Self-monitoring Of Blood Glucose Results Research Articles

The Efficacy and Frequency of Self-monitoring of Blood Glucose in Non-insulin-Treated T2D Patients: a Systematic Review and Meta-analysis.

Self-monitoring of blood glucose (SMBG) is a useful tool in diabetes management, but its efficacy and optimal application in type 2 diabetes (T2D) patients treated without insulin have been controversial. We aimed to evaluate the efficacy of SMBG in controlling blood glucose levels in non-insulin-treated T2D patients and to determine the optimal frequency and the most appropriate population to benefit from SMBG. Eligible publications from January 2000 to April 2022 were retrieved from PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases. Randomized controlled trials comparing SMBG with no SMBG or structured SMBG (S-SMBG, SMBG with defined timing and frequency of glucose measurements) were included. Meta-analyses and sub-analyses were performed to assess the efficacy, optimal frequency, and most appropriate population for SMBG. Risk of bias was assessed regarding randomization, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases. Twenty-two studies involving 6204 participants were identified, including 17 comparing SMBG with no SMBG and 4 comparing SMBG with S-SMBG. SMBG reduced HbA1c (MD -0.30%, 95% CI -0.42 to -0.17) compared with no SMBG, and S-SMBG performed better than SMBG (MD -0.23%, 95% CI -0.38 to -0.07). Subgroup analyses showed that HbA1c control was better with SMBG at 8-11 times weekly (MD -0.35%, 95% CI -0.51 to -0.20) compared with other frequencies and with lifestyle adjustments (MD -0.37%, 95% CI -0.50 to -0.23) than with no adjustments. No significant differences in HbA1c were observed between baseline HbA1c subgroups (≤ 8% and > 8%, P = 0.63) and between diabetes duration subgroups (≤ 6 years and > 6 years, P = 0.72), respectively. SMBG was effective for controlling HbA1c in non-insulin-treated T2D patients, although lacking detailed monitoring design. Better outcomes were seen with SMBG at 8-11 times weekly and lifestyle adjustment based on SMBG results. PROSPERO (CRD42021285604).

Blood Glucose Monitoring and Sharing Amongst People With Diabetes and Their Facilitators: Cross-sectional Study of Methods and Practices

BackgroundThe last two decades have witnessed a burgeoning rise in the prevalence of diabetes globally. It has already reached epidemic proportions in Saudi Arabia, with reported high risk among women. As a result, diabetes monitoring and self-management programs are being highly prioritized for diabetes control and management.ObjectiveTo investigate measuring and sharing practices of the self-monitoring of blood glucose (SMBG) among patients with type 1 or 2 diabetes using insulin.MethodsA cross-sectional study was conducted on a sample of 203 patients attending primary care clinics at a tertiary care center. The questionnaire assessed the measuring, recording, and sharing of SMBG practices of patients having diabetes with their physicians. The methods used for recording and sharing were categorized into paper-based and electronic-based. In addition, the determinants of the different methods used and frequency of sharing were analyzed.ResultsThe overall monitoring prevalence was 95% (193/203), and 57% (117/203) of participants shared the SMBG results. Among the 193 individuals that performed self-monitoring, 138 (72%) performed daily monitoring, and 147 (76%) recorded their blood sugar levels. Almost 55% (81/147) used paper-based materials like notebooks and paper for recording, while the rest (66/147, 45%) used digital devices like laptops and smartphones. A shift towards the use of digital devices and smart applications was observed in patients below 50 years of age. The digitally recorded blood glucose measurements were being shared thrice more often than the recordings made on paper or in notebooks (OR [odds ratio] 2.8; P=.01). Patients >50 years of age (OR 2.3; P=.02), with lesser formal education, married (OR 4.2; P<.001), with smaller family size (OR 2.6; P=.01), having type 2 diabetes (OR 4.1; P<.001) and any comorbid conditions (OR 2.6; P=.01) were associated with higher odds of using paper-based sharing methods. Only the female gender and type 2 diabetes were associated with increased frequency of sharing, while uncontrolled diabetes, the presence of other comorbidities, and duration of diabetes did not show any influence.ConclusionsGood monitoring and optimal sharing practices were found. Sharing using electronic devices can be emphasized. Diabetes self-management programs can incorporate the use of digital technology in training sessions. Digital literacy and its applications in health care may enhance SMBG practices resulting in better diabetes control.

Real-world data from Europe and Africa suggest that accuracy of systems for self-monitoring of blood glucose is frequently impaired by low hematocrit

AimsCertain systems for self-monitoring of blood glucose (SMBG) demonstrate inaccuracy at low and high hematocrit (HCT). Manufacturers define HCT ranges for accurate performance. Our objective was to assess the frequency of HCT values that can lead to clinically relevant errors. MethodsIn this cross-sectional study, we collected real-world data representing over 360,000 outpatients from the Netherlands (NL), the Czech Republic (CZ), and South Africa (ZA). These were subsequently stratified by sex and age and compared to commonly specified HCT range limits, reference intervals, and data from 1780 healthy Czech subjects. ResultsHCT values were comparably distributed in NL and CZ. Outpatients had a higher dispersion of values than healthy subjects. Low HCT values in Europe were common in age groups with a high prevalence of diabetes. All ZA age groups showed a higher prevalence of low HCT than in Europe. ConclusionsReal-world data indicate that SMBG systems specified to perform only within the frequently used 30–55% HCT range would leave 3% of outpatients in Europe and 18% in South Africa at risk of false SMBG results, with individual age strata being substantially higher. This could affect their diabetes management. Adequate SMBG systems should thus be chosen.

Hypoglycaemia on an oral glucose tolerance test in pregnancy – Is it clinically significant?

AimDuring pregnancy, some women have a low glucose level on the 75 g oral glucose tolerance test (OGTT). The implications of this are unclear and there is no guideline on how to manage these women. MethodWe recruited pregnant women with a glucose level <3.5 mmol/L at 1- or 2-h during a screening antenatal OGTT. These women (Group 1) underwent self-monitoring of blood glucose (SMBG) over a two-week period. We also compared Group 1′s demographic and pregnancy outcomes data with women who had normal OGTT results (Group 2) and women diagnosed with gestational diabetes mellitus (GDM) (Group 3). Results52 women were recruited. Post-hoc analysis of the SMBG results revealed 50% of women experienced 2 or more elevated fasting BGLs (>5.1 mmol/L) in a week when using the Australian Diabetes in Pregnancy Society (ADIPS) criteria. A further 8% women had elevated 2-h glucose levels (above 6.7 mmol/L). Group 1 women tended to have higher booking weight. They were less likely to have a history of macrosomia or be of East or South-East Asian ethnicity. There were no differences in pregnancy outcomes between Groups 1 and 2, but Group 1 had a higher rate of congenital abnormality (6%) than Group 3 (2%). ConclusionA large proportion of pregnant women who had a low glucose level on OGTT had elevated glucose levels on SMBG, however their pregnancy outcomes were not significantly different to women who had a normal OGTT. Currently there is not enough evidence to advocate routine SMBG and treatment for this group of women.

Positive Impact of a Pilot Pharmacist-Run Diabetes Pharmacotherapy Clinic in Solid-Organ Transplant Recipients.

Purpose.Post-transplant diabetes mellitus (PTDM) can lead to significant morbidity and cardiovascular death with a functioning graft. A paucity of literature exists regarding glycemic control in solid-organ transplant (SOT) recipients, including pharmacist management of PTDM. This study aimed to assess the impact of pharmacist interventions on diabetes management in a pharmacist-run PTDM clinic.Methods.This was a single-center, prospective, observational study of 24 adult SOT recipients enrolled in a pilot pharmacist-managed PTDM clinic from 1 January to 30 June 2015.Results.Improvements were realized in markers of glycemic control, including changes in A1C, average daily self-monitoring of blood glucose (SMBG) results, fasting SMBG results, and pre-lunch SMBG results from enrollment through at least 3 months of follow-up. Median A1C decreased significantly from 8.05% (interquartile range [IQR] 6.33–11.75) at baseline to 6.45% (IQR 6.05–7.3) at the last follow-up encounter (P = 0.0010). Average daily SMBG results decreased significantly from a median of 191 mg/dL (IQR 138–232 mg/dL) at baseline to 125 mg/dL (IQR 111–167 mg/dL) at the final encounter (P = 0.0023). Median fasting and pre-lunch SMBG results decreased significantly from 153 mg/dL (IQR 117–208 mg/dL) at baseline to 120 mg/dL (IQR 102–134 mg/dL) (P = 0.0064) and from 212 mg/dL (IQR 159–258 mg/dL) to 122 mg/dL (IQR 110–169 mg/dL) (P = 0.0161), respectively. Changes from baseline in other SMBG values, lipid levels, and BMI were not statistically significant.Conclusion.The results of our study demonstrate that a pharmacist-managed PTDM clinic can significantly affect glycemic control in SOT recipients.

Empowerment-Based Diabetes Self-Management Education to Maintain Glycemic Targets During Ramadan Fasting in People With Diabetes Who Are on Conventional Insulin: A Feasibility Study

Objective.This study aims to assess the feasibility of promoting safe Ramadan fasting through diabetes self-management education (DSME) and to determine the effect of such education on hypoglycemic episodes.Design and methods.This prospective study included subjects attending Ramadan reinforcement sessions for participants in the Educational Program for People with Diabetes (EPPWD) at the Ain-Shams University Diabetes Center in Cairo, Egypt. The DSME sessions started 2–3 weeks before Ramadan and included one experimental fasting day during the first week and one during the second week. Participants’ A1C and serum fructosamine levels were measured before and after Ramadan, and they completed weekly self-monitoring of blood glucose (SMBG) logs.Results.Among 21 participants who were intending to fast for Ramadan, 14 completed the program. Their mean A1C was 6.7 ± 1.6%, and SMBG results showed a statistically nonsignificant difference in mean blood glucose levels before and after Ramadan (123.84 ± 39.96 and 123.84 ± 25.92 mg/dL, respectively; P >0.05). Serum fructosamine after Ramadan declined by 10% from pre-Ramadan levels. The mean number of hypoglycemic events before Ramadan was 3 ± 1.04, which declined to 1.4 ± 0.5 during Ramadan. Differences between group 1 (those without hypoglycemia, n = 8) and group 2 (those with hypoglycemia, n = 6) were nonsignificant for all variables, including A1C.Conclusion.Ramadan fasting is feasible for people with diabetes who are on a multiple daily injection insulin regimen and participate in the EPPWD. The number of hypoglycemic events per month declined with the attainment of DSME.

A New Test Strip Technology Platform for Self-Monitoring of Blood Glucose

In the management of diabetes, accuracy of devices used for self-monitoring of blood glucose (SMBG) is critical because SMBG results can affect patient diabetes-related health outcomes. A new blood glucose monitoring system (BGMS) platform has been developed that is based on the new CONTOUR® NEXT (CN) test strip. This BGMS platform uses a proprietary electron mediator and algorithm to minimize errors at different steps in the testing process, thus minimizing outliers and significantly improving accuracy from prior-generation blood glucose meter systems. As demonstrated by questionnaire results from clinical studies with the new BGMS platform, accuracy and ease of use are important considerations for people with diabetes and their health care professionals when selecting an SMBG device. This article provides an overview of laboratory studies and clinical trials in the hands of lay users involving the performance of the portfolio of blood glucose meters that uses the new test strip. Each BGMS in the platform, which includes the CONTOUR XT (CONTOUR NEXT EZ in the United States), CONTOUR NEXT LINK, CONTOUR NEXT USB, and CN systems, demonstrated advanced accuracy both in the laboratory and in the hands of subjects (people with diabetes) and trained health care professionals. All systems met and exceeded International Organization for Standardization accuracy criteria (both ISO 15197:2003 and ISO 15197:2013). Each system in the new BGMS platform delivers advanced accuracy, which is essential to people who utilize SMBG for improved management.

Self-monitoring of blood glucose

Self-monitoring of blood glucose

A survey of blood glucose monitoring in patients with type 2 diabetes: are recommendations from health care professionals being followed?

Objective:To survey the self-reported use of self-monitoring of blood glucose (SMBG) among patients with type 2 diabetes (T2DM), both insulin users (IUs) and non-insulin users (NIUs), in the United States and to examine: how often patients test; what SMBG instructions patients report receiving from their health care providers (HCPs); how the frequency of testing conforms with reported HCP recommendations for testing; and what is done with the results of testing. Differences between IUs and NIUs were also investigated.Methods:A convenience sample of 886 T2DM participants at a series of one-day conferences across the United States completed a survey on current and recommended SMBG frequency, how SMBG results were used, and how HCPs reportedly talked about SMBG issues with the patient. IUs (65% of the sample) and NIUs (35%) were examined separately.Results:IUs and NIUs reported testing significantly less frequently than was recommended (in both cases, p < 0.001), with wide variations within both groups. Many IUs (42%) and NIUs (50%) did not bring SMBG data regularly to medical visits, and 54% of IUs and 56% of NIUs did not respond regularly to out-of-range SMBG readings. HCPs were generally supportive and responsive to SMBG data. More frequent SMBG was associated with more regular HCP attention to SMBG records, for IUs (p = 0.02) and NIUs (p = 0.004).Conclusions:Self-reported SMBG use is common in T2DM, though frequency is lower than HCP recommendations. Wide variations in actual and recommended SMBG were observed. HCP support for SMBG is reportedly common, and is associated with greater SMBG frequency. While SMBG data can be valuable, recommendations are often not followed and data often goes unused by both HCPs and patients.

The relationship between self-monitoring of blood glucose results and glycated haemoglobin in type 2 diabetes: The Fremantle Diabetes Study

The benefits of self-monitoring of blood glucose (SMBG) in type 2 diabetes remain contentious. If SMBG data do not accurately reflect HbA1c, attempts to modify lifestyle/pharmacotherapy will be ineffective. We aimed to determine how well SMBG correlates with HbA1c and fasting serum glucose (FSG). Community-based type 2 patients using SMBG provided their highest and lowest pre- and post-prandial glucose results in the week before detailed assessment. The ability of average pre- and post-prandial SMBG to predict HbA1c>7.0% was determined by linear regression and receiver operating characteristic (ROC) analyses. Of 1286 patients with known SMBG status, 70% reported using SMBG. Pre-prandial SMBG data were obtained from 554 participants and post-prandial SMBG data from 418. The mean SMBG result and HbA1c correlated significantly (pre-prandial rs=0.55, post-prandial rs=0.47; P<0.001). Areas under the ROC curve (95% confidence limits) were 0.78 (0.74–0.83) and 0.74 (0.69–0.78) for pre- and post-prandial SMBG (P<0.04). The optimal cut-point was 6.5mmol/L for pre-prandial SMBG (sensitivity 79.3%, specificity 64.4%). Mean pre-prandial SMBG results correlated with FSG (rs=0.64, P<0.001) but were on average 1.4mmol/L lower, consistent with known whole blood vs. plasma differences. Since SMBG values reflect prevailing glycaemia, refinements in their interpretation and application may improve SMBG effectiveness.

Rapid Improvement of Glycemic Control in Type 2 Diabetes Using Weekly Intensive Multifactorial Interventions: Structured Glucose Monitoring, Patient Education, and Adjustment of Therapy—A Randomized Controlled Trial

We evaluated intensive intervention in poorly controlled patients with type 2 diabetes mellitus involving weekly clinic visits and adjustment of therapy with analysis of three seven-point glucose profiles and intervention from an interdisciplinary staff. Sixty-three patients were randomized to an intensive treatment group that obtained self-monitoring of blood glucose (SMBG) profiles (six or seven values per day, 3 days/week) and were seen in the clinic at Weeks 1-6 and 12. SMBG results were downloaded, analyzed using Accu-Chek(®) 360° software (Roche Diagnostics, Indianapolis, IN), and used to adjust therapy. Control group subjects obtained glucose profiles and had clinic visits only at Weeks 0, 6, and 12. There were highly statistically significant improvements in the intensive treatment group compared with the control group between Weeks 0 and 6 with greater reductions in weekly mean glycemia (WMG) (-76.7±8.9 mg/dL vs. -20.5±8.1 mg/dL), glycemic variability (SD) (-16.3±3.1 mg/dL vs. -5.0±3.1 mg/dL), and glycated hemoglobin (-1.82±0.16% vs. -0.66±0.22%) without significant changes in frequency of hypoglycemia or weight. Improvements were sustained in the intensive treatment group through Week 12. A minimal but statistically significant degree of improvement was seen in the control group at Week 12. This short-term pilot study of an intensive monitoring, educational, and pharmacological interventions program resulted in dramatic improvement of glycemic control within 6 weeks, and these effects are sustained through Week 12. SMBG glucose profiles, calculation of WMG and SD, and graphical displays of glucose data can improve the effectiveness of adjustment of therapy at weekly clinic visits when combined with intensive support from a multidisciplinary team.

ROSES: role of self‐monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial

To estimate the efficacy of a self-monitoring-based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy. This was an open-label, randomized, pilot study, primarily led by diabetes nurses. Patients were randomly allocated to either a self-monitoring-based disease management strategy or usual care (ratio 3:1) and followed up for 6 months. Education was centred on how to modify lifestyle according self-monitoring readings. Self-monitoring of blood glucose results were discussed during monthly telephone contact. The primary endpoint was mean change in HbA(1c) levels, estimated with an ANOVA for repeated measures. All analyses were intention to treat. Three diabetic clinics recruited 62 patients, of whom five were lost to follow-up. At baseline, both groups had a mean HbA(1c) value of 7.9% ± 0.6% (63 ± 6 mmol/mol). After 6 months, mean HbA(1c) reduction was 1.2 ± 0.1% (-13 ± 1 mmol/mol) in the intervention group and 0.7 ± 0.2 (-8 ± 2 mmol/mol) in the control group, with an absolute mean difference between groups of -0.5% (95% CI -0.9 to -0.0%; P = 0.04) (-5 mmol/mol, 95% CI -10 to 0). At study end, 61.9% of patients in the intervention group and 20.0% in the control group reached the target level of HbA(1c) < 7.0% (< 53 mmol/mol) (P = 0.005). Body weight reduction was significantly greater in the intervention group than in the control group (between-group absolute mean difference: -3.99 kg; 95% CI -7.26 to -0.73; P = 0.02). Therapy changes were more frequent in the control group. A self-monitoring disease management strategy, primarily led by diabetes nurses and allowing a timely and efficient use of self-monitoring readings, is able to improve metabolic control, primarily through lifestyle modifications leading to weight loss.

A Structured Self-Monitoring of Blood Glucose Approach in Type 2 Diabetes Encourages More Frequent, Intensive, and Effective Physician Interventions: Results from the STeP Study

We evaluated how a structured patient/physician self-monitoring of blood glucose (SMBG) intervention influenced the timing, frequency, and effectiveness of primary care physicians' treatment changes with type 2 diabetes mellitus (T2DM) patients over 12 months. The Structured Testing Program (STeP) study was a cluster-randomized, multicenter trial with 483 poorly controlled, insulin-naive T2DM subjects. Primary care practices were randomized to the Active Control Group (ACG) or the Structured Testing Group (STG), the latter of which included quarterly review of structured SMBG results. STG patients used a paper tool that graphs seven-point glucose profiles over 3 consecutive days; physicians received a treatment algorithm based on SMBG patterns. Impact of structured SMBG on physician treatment modification recommendations (TMRs) and glycemic outcomes was examined. More STG than ACG patients received a TMR at each study visit (P < 0.0001). Of patients who received at least one TMR, STG patients demonstrated a greater reduction in glycated hemoglobin A1c (HbA1c) than ACG patients (-1.2% vs. -0.8%, P < 0.03). Patients with a baseline HbA1c ≥8.5% who received a TMR at the Month 1 visit experienced greater reductions in HbA1c (P = 0.002) than patients without an initial TMR. More STG than ACG patients were started on incretins (P < 0.01) and on thiazolidinediones (P = 0.004). The number of visits with a TMR was unrelated to HbA1c change over time. Patient-provided SMBG data contribute to glycemic improvement when blood glucose patterns are easy to detect, and well-trained physicians take timely action. Collaborative use of structured SMBG data leads to earlier, more frequent, and more effective TMRs for poorly controlled, non-insulin-treated T2DM subjects.

Self-monitoring of blood glucose

Many would argue that the introduction of modern-day diabetes management started 30 years ago with the introduction of self-monitoring of blood glucose (SMBG) at home. While that may be true, it is interesting that many of today’s fundamental questions have yet to be answered. Furthermore, the technology itself continues to change, to improve and to better exist with our non-diabetes technology. For example, the first SMBG ‘apps’ are available now for smart-phones (iPhone), and we can expect the phones themselves to participate more directly with SMBG and diabetes management. Still, both researchers (and payors) continue to ask some fundamental questions. 1 What is the efficacy of SMBG for patients not requiring insulin therapy? 2 What is the optimum frequency of SMBG for patients who do require insulin therapy? 3 What is the role of software to assist in data management for SMBG (for both patients and clinicians)? 4 What is the cost effectiveness of SMBG for all of the different patient populations with diabetes? 5 What is the ideal chemistry which results in the least amount of interfering substances with SMBG? 6 What is an acceptable accuracy for SMBG both at home and in the hospital? The accuracy question is more important than ever since all continuous glucose monitoring (CGM) for now are calibrated with SMBG results. 7 What is the best strategy for teaching patients how best to use their SMBG data? 8 What is the best way to integrate SMBG with insulin pump therapy? 9 What is the role of SMBG with today’s CGM devices? 10 What will the role of SMBG be 5–10 years from now with future CGM devices? These are just some of the questions which need more thought and study as we move into 2011. In this chapter we have selected papers that appeared in the PubMed on this topic and chose those we thought were most influential in this area. We have then addressed many of these topics although answers are far from clear for many of them. Although SMBG is not ‘new’ technology, much research needs to be completed before we fully understand this tool’s full impact, particularly as CGM becomes more popular.

Self-Monitoring of Blood Glucose: What Are Healthcare Professionals Recommending?

ABSTRACT OBJECTIVE: The clinical benefit and cost-effectiveness of self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes not using insulin has been questioned. The objective of this study was to gain insight into healthcare professionals' recommendations, practices and beliefs with respect to SMBG in well-controlled adults (glycated hemoglobin ≤7.0%) with type 2 diabetes not using insulin. METHODS: Interviews were conducted with diabetes educators, pharmacists and family physicians in 3 district health authorities in Nova Scotia, Canada. Audiotaped interviews were transcribed and analyzed using a thematic analysis approach. RESULTS: All participants recommended SMBG for persons in this population. Recommendations varied both within and between professional groups and were noted to be highly individual. SMBG results were perceived to be valuable for both patients and healthcare professionals. Participants identified clinical practice guidelines as a trustworthy source of information about SMBG in this population. CONCLUSION: Guidelines cite a lack of substantial evidence for SMBG in this population. Customized SMBG practices are important, but so are clarity and consistency in guideline recommendations. Reducing the use of SMBG in patient populations where it is unlikely to be beneficial will allow reallocation of resources to interventions with proven benefit.

Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial

to evaluate the efficacy and safety of adding sitagliptin or glimepiride to the treatment regimen of patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin monotherapy. patients with type 2 diabetes and an HbA(1c) of 6.5-9.0% while on a stable dose of metformin (≥ 1500 mg/day) combined with diet and exercise for at least 12 weeks were randomized in a double-blind manner to receive either sitagliptin 100 mg daily (N = 516) or glimepiride (starting dose 1 mg/day and up-titrated, based upon patient's self-monitoring of blood glucose results, to a maximum dose of up to 6 mg/day) (N = 519) for 30 weeks. The primary analysis assessed whether sitagliptin is non-inferior to glimepiride in reducing HbA(1c) at week 30 (based on the criterion of having an upper bound of the 95% CI less than the prespecified non-inferiority bound of 0.4%). the mean baseline HbA(1c) was 7.5% in both the sitagliptin group (n = 443) and the glimepiride group (n = 436). After 30 weeks, the least squares (LS) mean change in HbA(1c) from baseline was -0.47% with sitagliptin and -0.54% with glimepiride, with a between-group difference (95% CI) of 0.07% (-0.03, 0.16). This result met the prespecified criterion for declaring non-inferiority. The percentages of patients with an HbA(1c) < 7.0% at week 30 were 52 and 60% in the sitagliptin and glimepiride groups, respectively. The LS mean change in fasting plasma glucose from baseline (95% CI) was -0.8 mmol/l (-1.0, -0.6) with sitagliptin and -1.0 mmol/l (-1.2, -0.8) with glimepiride, for a between-group difference (95% CI) of 0.2 mmol/l (-0.1, 0.4). The percentages of patients for whom hypoglycaemia was reported were 7% in the sitagliptin group and 22% in the glimepiride group (percentage-point difference = -15, p < 0.001). Relative to baseline, sitagliptin was associated with a mean weight loss (-0.8 kg), whereas glimepiride was associated with a mean weight gain (1.2 kg), yielding a between-group difference of -2.0 kg (p < 0.001). in patients with type 2 diabetes and inadequate glycaemic control on metformin monotherapy, the addition of sitagliptin or glimepiride led to similar improvement in glycaemic control after 30 weeks. Sitagliptin was generally well tolerated. Compared to treatment with glimepiride, treatment with sitagliptin was associated with a lower risk of hypoglycaemia and with weight loss versus weight gain (ClinicalTrials.gov: NCT00701090).

Perspectives and Experiences of Health Care Professionals and Patients with Diabetes regarding Self-Monitoring of Blood Glucose in Canada

Objective: To explore the current perspectives and experiences of Canadian health care professionals and patients with diabetes regarding self-monitoring of blood glucose (SMBG). Design: Qualitative analysis of focus groups in Ottawa, Vancouver and Edmonton. Methods: Seventeen focus groups involving 59 health care professionals (19 pharmacists, 18 certified diabetes educators and 22 physicians) and 40 patients with type 1 or type 2 diabetes were held, using separate moderator's guides. Thematic analysis was used to analyze responses. Results: Health care professionals reported recommending SMBG to most patients with diabetes, regardless of insulin use. They also reported periodically reviewing glucometer results, providing education on interpreting the results and proper use of SMBG devices. The majority of patients with diabetes indicated that they regularly monitored their blood glucose levels and recorded their results. Advantages of SMBG cited by health care professionals included a sense of control over diabetes, the ability to make lifestyle and treatment choices and increased patient confidence. Patients listed expense, discomfort and inconvenience as disadvantages to SMBG. Although patients discussed SMBG readings with their health care professionals, many reported that treating physicians were often uninterested in SMBG results. Physicians tended to refer to SMBG in the context of disease-specific benefits, while certified diabetes educators more often cited the psychological and educational benefits of SMBG. Compared with physicians, pharmacists focused more on the lifestyle and educational benefits of SMBG rather than on changes to medications. Conclusion: SMBG is commonly recommended by health care professionals and regularly performed by most patients with diabetes. Pharmacists and other health care professionals play an important role in educating patients on the appropriate use of SMBG and interpretation of results. To ensure optimal use, pharmacists and other health care providers should review the desired outcomes of SMBG with patients on a regular basis.

Evolution of Data Management Tools for Managing Self-Monitoring of Blood Glucose Results: A Survey of iPhone Applications

Studies have indicated that sharing of self-monitoring of blood glucose (SMBG) data and subsequent feedback from the health care provider (HCP) can help achieve glycemic goals such as a reduction in glycated hemoglobin. Electronic SMBG data management and sharing tools for the PC and smartphones may help in reducing the effort to manage SMBG data. We reviewed software and top-ranking applications (Apps) for the iPhone platform to document the variety of useful features. Additionally, in an attempt to assess metrics such as task analysis and user friendliness of diabetes Apps, we observed and surveyed patients with diabetes as they recorded and relayed sample SMBG results to their hypothetical HCP using three Apps. Observation and survey demonstrated that the WaveSense Diabetes Manager allowed the participants to complete preselected SMBG data entry and relay tasks faster than other Apps. The survey revealed patient behavior patterns that would be useful in future App development. Being able to record, analyze, seamlessly share, and obtain feedback on the SMBG data using an iPhone/iTouch App might potentially benefit patients. Trends in SMBG data management and the possibility of having interoperability of blood glucose monitors and smartphones may open up new avenues of diabetes management for the technologically savvy patient.

The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986

BackgroundThe value and utility of self-monitoring of blood glucose (SMBG) in non-insulin treated T2DM has yet to be clearly determined. Findings from studies in this population have been inconsistent, due mainly to design differences and limitations, including the prescribed frequency and timing of SMBG, role of the patient and physician in responding to SMBG results, inclusion criteria that may contribute to untoward floor effects, subject compliance, and cross-arm contamination. We have designed an SMBG intervention study that attempts to address these issues.Methods/designThe Structured Testing Program (STeP) study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c ≥ 7.5%), non-insulin treated T2DM patients will benefit from a comprehensive, integrated physician/patient intervention using structured SMBG in US primary care practices. Thirty-four practices will be recruited and randomly assigned to an active control group (ACG) that receives enhanced usual care or to an enhanced usual care group plus structured SMBG (STG). A total of 504 patients will be enrolled; eligible patients at each site will be randomly selected using a defined protocol. Anticipated attrition of 20% will yield a sample size of at least 204 per arm, which will provide a 90% power to detect a difference of at least 0.5% in change from baseline in HbA1c values, assuming a common standard deviation of 1.5%. Differences in timing and degree of treatment intensification, cost effectiveness, and changes in patient self-management behaviours, mood, and quality of life (QOL) over time will also be assessed. Analysis of change in HbA1c and other dependent variables over time will be performed using both intent-to-treat and per protocol analyses. Trial results will be available in 2010.DiscussionThe intervention and trial design builds upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates a comprehensive assessment of the intervention. Use of practice site cluster-randomisation reduces the potential for intervention contamination, and inclusion criteria (HbA1c ≥ 7.5%) reduces the possibility of floor effects. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviours.Trial RegistrationCurrent Controlled Trials NCT00674986.

Systematic Review of the Benefits of Self-Monitoring of Blood Glucose on Glycemic Control in Type 2 Diabetes Patients

Background: The benefit of self-monitoring of blood glucose (SMBG) in improving glycemic control in type 2 diabetes has been controversial. This systematic review evaluated the evidence of benefit of SMBG on glycemic control in non–insulin-treated type 2 diabetes. Methods: Clinical trials of SMBG were identified through electronic searches (MEDLINE, EMBASE, and The Cochrane Library) up to and including September 2007. Studies were included if they met the following inclusion criteria: (1) randomized controlled trial comparing SMBG against non-SMBG in type 2 diabetes, (2) included non–insulin-dependent patients only, and (3) hemoglobin A1c (HbA1c) reported as an outcome measure. The efficacy was estimated with the mean difference in the changes of HbA1c from baseline to final assessment between the SMBG and the non-SMBG groups. Results: SMBG was effective in reducing HbA1c in non–insulin-treated type 2 diabetes (pooled mean difference −0.24%; 95% confidence interval [CI] −0.37% to −0.12%; P = 0.0002). HbA1c decreased significantly in the SMBG subgroup where the results of SMBG were used to modify therapeutic regimens (pooled mean difference −0.27%; 95% CI −0.41% to −0.14%; P < 0.0001). In contrast, there was no significant difference in effects between the SMBG subgroup without the use of its results to modify diabetes management and the non-SMBG group (pooled mean difference −0.12%; 95% CI −0.32% to 0.08%). Conclusions: The evidence suggests the beneficial effect of SMBG in improving glycemic control in non–insulin-treated type 2 diabetes as demonstrated by the reduction of HbA1c levels. Specifically, SMBG proved to be useful only when SMBG results were used to adjust therapeutic regimens.