Type 2 Diabetes Phenotype and Progression Is Significantly Different if Diagnosed before versus after 65 Years of Age

Background

The incidence of type 2 diabetes is increasing disproportionately in individuals <65 years of age. It is not known whether disease characteristics in these younger patients are similar to “classic” late-onset type 2 diabetes.

Methods

In the epidemiological cohort study entitled “Retrolective Study: Self-Monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes,” a total of 3268 patients from randomly contacted primary care practices were documented during a mean follow-up period of 6.5 years. All newly diagnosed patients of these practices were included.

Results

At diagnosis, 64.2% of the patients were aged ≤65 years. Thereof, 57.2% were male, whereas in the age group >65 years only 35.0% were male (p < 0.001). The younger group exhibited more severe metabolic deterioration at diagnosis and in the following years than the older group. Conversely, the older group presented at diagnosis with a higher prevalence of cardiovascular risk factors. Self-monitoring of blood glucose (SMBG) was more prominent in the younger group. In both age groups, the use of SMBG was associated with a significantly lower risk (p = 0.003) of a combined end point (severe diabetic complication or all-cause mortality).

Conclusions

There are considerable differences in disease characteristics between people diagnosed with type 2 diabetes during 45–65 years of age versus diagnosis at a later age. Type 2 diabetes diagnosed before the age of 65 years disproportionately affected men and exhibited a more severe disease course, but was characterized by significantly less cardiovascular risk factors in comparison to type 2 diabetes diagnosed at a later age. The use of SMBG was associated with a better clinical outcome in both age groups.     

Cost impact of blood glucose self-monitoring on complications of type 2 diabetes: a Swiss perspective (ROSSO study No.11)

QUESTION UNDER STUDY: despite the increasing prevalence of type 2 diabetes, its financial burden on the Swiss healthcare system remains unclear. Our aim was to determine the cost of self-monitoring of blood glucose (SMBG) in reducing diabetic complications by comparing the direct costs to the Swiss statutory health insurance system of diabetic complications in SMBG users vs. nonusers. METHOD: matched pair analysis of the average annual total cost of diabetes monitoring, treatment-related services, complications and followup in the RetrOlective Study Self-Monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes (ROSSO) study cohort, updated to 2005 from the year of occurrence or diagnosis of diabetes, applying an annual inflation rate of 5%. RESULTS: in those patients treated with oral antidiabetic drugs only, total annual costs were CHF 5,140 in SMBG users and CHF 5,654 in non - users. In those patients treated with oral antidiabetic drugs plus insulin, total annual costs were CHF 8,254 and CHF 11,776, respectively. SMBG accounted for 1.6% to 1.7% of total costs. CONCLUSION: cost analysis indicates that SMBG provides a rapid return on initial investment.     

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

Background

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.

Methods

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.

Results

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.

Conclusion

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.     

Use of a Combined Blood-Glucose- and ?-Ketone-Measuring Device Improves Glycemic Control in Insulin-Treated Patients With Diabetes: The Gold Plus Study

Background:Using self-measurements of blood glucose (SMBG) is daily routine for patients with insulin-treated diabetes, however measuring ß-ketones in blood is not widespread. How the use of a combined device, which can measure both, is accepted in daily routine by patients and will lead to better glycemic control is not well studied.Methods:This multicenter, prospective, noninterventional study assessed the impact of routine use of the GlucoMen® LX Plus on patient acceptance, usage and glycemic control among insulin-treated patients with diabetes mellitus type 1 and type 2. A1c and self-reported frequency of SMBG were evaluated at baseline and also postprandial SMBG, ß-ketone measurements, and use of reminders after 3 and 6 months of use. A total of 631 patients, 254 type 1/350 type 2 (27 no type specified), with mean (SD) baseline A1c 8.5% (1.5), age 54.6 (15.6) years, and 47.3% female were studied.Results:Frequent use of SMBG at baseline led to a higher decrease in A1c at 6 month (V3): –0.3% if SMBG measured up to 1/day versus −0.9% in 4-6/day. Increase of SMBG frequency during the study showed also a negative correlation to A1c, 9.2% at V1 versus 7.6% at V3. Postprandial SMBG was done by 77.7% and ß-ketone measurements by 45.5% of all patients; the reminders were used by 33.4% and led to an increased frequency of SMBG at 6 months.Conclusions:A combined device for SMBG and ß-ketone measurements is well accepted by patients with insulin-treated diabetes and can lead through the avoidance or detection of ketoacidosis/increased frequency of SMBG and increased awareness of the patients to an improved glycemic outcome.     

Consensus guidelines for glycemic monitoring in type 1/type 2 & GDM

Stringent monitoring of blood glucose in diabetes plays an important role as the treatment of the disease itself. Blood glucose monitoring (BGM) strategies such as measurement of Hb1Ac, Self-Monitoring of Blood Glucose (SMBG) and Continuous Glucose Monitoring (CGM) plays a vital role in achieving the important goal of preventing long term complications of diabetes. Although the use of BGM is recommended by various international guidelines in T1DM and T2DM, there is no consensus on the utility of BGM in India. So, there is a need to develop a guidance for uniform monitoring mechanism among the care givers taking into account the variations and challenges that are unique to Indian population. A committee was established that comprised of physicians, researchers and other healthcare professionals having expertise in diabetes treatment to oversee the formulation of guidelines on different monitoring and treatment aspects of diabetes. Extensive literature searches were conducted to identify and analyze the evidence available on BGM. An initial draft of BGM guidelines was presented to core members who discussed the subject matter and presented their opinion. This was then taken to wider expert audience to invite their comments that were incorporated in the initial draft. The first compilation was presented at a conference attended by nearly 200 experts. Again, their opinion was sought and the next version was prepared which was sent to core committee members for the final inputs. The Indian consensus guideline on BGM using Hb1Ac, SMBG and CGM as the primary tools was then finalized.     

Evaluation of the analytical performance of the coulometry-based Optium Omega blood glucose meter

Background

The goal of diabetes treatment is maintaining near normoglycemia based on self-monitoring of blood glucose (SMBG). In this study, an evaluation of the analytical performance of the coulometry-based Optium Omega™ glucose meter designed for SMBG has been carried out.

Methods

The assessment of precision and between-lot variability was based on glucose measurements in ethylene-diaminetetraacetic acid venous blood samples. Glucose concentrations measured in 289 fresh capillary blood samples using the Omega glucose meter and the Biosen C_line analyzer were compared.

Results

Within-run imprecision coefficient of variation for the lower and higher glucose concentrations amounted to 5.09 and 2.1%, respectively. The relative lot-dependent differences found for the lower and higher glucose concentrations were equal to 6.8 and 2.6%, respectively. The glucose meter error calculated for various concentration ranges amounted from 2.22 to 4.48%. The glucose meter error met the accuracy criteria recommended by the International Organization for Standardization and the American Diabetes Association. The Passing-Bablok agreement test and error grid analysis with 96% of results in zone A indicated good concordance of results, including glucose concentrations below 100 mg/dl.

Conclusions

The evaluated Optium Omega glucose meter fits the analytical requirements for its use in blood glucose monitoring in diabetes patients.     

Blood Glucose Pattern Management in Diabetes: Creating Order from Disorder

Background

Self-monitoring of blood glucose (SMBG) is the most accessible way to assess glycemic patterns, and interpretation of these patterns can provide reasons for poor glycemic control and suggest management strategies. Furthermore, diabetes management based on blood glucose (BG) patterns is associated with improved patient outcomes. The aim of this review is therefore to evaluate the impact of pattern management in clinical practice.

Methods

We included a review of available literature, a discussion of obstacles to implementation of SMBG and pattern management, and suggestions on how clinicians and patients might work together to optimize this management feature.

Results

The literature review revealed eight publications specifically describing structured approaches to SMBG and pattern management. Specific information on how SMBG might be structured to detect BG patterns, however, remains limited. Barriers to pattern management include not just practical reasons, but emotional and psychological reasons as well.

Conclusions

Patterns are not always easy to detect or interpret, but on-meter and web-based tools can support both patients and clinicians. Ultimately, successful pattern management requires education and mutual commitment from the clinician and patient—ongoing collaboration is needed to obtain, review, and interpret SMBG values and to make changes based on the patterns.     

Immortal time bias and survival in patients who self-monitor blood glucose in the Retrolective Study: Self-monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes (ROSSO)

Aims/hypothesis  

In the February 2006 issue of Diabetologia, the observational Retrolective Study: Self-monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes (ROSSO) reported a 51% reduction in the risk of all-cause mortality in patients with type 2 diabetes who performed self-monitoring of blood glucose (SMBG). However, these impressive benefits conflict with results from observational studies and randomised controlled trials. We aimed to show that these findings are caused by a flawed design that introduced immortal time bias.     

The Effect of Education and Self-monitoring of Blood Glucose on Glycosylated Hemoglobin in Type I Diabetes

ABSTRACT The influence on glycosylated hemoglobin (HbA₁) of formal education as compared with self-monitoring of blood glucose (SMBG) was studied in a randomized 18-month trial. All adult type I diabetics in a community were identified. Forty-one of these patients had had diabetes for 20 years or less. Thirty-seven patients were included in the study and finally randomized into four groups. Ten patients received individual formal education followed by SMBG, eight patients were instructed in SMBG without pre-education, nine patients were given only formal education and 10 patients made up a reference group. Education did not improve the mean HbA₁ values. SMBG resulted in a decrease by 2% in HbA₁ from 12 to 10% (p<0.05). The final HbA₁ level, however, did not differ significantly between any of the groups. SMBG was accepted by 80% of the patients. The liability to hypoglycemia was about equal in the four groups. It was concluded that SMBG, but not education, improved metabolic control to a certain degree.     

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: A Prerequisite for Diabetes Management in Outcome Trials

Evidence for the value of self-monitoring of blood glucose (SMBG) with regard to the achievement of treatment targets, detection of postprandial glucose excursions, and minimization of glycemic variability is increasing. In large clinical trials, SMBG is a key component for the optimization of diabetes treatment in insulin-treated diabetes. It also plays an essential role in outcome studies. However, details of SMBG use in both the methods and results sections of clinical articles are frequently scarce. Also, a discussion of the SMBG data and its impact on insulin therapy is valuable. In the recently completed Outcome Reduction with an Initial Glargine INtervention (ORIGIN) trial, SMBG was described in detail and insulin titration was largely driven by SMBG. Both aspects largely contributed to the fact that near-normal control was achieved over a long-term period.     

An Analysis of Alternate Site Tests to Improve Patient Compliance with Self-Monitoring of Blood Glucose

Background

Multiple barriers stand in the way of patients performing self-monitoring of blood glucose (SMBG). Alternate-site testing (AST) has been introduced as one solution to reduce pain and improve compliance. In a study published in this issue of Journal of Diabetes Science and Technology, Ito and colleagues studied patients who exclusively used the traditional fingertip blood glucose testing (FBGT) and introduced these patients to the palm blood glucose testing (PBGT). These patients did not see much benefit in using PBGT over FBGT but did plan to use PBGT in the future (likely allowing for increased testing frequency). Future studies should consider populations of patients who may find more benefit to AST—minimizing barriers and improving compliance in diabetes self-management. Additionally, other barriers to SMBG should be explored and solutions studied to improve compliance in diabetes care.     

Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study

Aims/hypothesis The aim of this study was to obtain epidemiological data on self-monitoring of blood glucose (SMBG) in type 2 diabetes and to investigate the relationship of SMBG with disease-related morbidity and mortality. Methods The German multicentre Retrolective Study ‘Self-monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes’ (ROSSO) followed 3,268 patients from diagnosis of type 2 diabetes between 1995 and 1999 until the end of 2003. Endpoints were diabetes-related morbidity (non-fatal myocardial infarction, stroke, foot amputation, blindness or haemodialysis) and all-cause mortality. SMBG was defined as self-measurement of blood glucose for at least 1 year. Results During a mean follow-up period of 6.5 years, 1,479 patients (45.3%) began SMBG prior to an endpoint and an additional 64 patients started SMBG after a non-fatal endpoint. Interestingly, many patients used SMBG while being treated with diet or oral hypoglycaemic drugs (808 of 2,515, 32%). At baseline, the SMBG cohort had higher mean fasting blood glucose levels than the non-SMBG cohort (p<0.001), suggesting that insufficient metabolic control was one reason for initiating SMBG. This was associated with a higher rate of microvascular endpoints. However, the total rate of non-fatal events, micro- and macrovascular, was lower in the SMBG group than in the non-SMBG group (7.2 vs 10.4%, p=0.002). A similar difference was found for the rate of fatal events (2.7 vs 4.6%, p=0.004). Cox regression analysis identified SMBG as an independent predictor of morbidity and mortality, with adjusted hazard ratios of 0.68 (95% CI 0.51–0.91, p=0.009) and 0.49 (95% CI 0.31–0.78, p=0.003), respectively. A better outcome for both endpoints was also observed in the SMBG cohort when only those patients who were not receiving insulin were analysed. Conclusions/interpretation SMBG was associated with decreased diabetes-related morbidity and all-cause mortality in type 2 diabetes, and this association remained in a subgroup of patients who were not receiving insulin therapy. SMBG may be associated with a healthier lifestyle and/or better disease management. Electronic Supplementary Material Supplementary material is available for this article at and accessible for authorised users.     

Consensus Report of the Coalition for Clinical Research��Self-Monitoring of Blood Glucose

The Coalition for Clinical Research—Self-Monitoring of Blood Glucose Scientific Board, a group of nine academic clinicians and scientists from the United States and Europe, convened in San Francisco, California, on June 11–12, 2008, to discuss the appropriate uses of self-monitoring of blood glucose (SMBG) and the measures necessary to accurately assess the potential benefit of this practice in noninsulin-treated type 2 diabetes mellitus (T2DM). Thirteen consultants from the United States, Europe, and Canada from academia, practice, and government also participated and contributed based on their fields of expertise. These experts represent a range of disciplines that include adult endocrinology, pediatric endocrinology, health education, mathematics, statistics, psychology, nutrition, exercise physiology, and nursing. This coalition was organized by Diabetes Technology Management, Inc. Among the participants, there was consensus that:

1. protocols assessing the performance of SMBG in noninsulin treated T2DM must provide the SMBG intervention subjects with blood glucose (BG) goals and instructions on how to respond to BG data in randomized controlled trials (RCTs);
2. intervention subjects in clinical trials of SMBG-driven interventions must aggressively titrate their therapeutic responses or lifestyle changes in response to hyperglycemia;
3. control subjects in clinical trials of SMBG must be isolated from SMBG-driven interventions and not be contaminated by physician experience with study subjects receiving a SMBG intervention;
4. the best endpoints to measure in a clinical trial of SMBG in T2DM include delta Hemoglobin A1c levels, hyperglycemic events, hypoglycemic events, time to titrate noninsulin therapy to a maximum necessary dosage, and quality of life indices;
5. either individual randomization or cluster randomization may be appropriate methods for separating control subjects from SMBG intervention subjects, provided that precautions are taken to avoid bias and that the sample size is adequate;
6. treatment algorithms for assessing SMBG in T2DM may include a dietary, exercise, and/or medication intervention, which are all titratable according to the SMBG values;
7. the medical literature contains very little information about the performance of SMBG in T2DM from RCTs in which treatment algorithms were used for dysglycemic values; and
8. research on the performance of SMBG in T2DM based on sound scientific principles and clinical practices is needed at this time.

     

Consensus report: the current role of self-monitoring of blood glucose in non-insulin-treated type 2 diabetes

The Coalition for Clinical Research--Self-Monitoring of Blood Glucose Scientific Board convened a meeting in San Francisco, CA, July 20-21, 2011, to discuss the current practice of self-monitoring of blood glucose (SMBG) in non-insulin-treated (NIT) type 2 diabetes mellitus (T2DM). Twelve physician panel members from academia, practice, and government attended this meeting. These experts came from the United States, Brazil, Canada, France, Germany, Italy, and the United Kingdom. In addition, three consultants from Australia, Germany, and the United States contributed to the group's final report. This coalition was organized by Diabetes Technology Society. Self-monitoring of blood glucose was studied from eight perspectives related to patients with NIT T2DM: (1) epidemiological studies; (2) randomized controlled trials (RCT)s and meta-analyses; (3) targets, timing, and frequency of SMBG use; (4) incidence and role of SMBG in preventing hypoglycemia with single-drug regimens and combination regimens consisting of antihyperglycemic agents other than secretagogues and insulin; (5) comparison of SMBG with continuous glucose monitoring; (6) technological capabilities and limitations of SMBG; (7) barriers to appropriate use of SMBG; and (8) methods and end points for appropriate future clinical trials. The panel emphasized recent studies, which reflect the current approach for applying this intervention. Among the participants there was consensus that: SMBG is an established practice for patients with NIT T2DM, and to be most effective, it should be performed in a structured format where information obtained from this measurement is used to guide treatment; New, high-quality efficacy data from RCTs have demonstrated efficacy of SMBG in NIT T2DM in trials reported since 2008; Both patients and health care professionals require education on how to respond to the data for SMBG to be effective; and Additional well-defined studies are needed to assess the benefits and costs of SMBG with end points not limited to hemoglobin A1c.     

Effects of a structured self-monitoring of blood glucose method on patient self-management behavior and metabolic outcomes in type 2 diabetes mellitus

Background

The purpose of this study was to evaluate the effect of structured self-monitoring of blood glucose (SMBG) on patient self-management behavior and metabolic outcomes in patients with type 2 diabetes mellitus (T2DM).

Methods

From January to June 2009, 30 patients with basic diabetes education were followed for a period of 90 days. To provide assessment of glycemic control and frequency of dysglycemia, patients, underwent 3 consecutive days of seven-point SMBG during each month for 3 consecutive months, using the ACCU-CHEK 360° View tool. Glucose profiles of the first and third month were used for comparison.

Results

Hemoglobin A1c (HbA1c) improved significantly during the 90-day period in all patients [confidence interval (CI) 95%, 0.32–1.64%, p < .05] and those with poor metabolic control (group B; CI 95%, 0.86–2.64%, p < .05). Mean blood glucose (MBG) values decreased significantly in group B (CI 95%, 0.56–24.78 mg/dl, p < .05) and all cases (CI 95%, 1.61–19.73 mg/dl, p < .05). Meanwhile, there was an average decrease of 15.7 mg/dl in fasting blood sugar (FBS) levels in the whole subjects. Mean postprandial blood glucose levels (MPP) decreased by 19.3 and 11.3 mg/dl in group B and in all cases, respectively. However, there were no significant changes in HbA1c, MBG, FBS, and MPP in people with good metabolic control.

Conclusion

A structured SMBG program improves HbA1c, FBS, MPP, and MBG in people with poorly controlled diabetes. This improvement shows the importance of patient self-management behavior on metabolic outcomes in T2DM.     

Time spent in target range assessed by self-monitoring blood glucose associates with glycated hemoglobin in insulin treated patients with diabetes

Background and aimsSelf-monitoring blood glucose (SMBG) remains a widespread tool to monitor blood glucose. The development of diabetes management systems (DMS) allows SMBG to provide additional information as time spent in target range (TIR). This study evaluates the association between HbA1c and TIR, evaluated through DMS, over 2 months, and 2 weeks.Methods and resultsType 1 (T1D) and Type 2 (T2D) insulin-treated patients with diabetes were enrolled. We used the term PIR (Points in Range) instead of TIR, since SMBG provides point-in-time glucose values rather than a continuous trend over time. PIR was calculated in 2-month and 2-week time ranges before available HbA1c measurement.One-hundred ninety-seven patients with T1D and 36 with T2D were recruited. HbA1c and PIR were inversely associated (2 months: R -0.72, 2 weeks R -0.70; p < 0.0001) in all subjects. The relationship did not change when T1D and T2D patients were analyzed separately. For every 10% change of PIR, there was a change of HbA1c by 0.4%.ConclusionsOur study, for the first time, demonstrates a significant correlation between HbA1c and PIR calculated by DMS. DMS offers additional information useful in disease management of patients with T1D and T2D performing SMBG.     

The Business of Self-Monitoring of Blood Glucose: A Market Profile

The market for self-monitoring of blood glucose (SMBG) approached $8.8 billion worldwide in 2008. Yet despite dramatic double-digit growth in sales of SMBG products since 1980, the business is now facing declining prices and slower dollar growth. Given that SMBG meters and test strips are viewed by consumers and insurers as essentially generic products, it will be extremely challenging for new market entrants to displace well-entrenched existing competitors without a truly innovative technology. Also, in the face of declining glucose test strip prices, market expansion can only occur through identification of more of the undiagnosed diabetes population and convincing existing diabetes patients to adopt glucose testing or to test more frequently. Ultimately, a combination of technology innovations, patient education, and economic incentives may be needed to significantly expand the SMBG market and build sustainable long-term dollar growth for SMBG vendors.