5thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, May 3–5, 2012, Dublin, Ireland

Abstract

Diabetes Technology & TherapeuticsVol. 14, No. 12 Meeting ReportOpen Access5th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, May 3–5, 2012, Dublin, IrelandHilary Hoey, Anita Mlinac, Cam-Tuan Tran, and Christof SchlaegerHilary HoeyDiabetes Ireland, Dublin, Ireland.Faculty of Paediatrics, Royal College of Physicians of Ireland, Dublin, Ireland.Search for more papers by this author, Anita MlinacAdecco Human Resources GmbH, Mannheim, Germany.Search for more papers by this author, Cam-Tuan TranRoche Diagnostics GmbH, Mannheim, Germany.Search for more papers by this author, and Christof SchlaegerRoche Diagnostics GmbH, Mannheim, Germany.Search for more papers by this authorPublished Online:10 Dec 2012https://doi.org/10.1089/dia.2012.0230AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail International experts in the fields of diabetes, diabetes technology, endocrinology, and pediatrics gathered for the 5th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond. The aim of this meeting was to continue setting up a global network of experts in this field and provide an international platform for exchange of ideas to improve life for people with diabetes. In line with previous editions, the 2012 meeting comprised a comprehensive scientific program, parallel interactive workshops, pros and cons debates, and a keynote. All these discussions were intended to help identifying gaps and areas where further scientific work and clinical studies are needed.Opening Lecture: News from the World of DiabetesSatish K. Garg, University of Colorado Denver, Aurora, COIn his opening lecture, Satish Garg focused on some of the perspectives on tomorrow's technologies and how they might shape diabetes care in the upcoming years. Diabetes prevalence is rapidly rising. Although it was expected in 2009 that by the year 2030 there will be 300 million people with the disease, today's expectations estimate more than half a billion people will suffer from diabetes by 2030, accounting for a significant increase in both type 1 (T1D) and type 2 (T2D) diabetes. Accordingly, Garg sees a “need to predict for the next 3–5 years rather than decades.” Most of the increase involves new cases of T2D, which may increase up to 5% per year. Nevertheless, the International Diabetes Federation (IDF) reports there is also a significant increase in T1D. We don't know if this increase is a cause of unrecognized type 1 entity or some changes in the genetics and the autoimmune milieu, Garg stated. Undoubtedly, these increases in prevalence go along with increasing healthcare costs. Ninety percent of today's cost of diabetes care goes toward caring for complications of the disease, not really caring for the disease itself. It should be the goal to spend 90% of the cost in caring for the disease today so that we can save to care for the complications.The Type 1 Diabetes Exchange is an ongoing observational study in the United States that has been sponsored by the Leona Helmsley Trust. The purpose of this network is to improve outcomes for adults and children with T1D by providing a launching point for new clinical research and improving clinical management of the disease. Up to now 25,000 people with T1D have been enrolled. An analysis of the incidence of severe hypoglycemia per 100 patient-years revealed that that severe hypoglycemia has become significantly less frequent in the younger T1D population (up to 25 years) compared with the rates of severe hypoglycemic episodes that were reported 30 years ago in the Diabetes Control and Complications Trial (DCCT) study. However, it appears that we still have a long way to go, in particular when focusing on older patients with T1D who are living much longer nowadays, which implies a relation to hypoglycemia unawareness that is significantly more frequent in the older age groups (≥50 years). It is interesting that the Type 1 Diabetes Exchange did not make any association between overall glycemic control in terms of glycated hemoglobin (HbA1c) values and rate of severe hypoglycemia, which is in contrast to the learning from the DCCT trial.Do these people check their SMBG at home, and does it matter whether they check? Data from 67 leading centers in the United States indicate that the majority of enrolled people with T1D performed three to six SMBG tests per day. Irrespective of the age group or the kind of therapy, a higher SMBG testing frequency was consistently associated with a lower mean HbA1c concentration.Fasting plasma glucose and early treatmentEarly initiation of treatment still appears to be the key to an effective treatment of T2D. Recent data1 from the research group of Matthew Riddle published in Diabetes Care show that if treated early enough, the majority of people with T2D can reach a target HbA1c≤7%. If basal insulin therapy with insulin glargine was initiated in people with T2D and oral antidiabetes therapy at an HbA1c concentration of 8%, 75% of the patients reach the target HbA1c≤7% after 24 weeks. In contrast, if basal insulin initiation is initiated later at HbA1c concentrations of 9.5% or larger, only 34% of the patients reach target HbA1c. Although baseline HbA1c did not affect incidence of severe hypoglycemia, it appears that patient behavior is more relevant in this respect.ORIGIN is a large global trial study investigating whether the provision of sufficient basal insulin to normalize fasting plasma glucose levels may reduce cardiovascular events compared with standard care. The study population of 12,537 people (mean age, 63.5 years) with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or T2D have been randomized to receive insulin glargine (with a target fasting blood glucose [BG] level of ≤95 mg/dL [5.3 mmol/L]) or standard care and to receive ω-3 fatty acids or placebo with the use of a 2×2 factorial design. Garg highlighted that the baseline HbA1c of 6.5% in ORIGIN is remarkable lower than in the last recent cardiovascular outcome trials Action to Control Cardiovascular Risk in Diabetes (ACCORD), Veterans Affairs Diabetes Trial (VADT), and Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation (ADVANCE); however, the baseline rate of macrovascular complications was highest in ORIGIN. This underlines that this trial focuses on early stages of diabetes associated with a high cardiovascular risk. The final results were presented at the 72nd Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia, PA.2Glucose variabilityAre there any new data that support the importance of glycemic variability as a cardiovascular risk factor? Garg recalled a recently published analysis of the A1c Derived Average Glucose (ADAG) study suggesting that mean glycemia and HbA1c show consistent and stronger associations with cardiovascular risk factors than fasting glucose, postprandial glucose levels, or various measures of glucose variability in people with diabetes.3 It is important to note that we have powerful options to reduce glycemic variability. By analysis of data from continuous glucose monitoring (CGM) devices in insulin-treated adolescents with T1D, it could be shown that insulin glargine reduced glycemic variability, measured as the mean amplitude of glycemic excursion (MAGE), significantly better than NPH/lente insulin over a 24-week period. Garg stated that unblinded or real-time (RT)-CGM has the potential to significantly reduce glycemic variability and therefore can be seen as “behavior changers.” Is there a link to oxidative stress markers? The only available data on this topic from Louis Monnier and co-workers4 argue that MAGE may be directly related to markers of oxidative stress, a relationship that is particularly seen in T2D. The ongoing Flat Sugar study in the United States is aiming to further investigate these associations in the short term in T2D.CGMData from the Type 1 Diabetes Exchange network have shown that the percentage of CGM users among these insulin-requiring patients is still low, particularly in the pediatric age group. In fact, there are a lot of supporting data today showing that, irrespective of the age group and how often the devices are used, if they are used more frequently, a beneficial effect on HbA1c is observed: “We are at a crossroads right now, just like we used to be with the SMBG.” According to Garg, CGM provides similar benefits in glucose control for people with T1D using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) therapy. He presented results from a small prospective study he and co-workers did in Denver for which 60 people with diabetes (30 on MDI and 30 on CSII therapy) were instructed to use CGM over a period of 6 months. Without any significant therapy change, the HbA1c decrease at 12 weeks was similar in both groups. Although evidence for CGM use in T2D is still scarce, intermittent use of CGM has been proven to be beneficial over conventional SMBG in a large study performed by Bob Vigersky and co-workers.5Discontinuation of CSII therapy within the first year is a severe challengeThe Type 1 Diabetes Exchange network told us that about 55% of the enrolled population was using an insulin pump. This distribution is most probably not representational of the general U.S. T1D population, in which Garg assumes one out of five people to be an insulin pump user. He expressed his concern that on average one-third of the patients actually reported sending their pumps back to the manufacturer in the very first year after initiating pump therapy.Sensor-augmented pump therapy in T1DThe STAR-3 trial is one of the most prominent trials investigating the use of sensor-augmented pump (SAP) therapy in people with T1D. For this trial, study subjects were randomized into two groups receiving either MDI therapy or SAP. The main outcome of STAR-3 was that over the duration of 1 year and of all age groups analyzed, the SAP group experienced significantly better glycemic control in terms of HbA1c compared with the MDI group.Low glucose suspend (LGS) is a safety feature that has been approved in Europe. Food and Drug Administration (FDA) approval in the United States is still pending. That's why the In-clinic Automation to Simulate Pancreatic Insulin Response (ASPIRE) study was performed, the first and largest trial investigating the safety and efficacy of LGS in the United States. ASPIRE provided proof that the use of LGS is effective in terms of reducing duration and severity of induced hypoglycemia and safe as no significant rebound hyperglycemia was observed, stated Garg, who is the first author of one of the articles that have been published6 on this trial.Nocturnal hypoglycemia remains a significant problem in people with T1D. Several studies have investigated experimental overnight closed-loop systems to address this medical need. Currently available data indicate that these systems can potentially reduce the risk of nocturnal hypoglycemia compared with state-of-the-art open-loop therapy in people with T1D.New basal insulin is awaiting approvalInsulin degludec remains a promising new basal insulin that has been submitted for FDA approval. It is noteworthy that insulin degludec with once-daily dosing provides glycemic control comparable to that with insulin glargine; however, it appears to be consistently associated with less hypoglycemia in people with T2D as well as T1D. In particular, nocturnal hypoglycemia is significantly less frequent with insulin degludec therapy.Garg concluded his talk with the notion that, despite all advanced technologies and therapies available, high rates of suboptimal glycemic control as well as severe hypoglycemia remain the biggest challenge. It is his hope that treatments, in particular the closed-loop system, will help us to reduce the rates of hypoglycemia in the future. Reviewing data from studies like the Type 1 Diabetes Exchange and many other studies, it appears to him that using insulin pumps and CGM effectively lowers HbA1c levels, decreases hypoglycemia, lowers glucose variability, and may be weight neutral, and thus early closed-loop trials that are ongoing are the right path to go, at least regarding people with insulin-requiring diabetes.Demonstrating the Clinical Value—Summary of Important Studies Around Structured TestingMatthias Axel Schweitzer, Roche Diabetes Care, Mannheim, GermanyWhat is the mode of action of BG meters?BG meters obviously do not have a direct mode of action (MoA) but simply provide information on BG concentrations. This glucose information consequently needs to be transferred into a medically meaningful therapy decision and action. Taken together, glucose information and medically meaningful therapy decision and action, it is hoped resulting in improved glycemic control—that is the MoA of BG meters.There is a positive correlation between BG testing frequency and glycemic control. “How do MoA of BG monitoring and correlation between BG testing frequency and glycemic control fit together?” Schweitzer asked the audience. In his view, the element of automation is a key area where manufacturers of medical devices can support the successful use of glucose information and contribute to a more successful disease management. He referred to the example of implementing an automatic bolus advisor in a BG meter that turned out to improve glycemic control in people with diabetes not achieving optimal glycemic control on MDI therapy. The concept of automated bolus calculation was first tested in a “proof-of-concept” study using a separate medical device, not yet embedded in a BG meter or an insulin pump. Later, when the concept was proven to be of value for the patient, the automated bolus calculator was implemented in a BG meter. A large study with more than 200 enrolled people with diabetes, the so-called ABACUS study, is currently ongoing in Germany and the United Kingdom, aiming at analyzing the efficacy and usability of this product. First data from the ABACUS study will be presented at the European Association for the Study of Diabetes (EASD) later this year.To be most effective, SMBG should be performed in a structured formatHaving introduced the concept of automation in terms of bolus calculation, Schweitzer asked how glucose information could be used to manage non–insulin-treated T2D. To provide an answer, Roche Diabetes Care (Mannheim, Germany) has introduced the concept of Structured Testing, which intends to guide people with diabetes and their treating physicians to attain the best glucose information possible by providing the testing algorithm, having the correct analysis of the data from glucose information, the correct diagnosis, and finally support to take the appropriate action. The IDF also recommends a kind of Structured Testing in their 2009 “Guideline on Self-Monitoring of Blood Glucose in Non-Insulin treated T2D.”7 Although the IDF recommends various daily profiles, like testing in pairs, Roche Diabetes Care developed a comprehensive Structured Testing approach with a seven-point BG profile on three consecutive days, the Accu-Chek® 360° View 3-day Profiling Tool. Since 2009, significant numbers of Structured Testing studies have been performed, for example, the STeP Study in the United States and the PRISMA Study in Italy. Although the testing algorithms used differ in terms of the BG measurements taken per day, the principle of structured rather than random testing is what they all have in common. As a consequence, all these studies reported significantly improved diabetes outcomes and improved care of patients.SMBG is an established practice for patients with T2D and to be most effective, it should be performed in a structured format. That is the conclusion of a recent review on the current role of SMBG in non–insulin-treated T2D published8 in the Journal of Diabetes Science and Technology last year. Talking about MoA, it is important that we are able to explain the observed added medical value of Structured Testing. The Structured Testing Protocol (STeP) Study proved that people in the Structured Testing arm of the study had significantly more medication or lifestyle changes at any clinical visit. Consequently, more people in the Structured Testing arm started a therapy with insulin compared with the control arm. A very similar picture can be drawn from the Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients (PRISMA) Study.Schweitzer closed his talk by concluding that regarding the role of SMBG in current diabetes management, today there is substantial evidence to support that • the MoA of SMBG is well understood and is to transfer glucose information into a medically meaningful therapy decision and action.• SMBG is mandatory to achieve and maintain good glycemic control.• SMBG testing frequency is positively associated with improvement in glycemic control.• Structured Testing provides added medical value compared with random BG testing without increasing the frequency of testing.• Structured Testing makes SMBG cost efficient.• Different Structured Testing algorithms can be applied according to local medical practices and individual patient preferences.• Structured Testing can be applied to all people with diabetes, T1D and T2D, non–insulin- as well as insulin-treated.How Would You Decide? Results of the DECIDE Study and Interactive Case StudiesHelena Wachslicht Rodbard, Endocrine and Metabolic Consultants, Rockville, MD Oliver Schnell, Diabetes Research Institute of the Diabetes Research Group, Helmholtz Center Munich, Munich, GermanyIn this interactive session, Helena Rodbard and Oliver Schnell presented the results of the DECIDE study as well as a selection of case examples. Attendants of the meeting had the opportunity to interact via a TED system at certain points of the presentation.“Collecting data can be very frustrating from a patient's point of view, especially if the physician or clinician does not act upon the numbers. Obviously as it becomes frustrating, patients give up monitoring the blood glucose levels, and eventually their control deteriorates and that all contributes to inertia,” Rodbard described one of the key obstacles for patients to stay compliant with common SMBG recommendations. However, there are ways to change this paradigm and empower patients as well as their physicians to use SMBG appropriately and consistently.Clinical inertia or “treat to failure” is very common among cliniciansToday, mixed data regarding the benefits of SMBG exist from a variety of studies. Although some studies have shown SMBG to be an important component of diabetes management, others showed little or no benefit. According to Rodbard, this is not much of a surprise—when people with diabetes and their treating physicians do not act or are not able to act upon BG information, it's not going to be of any benefit. More recent studies have shown benefits in glycemic control, improving and changing health behaviors, and more timely and persistent treatment intensification. The STeP Study was one of these studies. Beneficial effects on glycemic control were achieved just by a simple paper tool: monitoring BG levels on three consecutive days. At the end of a year, there was a 0.5% reduction in HbA1c in favor of the Structured Testing algorithm, as a result of treatment intensification. It happened very early, even in the first month, Rodbard explained.The purpose of the virtual, online DECIDE study was to evaluate the impact of an automated decision support tool (DST) on clinicians' ability to identify glycemic abnormalities in structured SMBG data and make the appropriate therapeutic changes based on the glycemic patterns observed. Therefore, 288 U.S. healthcare professionals (HCPs) (approximately 40% primary care physicians, 40% family practitioners, and about 20% nurse practitioners and/or physician's assistants) were equally randomized into four groups receiving either • structured BG monitoring data from the Accu-Chek 360° View paper tool (Structured Testing Group [STG])• structured bG data from the 360° View paper tool together with printed reports from the DST (DST group)• structured BG data from the 360° View paper tool together with the an educational DVD how to interpret the structured BG data (DVD group)• structured BG data from the 360° View paper tool together with a combination of DST reports and educational DVD (DST+DVD group).The cases depicted different BG patterns, fasting hyperglycemia, preprandial hyperglycemia, bedtime hyperglycemia, hypoglycemia, postprandial excursions, and normoglycemia. HCPs were asked to identify the primary glycemic abnormality and choose an appropriate therapy based on presented BG information. Responses were compared with the correct answers, which derived from an endocrinologist expert panel.Overall, 51% of HCPs who used data only from the 360° View paper tool identified the primary glycemic abnormality correctly, whereas for use of DST, DVD, and DST+DVD, the percentage increased to 77%, 72%, and 82% of the HCPs, respectively. So, what percentage of the clinicians identified the primary glycemic abnormality and selected the appropriate therapy correctly? Significantly more HCPs in the DST, DVD, and DST+DVD groups (49%, 51%, and 55%, respectively) did versus HCPs in the STG (33%).The positive aspect about this intervention is that it did not afford much time, stated Rodbard: “We all know how pressed clinicians are when seeing their patients, and fortunately we can see here with all of that, the average case only took about 2–2.5 minutes for analysis and recommendation of appropriate action.”She concluded that the clinicians enrolled in the DECIDE study did relatively well when using the structured SMBG form alone. However, use of DVD training, a DST, or both substantially improved clinician performance. And, both the DVD training program and DST provide time-efficient approaches to diabetes management and can potentially play an important role in providing education and clinical support. “It would be very important to do a real-life study with real patients, showing that diabetes management actually improves and that hopefully also the complications of diabetes can be reduced.”Subsequently, Oliver Schnell presented three case examples from the DECIDE study. Participants of the symposium were asked to identify the primary glycemic abnormalities and the treatment of choice from preselected answers via a TED voting system.Adherence and Nonadherence to Structured Testing: Implications for Intervention from the STeP StudyLawrence Fisher, Department of Family and Community Medicine, University of California, San Francisco, San Francisco, CAHow do we bring the data from the STeP Study into the real world of clinical care?That was the question Lawrence Fisher raised, and he anticipated that the findings from the STeP Study may lead to some hypotheses about what we can do to translate at least some of the data into what we do on a day-to-day basis. In his view, it is worth to have a closer look at adherence to the testing protocol for the subjects in the STG. STG adherence qualifying for the per protocol (PP) analysis of the STeP Study was defined by the requirements to bring in the filled Accu-Chek 360° View paper tool at four of five visits and having completed at least 80% of requested tests at each visit. Because of this strict criterion, only 51% of all STG patients were included in PP analyses (STG/A), whereas 49% did not follow protocol (STG/NA). Although these patients tested, they did not do so at a rate that conformed to the study criterion. Of the STG/NA patients, 17% dropped out before 12 months, and 32% did not follow the STG protocol. According to PP analysis, the STG/A patients experienced a 0.5% improvement in HbA1c versus patients in the active control group (ACG). STG/NA patients, in fact, showed no improvement versus ACG patients at the end of the study.For him, the key factor that made the STeP Study work was that poorly controlled, obese people with T2D suddenly and surprisingly began and continued to test their BG. Given the fact that all subjects randomized to the STG received the same training but not all of them tested over the duration of the study as required, Fisher hypothesized that comparing these two groups at baseline might provide some clues about what made the STeP Study work or not work for these patients.Substantive differences between STG/A and STG/NA patients at baseline and during the course of studyWhen comparing STG/A and STG/NA patients, Fisher and co-workers identified significant baseline differences. The STG/NA patient group comprised significantly more minorities, showed significantly lower diabetes self-efficacy (SE), had significantly more co-morbidities, and marginally lower “autonomy motivation” (AM) versus STG/A patients. It is remarkable that both STG/A and STG/NA had relatively similar patterns in change in HbA1c, diabetes distress, SE, and AM over the first 3 months of the study. At Month 3, however, the STG/NA group diverged from the STG/A group and demonstrated poorer scores on HbA1c, SE, diabetes distress, and AM. Over the remaining months of the study, their performance on these measures decreased further, and by 12 months, their scores on these measures met the level of control patients (ACG).STG/A patients enter a positive motivational hypothesisFisher proposed that a mutually reinforcing, reciprocal sequence of behavioral, biological, and psychological change over time enabled STG/A patients to sustain ongoing SMBG behavior. In their case, initial SMBG behavior leads to improvement of control parameters, like HbA1c, and to improved psychology changes in distress, SE, and AM. In contrast, STG/NA patients, who entered the study with poorer initial skills, enter a negative, de-motivational process. At first, there is a positive process, but it is not sustained. These people begin with low motivation and need help at the outset to sustain the SMBG sequence over time (behavior, biology, psychology).“What do we know about improving engagement that will help patients shift from an initial de-motivational to a positive motivational experience to help initiate and sustain SMBG behavior over time?” Fisher asked. According to him, it is most important to keep in mind that motivation for disease management behavior is driven primarily by feelings, beliefs, and expectations. He appeals for striving to bring covert feelings, beliefs, and expectations that drive SMBG behavior into an overt conversation in a structured way.The AASAP model targets de-motivational feeling, beliefs, and expectationsFisher introduced his newly developed five-step program for intervention—the Anticipate, Acknowledge, Standardize, Accept, and Plan (AASAP) program.9 This brief, highly structured, and evidenced-based model is derived from motivational interviewing and social exchange theory and targets the de-motivational feelings, beliefs, and expectations that derail SMBG behavior, aiming to label, acknowledge, and normalize them.“Adherent patients tested because of a positive, engaged, motivational experience, which I suggest is an integrated sequence of behavior, biology and psychology,” Fisher wound up his talk. One result of the study was that SMBG training alone does not assure effective SMBG and Accu-Chek 360° View paper tool use for STG/NA patients—and these make up about 50% of the sample. Therefore, Structured Testing training is necessary but not sufficient for 50% of non–insulin-using adults with T2D. A “comprehensive” Structured Testing program needs to include the SMBG behavioral component (e.g., Accu-Chek 360° View paper tool) and the SMBG engagement/motivational component (i.e., beliefs, feelings, and expectations about SMBG in a structured conversation).The presentation of Larry Fisher was followed by an interactive discussion with the audience—What can we do to identify patients that are initially motivated to adhere, and how can we commit the remaining ones?—led by Fisher and Frank Snoek.Are the New Social Media (Facebook, Twitter, etc.) the Key to a More Efficient and Effective Diabetes Education?Jill Weissberg-Benchell, Children's Memorial Hospital, Chicago, ILJill Weissberg-Benchell opened the session by talking about the role of new social media in diabetes education. The presentation focused on what social media have to offer and concluded with possible concerns that might be raised with them: There are more people using Facebook today than the number of people that lived on this entire planet 200 years ago. As of September 2009, 93% of teens in the US and 74% of adults were online. 73% of wired teenagers in the U.S. use social networking sites, which is up from 55% just three years before. 72% of young adults (aged 18–29) use social networking sites, as do 47% of wired adults. In the year 2011, the average monthly traffic of unique visitors to top websites and social networking sites exceeded 2 billion.10Weissberg-Benchell described the current progress of information technology that provides the basis for the opportunity to implement such tools into diabetes education as well. Given this progress, social networking allows people with diabetes to interact and share their experiences and concerns among themselves.What can social media and social networking offer?Weissberg-Benchell outlined different positive aspects about social media and their impact on diabetes education: • Knowledge. Social networking sites, to a high degree, are used to gain information on and learn more about diabetes and its treatment. People with diabe