Digital Diabetes Congress 2019.

New applications of digital health software and sensors for diabetes are rapidly becoming available. The link between healthcare, wearable or carryable devices, and the use of smartphones is increasingly being used by patients for timely information and by healthcare professionals to deliver information and personalized advice and to encourage healthy behavior. To assemble stakeholders from academia, industry, and government, Diabetes Technology Society and Sansum Diabetes Research Institute hosted the 3rd Annual Digital Diabetes Congress on May 14-15, 2019 in San Francisco. Physicians, entrepreneurs, attorneys, psychologists, and other leaders in the diabetes technology field came together to discuss current and future trends and applications of digital tools in diabetes. The meeting focused on eight topics: 1) User Interface/User Experience (UI/UX) for Digital Health, 2) clinical aspects, 3) marketing, 4) investment, 5) regulation, 6) who owns the data, 7) engagement, and 8) the future of digital health. This meeting report contains summaries of the meeting's eight plenary sessions and eight panel discussions, which were all focused on an important aspect of the development, use, and regulation of diabetes digital tools.

Digital Diabetes Congress 2018.

Digital health is capturing the attention of the healthcare community. This paradigm whereby healthcare meets the internet uses sensors that communicate wirelessly along with software residing on smartphones to deliver data, information, treatment recommendations, and in some cases control over an effector device. As artificial intelligence becomes more widely used, this approach to creating individualized treatment plans will increase the opportunities for patients, even if they are in remote settings, to communicate with and learn from healthcare professionals. Simple design is needed to promote use of these tools, especially for the purpose of increased adherence to treatment. Widespread adoption by the healthcare industry will require better outcomes data, which will most likely be in the form of safety and effectiveness results from robust randomized controlled trials, as well as evidence of privacy and security. Such data will be needed to convince investors to direct resources into and regulators to clear new digital health tools. Diabetes Technology Society and William Sansum Diabetes Center launched the Digital Diabetes Congress in 2017 because of great interest in determining the potential benefits, metrics of success, and appropriate components of mobile applications for diabetes. The second annual meeting in this series took place on May 22-23, 2018 in San Francisco. This report contains summaries of the meeting's 4 plenary lectures and 10 sessions. This meeting report presents a summary of how 55 panelists, speakers, and moderators, who are leaders in healthcare technology, see the current and future landscape of digital health tools applied to diabetes.

Impact of dementia on costs of modifiable comorbid conditions.

OBJECTIVES: To use the CMS 5% data sample to explore the impact of Alzheimer disease and other dementias (ADOD) on individual and population costs of certain potentially modifiable comorbid conditions, in order to assist in the design of population health management (PHM) programs for individuals with ADOD. STUDY DESIGN: A cross-sectional retrospective analysis was performed on parts A and B claims data of 1,056,741 Medicare beneficiaries 65 years and older with service dates in 2010. METHODS: The primary analysis compared the prevalence and costs of 15 comorbid conditions among those with and without ADOD in the entire sample of 1,056,741; in addition, a subset of beneficiaries without ADOD were matched by age, sex, and race on a 1:1 basis to beneficiaries with ADOD. Prevalence and cost ratios were calculated to examine the impact of potentially modifiable study comorbid conditions in both populations. RESULTS: The prevalence of ADOD in the entire sample was 9.4%, and their costs represented 22.8% of the total. In the matched sample, all 15 comorbid conditions chosen for the study were more prevalent and showed higher mean individual costs in beneficiaries with ADOD compared with those without. The ADOD population also had higher costs and prevalence than the non-ADOD population when single comorbid conditions were examined separately. Study conditions with the highest individual cost ratios were urinary tract infections (UTIs), diabetes with complications, and fractures. Study conditions with the highest population cost ratios were fractures, UTIs, and diabetes without complications. CONCLUSIONS: Prevalence and costs of all study comorbidities were higher in beneficiaries with ADOD compared with those without. Individual cost ratios and population cost ratios may be useful for PHM programs trying to cost-effectively manage individuals with ADOD and comorbid chronic conditions.

Digital Diabetes Congress 2017.

The purpose of developing mobile applications for diabetes is generally to: (1) provide enhanced access to timely information for patients, health care professionals, and researchers; (2) facilitate remote monitoring and diagnosis of patients, often based on information delivered by wearable devices; (3) provide decision support to assist patients in selecting treatment; or (4) deliver timely recommendations for treatment to increase adherence to prescribed therapy. There is a perception that mobile applications can provide meaningful clinical benefits, however, there is only sparse convincing evidence to support this belief at the present time. Compounding this problem is the short life span of digital software, such that if a traditional type of randomized controlled trial is conducted on a product, by the time the study has been designed, approved by an IRB, conducted, and analyzed, the product might have significantly changed to a next generation system. Because of great interest in establishing what are the potential benefits, metrics of success, and appropriate components of mobile applications for diabetes, Diabetes Technology Society and William Sansum Diabetes Center launched the Digital Diabetes Congress, March 7-8, 2017, in San Francisco. This report contains summaries of the meeting's 12 sessions. Each summary was written by the session's moderator who helped develop the session prior to the event and keep it on track during the event. This meeting report presents a summary of how 57 panelists, speakers, and moderators, who are leaders in digital health, see the current and future landscape of digital health tools applied to diabetes.

Digital health tools for diabetes.

Digital health tools are providing patients with easier ways to keep track of their blood glucose levels and other key self-reported data, such as carbohydrates ingested, medication administered, and physical activity. Data are often uploaded into the cloud where physicians and other members of the care team can access them. Clinical studies are beginning to demonstrate efficacy of some of these tools, and Food and Drug Administration approval, when present, provides some much-needed validation. It is anticipated that these tools will continue to evolve and patient acceptance will continue to grow. Physician and care teams will need to familiarize themselves with the tools their patients are using and provide guidance and support for their use.

A beginner's guide to digital health for ambulatory care clinicians.

Digital health technology is already playing a larger role in how healthcare consumers receive information about health concerns and how patients manage wellness and disease. The influence of mobile apps, wireless medical devices and other tools for patient monitoring will soon be felt in almost every physician practice. In an environment where regulatory standards are still in flux, some of these technologies are validated and reliable, others are not. We present the first in a series of systematic guidelines to assist physicians in navigating digital health technologies that they will encounter in the office setting.

An epidemiologic perspective on a case management program.

PURPOSE: to improve a case management (CM) program using the principles and tools of epidemiology. Specifically, to use epidemiology to describe the population being managed, to analyze factors influencing outcomes, to assess the degree to which the CM process (or intervention) is related to those outcomes, to utilize the findings in order to make recommendations (to take action) for both better evaluation and improved and more efficient CM process, to provide an estimate of the impact of the CM program based on the comparison of pre-CM and post-CM interventions, and finally to discuss the caveat that pre-CM period probably does not provide a prediction of patterns to be expected in the post-CM period had CM not been present (an ideal, but difficult-to-find referent population for this kind of effectiveness analysis). PRIMARY PRACTICE SETTING(S): a Medicare Advantage health plan. FINDINGS: there were a total of 12,185 individuals who met the continuous enrollment requirement of 6 months (28 days) prior to initial contact with the CM department and 6 months after the contact date: 53% were female; the average age was 73.9 (standard deviation = ± 9.5). There was a linear relationship between the average "dose" of CM-as measured by the number of times a case manager had contact with a case-and the risk profile of the case-as measured by a standard risk assessment tool provided by the Centers for Medicare & Medicaid Services. The month-to-month costs for the study population prior to CM showed a sharp rise in the month prior to the initial contact with CM and a sharp decline beginning before the contact. This pattern was consistent across different risk profiles and our operational definition of CM "dose."The average costs 6 months prior to CM were higher than the average costs 6 months after the CM. The difference in cost varied by "dose" category. When coupled with the number of cases per dosage category, the greatest value for the CM program was in the management of moderate risk cases called two to four times.However, some of the overall decline that begins prior to the initial CM contact is likely attributed to "regression to the mean" (i.e., costs may have shown a decline in spite of CM) but not all. Subsequent studies will be designed to assess the degree to which this is the case by including an equivalent referent; ideally, one that has not experienced CM or, in the absence of that, one that experienced a different kind of CM so that a valid "comparative effectiveness" study can be conducted. IMPLICATIONS FOR CM PRACTICE: the "dose" of CM to its cases was in synch with an independent assessment of risk of the cases. This implies that case managers were directing their resources to those in need. However, case managers and CM processes are a limited resource and it is of interest for management to allocate those CM resources in the most efficient way possible. Methods of assessment based on individual experiences of case managers can be improved with structured, population-based assessment. These population-based tools, according to the principles of epidemiology, will be used to better allocate CM resources for optimized impact on patient populations in the future.

Loss of confidence in diabetes management.

UNLABELLED: Using current treatment approaches, many patients with type 2 diabetes do not achieve glycemic goals--and do experience macrovascular complications that contribute to morbidity and mortality. It's time to consider other options. IMPLICATIONS: Aggressive therapeutic interventions aimed at insulin resistance and cell dysfunction may alter outcomes. Managed care organizations may need to modify the way they look at diabetes and should consider changing their focus from drug costs to wellness. Value-based insurance design may provide opportunities to optimize diabetes management, resulting in improved outcomes for patients and economic benefits for managed care organizations.

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

Outcomes research priorities in chronic care: a private purchaser perspective.

Private purchasers would benefit from outcomes research in chronic care that could inform their purchasing activities, including benefit design decisions. This article presents 1 purchaser's perspective on 10 areas of research of interest to the purchasing community.

Determining the value of disease management programs.

BACKGROUND: Increasing prevalence, rising costs, and persisting deficiencies in quality of care for chronic diseases pose economic and policy challenges to providers and purchasers. Disease management (DM) programs may address these challenges, but neither purchasers nor providers can assess their value. The potpourri of current quality indicators provides limited insight into the actual clinical benefit achieved. A conference sponsored by the Agency for Healthcare Research and Quality (AHRQ) and held in October 2002 explored new approaches to measuring and reporting the value of DM for diabetes mellitus. RESULTS: Quantifying the value of DM requires measuring clinical benefit and net impact on health care costs for the entire population with diabetes. If quality is measured with indicators that are clearly linked to outcomes, clinical benefit can be estimated. Natural history models combine the expected benefits of improvements in multiple indicators to yield a single, composite measure, the quality-adjusted life-year. Such metrics could fairly express, in terms of survival and complications prevention, relatively disparate DM programs' benefits. Measuring and comparing health care costs requires data validation and appropriate case-mix adjustment. Comparing value across programs may provide more accurate assessments of performance, enhance quality improvement efforts within systems, and contribute generalizable knowledge on the utility of DM approaches. CONCLUSIONS: Conference attendees recommended pilot projects to further explore use of natural history models for measuring and reporting the value of DM.

Central challenges facing the national clinical research enterprise.

Medical scientists and public health policy makers are increasingly concerned that the scientific discoveries of the past generation are failing to be translated efficiently into tangible human benefit. This concern has generated several initiatives, including the Clinical Research Roundtable at the Institute of Medicine, which first convened in June 2000. Representatives from a diverse group of stakeholders in the nation's clinical research enterprise have collaborated to address the issues it faces. The context of clinical research is increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants. These factors have contributed to 2 major obstacles, or translational blocks: impeding the translation of basic science discoveries into clinical studies and of clinical studies into medical practice and health decision making in systems of care. Considering data from across the entire health care system, it has become clear that these 2 translational blocks can be removed only by the collaborative efforts of multiple system stakeholders. The goal of this article is to articulate the 4 central challenges facing clinical research at present--public participation, information systems, workforce training, and funding; to make recommendations about how they might be addressed by particular stakeholders; and to invite a broader, participatory dialogue with a view to improving the overall performance of the US clinical research enterprise.

Physicians as violence prevention activists--a qualitative study.

Few studies have examined the challenges facing physician activists: health care providers who engage in unpaid, non-clinical work to effect change in social issues pertaining to public health. We conducted focus groups with 19 health care providers active in violence prevention; data were analyzed using qualitative methods. Five themes emerged: (1) personal experience had generated participants' activism; (2) physicians believed they were uniquely qualified as violence prevention activists; (3) violence prevention inside the health care setting often overshadowed outside activism; (4) they feared being overwhelmed by demands of activism; and (5) they felt isolated and valued networking, especially locally, to relieve isolation. Findings illustrate the complex demands of violence prevention work on today's busy physicians.

Physicians' response to victims of domestic violence: toward a model of care.

Even though current domestic violence guidelines, such as those published by the AMA in 1992, attempt to relieve physicians of the "full burden of intervention," they continue to call upon physicians to play a large role in identifying, intervening in, and following up on case of partner abuse. In this paper, we define a limited domestic violence role for physicians which furthers the direction recommended by the AMA and which complements exemplary programs. We propose simplifying and limiting physicians' tasks to Asking patients about abuse; providing Validating messages, acknowledging that battering is wrong and confirming patient worth; Documenting presenting signs, symptoms, and disclosures; and Referring victims to domestic violence specialists (AVDR). By drawing on the literature and our own experience, we show how focusing the physician's role on these four taks is consistent with exemplary programs and expands on ideas put forth by experts for addressing domestic violence in health care settings; reduces barriers for physician interventions with victims; offers a realistic approach for physicians, reducing unrealistic educational demands; and complements managed care trends in contemporary health care.

Screening for colorectal cancer: the business case.

Colorectal cancer screening is advocated by expert groups based on strong evidence of effectiveness, yet only approximately 1 in 3 Americans are screened. For a screening program to be effective, it is necessary for providers to offer and patients to accept screening, insurers to pay for screening, and provider groups to have monitoring and reminder systems and the expertise and facilities to perform the tests well. Whether and when such screening programs become successful depends on the priorities of healthcare decision makers as much as on the efforts of individual physicians and patients. There are strong arguments for decision makers giving colorectal cancer screening programs high priority: it saves as many lives as other services now in common use; it is a good use of scarce resources, costing less than $20,000 per year of life saved; and members of insurance programs increasingly expect screening benefits and programs, and failure to offer them might lead to member dissatisfaction and malpractice claims. Screening is costly, however, taking into account the cost of screening, follow-up tests, and treatments, and the costs occur many years before the benefits. Programs that are promoted to members but not fully implemented could create disappointment and backlash. Also, this screening can cause medical complications. Nevertheless, successful programs have been developed, proving that they are feasible in today's cost-conscious environment. We believe that colorectal cancer screening programs are integral to any organization purporting to provide high-quality care. Organizations without such programs should give them high priority for implementation.