Self-monitoring Of Blood Glucose Regimen Research Articles

Systematic Review of Self-Monitoring of Blood Glucose in Patients With Type 2 Diabetes.

The benefit of self-monitoring of blood glucose in reducing HbA1c in non-insulin-treated participants remains unclear. HbA1c may be improved in this population with said self-monitoring. The aim of this study was to conduct meta-analyses of glycemic control in non-insulin-treated participants with Type 2 diabetes: self-monitoring of blood glucose versus usual care, structured versus unstructured self-monitoring of blood glucose, and use of self-monitoring of blood glucose readings by clinicians to adjust (or modify) therapy versus usual care. MEDLINE, Embase, and Cochrane Central were electronically searched to identify articles published from January 1, 2000, to June 30, 2020. Trials investigating changes in HbA1c were selected. Screening was performed independently by two investigators. Two investigators extracted HbA1c at baseline and follow-up for each trial. Nineteen trials involving 4,965 participants were included. Overall, self-monitoring of blood glucose reduced HbA1c. Preplanned subgroup analysis showed that using self-monitoring of blood glucose readings to adjust therapy contributed significantly to the reduction. No significant improvement in HbA1c was shown in self-monitoring of blood glucose without therapy adjustment. The same difference was observed in structured versus unstructured self-monitoring of blood glucose. HbA1c is improved with clinician therapy modification based on structured self-monitoring of blood glucose readings. Implications are for clinicians to prescribe structured self-monitoring of blood glucose to modify therapy based on the readings and not prescribe unstructured self-monitoring of blood glucose. Participants with suboptimal glycemic control may benefit most. A self-monitoring of blood glucose regimen that improves clinical and cost-effectiveness is presented. Future studies can investigate this regimen specifically.

Clinical Evaluation of a New, Lower Pain, One Touch Lancing Device for People With Diabetes: Virtually Pain-Free Testing and Improved Comfort Compared to Current Lancing Systems.

Patients worldwide use lancing devices to perform self-monitoring of blood glucose (SMBG). Continued innovation remains important to minimize pain associated with finger sticking to facilitate patient adherence to SMBG regimens. The original One Touch Delica lancer (OTD) reduced the pain of testing. This study investigated a completely re-engineered lancing system, called One Touch Delica Plus (OTDP), intended to further minimize pain while improving the patient experience. One hundred and three subjects (type 1 or 2 diabetes) experienced finger sticks with both lancing systems. Device depth and blood volume (BV) generation were determined during visit 1. These parameters were used during pain assessments in visit 2. Patient feedback was also recorded using surveys. Finger-stick testing was less painful using OTDP compared to original OTD irrespective of whether 30 (-48.2 mm, -30.4 mm, P < 0.0001) or 33 gauge (-42.6 mm, 30.5 mm, P = 0.0004) lancets were used. All 103 subjects generated the required BV (≥0.4 µL) per protocol. At equivalent depth penetration, OTDP generated higher average BVs than OTD using 30 (1.58 µL, 1.10 µL) or 33 gauge lancets (1.39 µL, 0.98 µL). Subjects responded that testing with OTDP was virtually pain free (78%) and that testing with OTDP was less painful than using their current lancing systems (79%) or original OTD (67%). OTDP demonstrated lower pain than the original OTD lancing system and participants agreed that testing with OTDP was virtually pain free and less painful than using their current lancing systems.

Effects of Structured Versus Unstructured Self-Monitoring of Blood Glucose on Glucose Control in Patients With Non-insulin-treated Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.

The use of self-monitoring of blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes is debated. Meta-analyses of randomized clinical trials (RCTs) suggest a small reduction of HbA1c in patients using SMBG, without considering potential confounders, such as SMBG regimen and use of SMBG data to adjust diabetes medications. A meta-analysis was performed including RCTs in patients with non-insulin-treated type 2 diabetes, with an intervention of ≥24 weeks and HbA1c as the primary endpoint, to verify the effect of SMBG (vs no monitoring), structured SMBG (vs unstructured), and of SMBG-driven therapy adjustments. In RCTs (n = 8) comparing SMBG with no SMBG (1277 and 1072 patients, respectively), SMBG reduced HbA1c by -0.17% (95% CI -0.25 to -0.09%, P < .003). The reduction in HbA1c was greater in RCTs (n = 3) in which SMBG data were used to adjust diabetes medications (HbA1c decrease: -0.3% [95% CI -0.49 to -0.1%]) than in RCTs (n = 6) where SMBG data were not used for this purpose (HbA1c decrease: -0.1% [95% CI -0.2 to 0.0%]) ( P < .005). In the RCTs comparing structured and unstructured SMBG (757 and 750 patients, respectively), in which structured SMBG data were also used to adjust diabetes medications, the HbA1c difference between groups at study end was -0.27% (95% CI -0.49 to -0.04%, P < .018). In RCTs performed in non-insulin-treated patients with type 2 diabetes, SMBG is associated with a significant, although small, reduction in HbA1c. HbA1c reduction was greater with structured SMBG and when structured SMBG data were used to adjust diabetes therapy.

Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol

BackgroundFor the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting.Methods/DesignUsing stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control.DiscussionThis pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed.Trial registrationClinicalTrials.gov NCT02033499, January 9, 2014.

Diabetes technology and the human factor.

The impressive progress achieved in recent years in diabetes technologies has made diabetes technological devices such as continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) a significant part of diabetes treatment. Many studies conducted in recent years emphasized the advantages of using these technologies. The concept of the “human factor” in diabetes technologies as discussed in this chapter has several different aspects. First, it can refer to the way patients are satisfied with the use of the device and whether it is perceived convenient or inconvenient. For example, is the device perceived as “user friendly” (easy to learn and to operate, comfortable, does not cause many hassles). Second, there is the issue of effectiveness of the technology as it relates to their day-to-day diabetes management. For example, there is an improvement in glycemic control when one diabetes treatment regimen is compared to another (i.e., CSII vs. multiple daily injections (MDI)). Those two fundamental aspects may have different meanings for different groups. For example, different age groups (toddlers, children, adolescents, young adults, adults, and older people) can see different advantages and disadvantages in technological devices. The feasibility and utility of technological devices also need to fit the environments in which they will be used, such as school, the work place, and/or home. Specific subgroups such as diabetic youth with eating disorders can have unique interactions with diabetes technologies. In addition, diabetes technologies can be used as a measurement device, providing more rich and accurate data about patients' self-care that can contribute to our understanding of concepts such as adherence and satisfaction, and they can provide measurement tools to assess how glycemic control can effect cognition and intelligence. The present chapter will review articles published in the last year that have studied some of these issues.

Challenging evidence and assumptions: is there a role for self-monitoring of blood glucose in people with type 2 diabetes not using insulin?

Background:There is debate in the literature about the effectiveness of self-monitoring of blood glucose (SMBG) for people with type 2 diabetes (T2DM) who do not use insulin. Several recent systematic reviews and meta-analyses conclude that SMBG does not have any clinical benefit for this group.Objective:We critically appraise the available evidence, and argue whether SMBG is warranted for people with non-insulin-treated T2DM.Results:Considerable heterogeneity exists amongst the literature, and aspects of the methodology of some of these studies confound interpretation of results. Recent evidence demonstrates that when SMBG is ‘structured’, incorporated as part of a complex intervention, and embedded within education and collaborative care, improvements in average blood glucose levels result. In contrast, studies that do not apply SMBG systematically, or that assess a low frequency SMBG regimen that precludes identification and interpretation of SMBG patterns, are not clinically effective. Psychosocial outcomes, such as self-efficacy and diabetes-related distress, and other clinical outcomes, such as hypoglycaemia detection, should also be considered as important clinical endpoints.Limitations:This is not a systematic literature review. The literature is limited by a lack of studies evaluating a ‘structured’ approach to SMBG.Conclusions:It is the quality, not quantity, of SMBG that makes a difference to outcomes for people with non-insulin-treated T2DM. The benefits of ‘structured’ SMBG should be considered as part of a complex intervention when making decisions about policy and practice, and assumptions about the benefits of SMBG for people with non-insulin-treated T2DM should be challenged.

Addressing self-monitoring of blood glucose: Advocating paired glycemic testing for people with type 2 diabetes.

Addressing self-monitoring of blood glucose: Advocating paired glycemic testing for people with type 2 diabetes.

Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention

Self-monitoring of blood glucose (SMBG) is a core component of diabetes management. However, the International Diabetes Federation recommends that SMBG be performed in a structured manner and that the data are accurately interpreted and used to take appropriate therapeutic actions. We designed a study to evaluate the impact of structured SMBG on glycemic control in non-insulin-treated type 2 diabetes (T2DM) patients. The Prospective, Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) is a 12-month, prospective, multicenter, open, parallel group, randomized, and controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients treated with oral agents and/or diet. One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy. Eligible patients will be randomized to the intensive structured monitoring (ISM) group or the active control (AC) group, with a glycosylated hemoglobin (HbA1c) target of <7.0%. Intervention will comprise (1) structured SMBG (4-point daily glucose profiles on 3 days per week [ISM]; discretionary, unstructured SMBG [AC]); (2) comprehensive patient education (both groups); and (3) clinician’s adjustment of diabetes medications using an algorithm targeting SMBG levels, HbA1c and hypoglycemia (ISM) or HbA1c and hypoglycemia (AC). The intervention and trial design build 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 assessment of the intervention. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors. ClinicalTrials.gov (NCT00643474).

Lancing: Quo Vadis?

Today, lancing fingertips or alternative sites for obtaining a blood sample for self-monitoring of blood glucose (SMBG) is a standard procedure for most patients with diabetes. The need for frequent lancing and associated discomfort and pain can be seen as a key hurdle for patients to comply with SMBG regimens. This article provides an overview of the status quo and future of lancing, focusing on key areas for future developments driven by customer and market needs. We also review technical issues and provide a background for possible improvements. The act of puncturing the skin with a lancet to obtain a blood sample seems to remain the standard procedure for the foreseeable future, because alternate ways of providing a blood sample have not demonstrated overall superiority (e.g., with laser technology). Other methods, which avoid lancing entirely, have also not gained broad market acceptance (e.g., minimally invasive continuous glucose monitoring) or not shown technical viability (e.g., noninvasive glucose monitoring). In relation to blood glucose (BG) meters and test strips, lancing has been a "stepchild" with regards to commercial attention and development efforts. Nevertheless, significant technological improvements have been made in this field to address key customer needs, including better performance (regarding pain, wound healing, and long-term sensitivity), reduced cost, and higher integration with other components of BG monitoring (e.g., integration of the lancing device with the glucose monitor). From a technical perspective, it is apparent that highly comfortable lancing can be accomplished; however, this still requires fairly advanced and complex devices. New developments are necessary to achieve this level of sophistication and performance with less intricate and costly system designs. Manufacturers' motivation to pursue these developments is compromised by the fact that they might not recoup their development cost on commercial advanced lancing systems through direct profits, but only through its positive influence on adherence and increased more profitable sensor utilization. We believe that two main driving forces will continue to push the evolution of lancing and sampling technology: (1) the need for maximum lancing comfort and (2) the advent of fully integrated systems, realizing a device in which all steps for SMBG are incorporated, thus providing a "one-step" experience. Rendering lancing a "nonissue" will eliminate a key barrier to adherence with appropriate SMBG regimens. Providing sophisticated lancing devices that allow the highest level of comfort and/or seamless blood sampling is key to improving user acceptance. This may have a greater impact on metabolic control than many of the new and expensive antidiabetic drugs.

Recognition, Prevention, and Proactive Management of Hypoglycemia in Patients with Type 1 Diabetes Mellitus

Hypoglycemia is the key barrier that prevents patients from optimizing glycemic control with the use of pharmacotherapeutic interventions. Optimal glycemic control for patients with type 1 diabetes (T1DM) includes methods that provide glucose-regulated physiologic insulin replacement or secretion in association with glucose monitoring methods designed to predict and prevent acute extreme changes in glycemic variability. Patients with T1DM experience an average of 2 episodes of symptomatic hypoglycemia each week and at least 1 episode of severe, disabling hypoglycemia annually. Asymptomatic hypoglycemia is common, as shown in studies using continuous glucose monitoring (CGM). Episodes of hypoglycemia (symptomatic and asymptomatic) impair counterregulatory defenses against subsequent events, resulting in the inability to respond to and recover from serious hypoglycemia. This defective counterregulation is known as hypoglycemic-associated autonomic failure. When patients are prescribed a more intensive medication regimen or reinforcing lifestyle interventions, such as medical nutrition therapy and exercise therapy, providers should also assess their ability to proactively identify and manage hypoglycemia. Although self-monitoring of blood glucose regimens, such as pre- and post-meal and periodic middle-of-the-night glucose testing, can help predict the risk of developing hypoglycemia, CGM technology allows patients to receive real-time notification of impending events either through preset alarms or simply by looking at the device display. This review explores the utility of initiating CGM within the primary care setting for patients at high risk for developing hypoglycemia.

Self-measurement of blood glucose. Accuracy of self-reported data and adherence to recommended regimen.

Reflectance meters containing memory chips were used in a study that addressed several questions concerning routine use of self-monitoring of blood glucose (SMBG), including accuracy of patient blood glucose (BG) diaries, reliability of self-reported frequency of SMBG, and adherence to recommended SMBG regimen. Thirty adults with insulin-dependent diabetes used memory meters and recorded test results in diaries for 2 wk while performing their normal SMBG regimen. Analysis of glucose diaries showed that only 23% of the subjects had no diary errors and 47% had clinically accurate diaries (less than 10% error rate). The most common types of errors were omissions of values contained in meter memory and additions of values not contained in meter memory, with significantly more omissions than additions. Alterations of test values (e.g., changing a 300-mg/dl reading to 200 mg/dl) were extremely rare. There was no difference in the rate of errors that resulted in a more positive clinical profile (omitting unacceptable values and adding acceptable values) or a more negative clinical profile (omitting acceptable values and adding unacceptable values). Examination of the actual frequency of SMBG showed that most subjects (56.6%) measured their BG an average of two to three times each day. Self-report of SMBG frequency correlated with both actual frequency and HbA1. Although actual frequency of SMBG was not related to physicians' recommendations, the majority (64%) of subjects were self-testing as often or more often than they had been instructed.