in patients managed with usual recommendations alone (conventional assessment group) or combined with SMBG.
                Patients not treated with insulin or previously self monitored, 40 to 75 years of age, with a diagnosis of type 2 diabetes > 1 year and standardized HbA(1c) level > =7.5 and< =11% were randomized to either a control group or SMBG group. They were followed up every 6 weeks over 24 weeks. Patients in the SMBG group were given the same device (Ascensia Esprit Discmeter, Bayer) and were required to perform at least 6 capillary assays a week (3 different days of the week, including weekend). Management of patients was standardized, including drugs, diet and physical activity. The primary efficacy criterion was change in HbA(1c) level in Intent To Treat (ITT) patients. Assays were performed at baseline, at 3 and 6 months using the calibrated DCA 2000(R) device (Bayer).
                Two hundred sixty five general practitioners randomized 988 patients (ITT Population), but 689 patients were evaluable for the primary criterion. At the endpoint, HbA(1c) was lower in the SMBG group (8.1 +/- 1.6%) than in the conventional treatment group (8.4 +/- 1.4%, P=0.012). The change in HbA(1c) levels between baseline and endpoint was classified into two classes: improvement if a change > 0.5% occurred, stability or worsening in case of a change< =0.5%; 57.1% of patients in the SMBG group vs 46.8% in the control group had an improvement in HbA(1c) level (P=0.007) after 3 months. A steady state was reached during the last 3 months. A multivariate logistic regression analysis was performed and identified factors predictive of improvement in HbA(1c) levels: HbA(1c) at baseline: odd ratio (OR)=1.749 (P<0.001), SMBG group (reference value: SMBG group): OR=0.665 (P=0.015), duration of diabetes: OR=0.953 (P=0.001) and BMI: OR=0.962 (P=0.039).
                This study is the first multicenter, controlled, prospective trial conducted on a large number of patients demonstrating that SMBG was statistically associated with a better quality of metabolic control than usual traditional recommendations alone in type 2 diabetes. To study the feasibility and the influence on glycaemic control of continuous glucose monitoring (CGMS) in young patients with type 1 diabetes.
                A double-blinded, cross-over study was performed in 30 children (median age 11.1 years [range: 2.3 - 16.3], diabetes duration 2.1 years [0.2 - 7.1]). Patients were randomised into an open (A) or blind study arm (B). Both groups performed standardised self-monitoring blood glucose (SMBG) and received CGMS at the beginning of the study, at 3 and 6 months, each. In the blinded arm, patients and investigator were concealed from CGMS data. After 3 months, open and blinded study arms crossed over. Average glucose values and area under the glucose curve (AUC) per 24 h, above 180 and below 60 mg/dl were calculated from CGMS. Haemoglobin A1c (HbA1c) was measured at each study point.
                Despite comparable clinical characteristics between the 15 patients of each arm, mean HbA1c was slightly lower in arm A than in B at baseline (7.8 +/- 1.2 % vs. 8.4 +/- 1.1 %, p = 0.148), at 3 months (7.8 +/- 1.1 % vs. 8.3 +/- 1.1 %, p = 0.233), and significantly lower at 6 months (7.6 +/- 1.1 % vs. 8.5 +/- 0.9 %, p = 0.026). However, no significant change of HbA1c occurred within each arm (A, p = 0.183 and B, p = 0.823), irrespectively whether CGMS data were blinded or not. Likewise, mean glucose and hyper- or hypoglycaemia values did not change significantly.
                In this setting, CGMS did not decisively influence glycaemic control of a total study cohort. More frequent use of CGMS at shorter intervals in single patients with hyper- or hypoglycaemic problems may be of greater value than SMBG. Few studies have demonstrated an effect of educational interventions on glycaemic control in persons with Type 2 diabetes longer than 3-6 months after baseline. We aimed to investigate the effectiveness of an experience-based group educational programme 24 months after baseline and to pinpoint mediators that might play a role in achieving desired metabolic outcomes. We conducted a randomised controlled trial inviting self-referred persons with Type 2 diabetes (N=77 randomised). The pharmacist-led, year-long intervention was based on participants' experiences of glucose regulation during the monthly group discussions. We measured HbA1c at 0, 6, 12, and 24 months and a questionnaire was administered at baseline and final follow-up. Our findings indicated that participating in the intervention programme significantly decreased HbA1c by 0.4% at 24 months after baseline. Initial HbA1c, satisfaction with own diabetes-related knowledge, and treatment were found directly related to glycaemic outcomes. The intervention group exercised more in order to lower blood-glucose levels and was also more able to predict current blood-glucose levels before measuring it. Experience-based group education was effective in decreasing participants' HbA1c 1-year after completed intervention. Early effect of the intervention was followed by relapse after 12 months and a new, significant decrease at 24 months; this dual course implies that follow-up of educational interventions should involve several consecutive measurements to capture possible late effects. Both biomedical and subjective factors played a role in accounting for the variance of HbA1c at 2-year follow-up after baseline. To improve quality and efficiency of care for elderly patients with type 2 diabetes, we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare (u-healthcare) service, which is an individualized health management system using advanced medical information technology.
                We conducted a 6-month randomized, controlled clinical trial involving 144 patients aged >60 years. Participants were randomly assigned to receive routine care (control, n = 48), to the self-monitored blood glucose (SMBG, n = 47) group, or to the u-healthcare group (n = 49). The primary end point was the proportion of patients achieving A1C <7% without hypoglycemia at 6 months. U-healthcare system refers to an individualized medical service in which medical instructions are given through the patient's mobile phone. Patients receive a glucometer with a public switched telephone network-connected cradle that automatically transfers test results to a hospital-based server. Once the data are transferred to the server, an automated system, the CDSS rule engine, generates and sends patient-specific messages by mobile phone.
                After 6 months of follow-up, the mean A1C level was significantly decreased from 7.8 ± 1.3% to 7.4 ± 1.0% (P < 0.001) in the u-healthcare group and from 7.9 ± 1.0% to 7.7 ± 1.0% (P = 0.020) in the SMBG group, compared with 7.9 ± 0.8% to 7.8 ± 1.0% (P = 0.274) in the control group. The proportion of patients with A1C <7% without hypoglycemia was 30.6% in the u-healthcare group, 23.4% in the SMBG group (23.4%), and 14.0% in the control group (P < 0.05).
                The CDSS-based u-healthcare service achieved better glycemic control with less hypoglycemia than SMBG and routine care and may provide effective and safe diabetes management in the elderly diabetic patients.
From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications.