One huge can of worms.

One huge can of worms.

It’s well known that the hottest trend in diabetes devices is the development of interconnected devices and diabetes management systems. As Diabetic Investor has noted the technology for these devices already exists as evidenced by the growing number of studies looking into how or if these systems influence patient outcomes.  The general theory is that given the complexities of diabetes management patient outcomes should improve when they can share their information with their “diabetes coach”.

This use of technology to improve patient outcomes is nothing new, what’s new is the increasing use of mobile apps, social communities and web sites that are devoted exclusively for patients with diabetes. Two studies published in the most recent issue of the Archives of Internal Medicine point to some issues that lie ahead as we proceed down this path. The first is entitled; “Encounter Frequency and Serum Glucose Level, Blood Pressure, and Cholesterol Level Control in Patients With Diabetes Mellitus” by Fritha Morrison, MPH; Maria Shubina, ScD and Alexander Turchin, MD, MS – which concludes “Primary care provider encounters every 2 weeks are associated with fastest achievement of hemoglobin A1c, BP, and LDL-C targets for patients with diabetes mellitus.”

The authors state further; “In this large retrospective study, we found a strong association between encounter frequency and hemoglobin A1c, BP, and LDL-C control in patients with DM. This relationship was confirmed in individual and combined analyses of time to normalization, rate of measure decrease, and rate of target achievement. A strong dose-response relationship between encounter frequency and the outcomes was evident in all the associations we analyzed.

Current guidelines provide little guidance for how frequently patients with DM should be seen by their physicians, apart from the recommendation for hemoglobin A1c measurement every 3 months.14 The present findings provide evidence that for many patients with elevated hemoglobin A1c, BP, or LDL-C, more frequent patient-provider encounters were associated with a shorter time to treatment target, and control was fastest at 2-week intervals. Encounters every 2 weeks may, therefore, be appropriate for the most severely uncontrolled patients or under a different treatment care model.”

This particular study is very important as it’s a well-known fact that 80% of patients with diabetes are treated by a primary care physician.  However, as important as this study is, it ignores the real world implications of its conclusion. While it would be nice to believe that patients with diabetes would see their physician every two weeks this is impractical in the real world plus it’s also very expensive. Plus the results of this study are somewhat limited as pointed out by Allan Goroll, MD, MACP in his invited commentary. Dr. Goroll states; “Before concluding that a physician visit every 2 weeks should be the standard of care for patients with type 2 DM who have not reached target levels of glycemic, BP, and lipid control, we need to examine some of the limitations of the present study.7 First, the study was retrospective. As Morrison et al7 point out, a randomized prospective study is needed to more definitively establish optimal encounter frequency. Second, little information is available about the nature of the encounters, making it impossible to know what about the visit contributes most to changing patient behavior, a key determinant of successful outcomes in these conditions. Visit quality might be as important as visit frequency. Results of a recent study8 in primary care practice found a modest relation between visit duration and outcomes; providing counseling and screening increased duration of visit, but taking time to ensure medication compliance did not, yet it improved outcomes. Third, the study examined only physician encounters (either face-to-face or another type of encounter sufficient to generate a note in the EMR) and predates the widespread implementation of the medical home, where a host of additional patient “touches” are made possible (eg, e-mails, patient electronic portal, group visits, electronic reminders, and house calls) by a range of primary care medical home team members (nurse/nurse practitioner, care manager, community health worker, and pharmacist).9 Emerging data on the effectiveness of these contributions by other team members are encouraging1011 and hold promise for reducing physician burden while improving outcomes.”

To Diabetic Investor the bigger issue here is exactly what role the patients’ physician will play in this interconnected world. As Dr. Goroll points out the study only examined physician encounters and did not examine the role played by electronic encounters.  The stark reality is electronic encounters are more cost effective than in person office visits and as Dr. Goroll notes study data indicates they are equally effective at helping patients achieve better overall outcomes. The key question then becomes will primary care physicians embrace these interconnected systems or will they view them as economic threat to their practice. It does not take an advanced degree to understand the fewer office visits means less income for the physician and fewer opportunities for billable events like an A1C or cholesterol test.

The second published study entitled “Variations in Structure and Content of Online Social Networks for Patients With Diabetes” by William H. Shrank, MD, MSHS; Niteesh K. Choudhry, MD, PhD; Kellie Swanton, BA; Sachin Jain, MD, MBA; Jeremy A. Greene, MD, PhD; Bari Harlam, PhD and  Kavita P. Patel, MD, MPH – may give physicians reason for concern. In this study the authors note; “With the exponential growth of Facebook and other social networking sites, patients are increasingly seeking information and emotional support online, from other patients.12 Recent qualitative studies highlight the great potential that online social networks represent as a source of information and encouragement in chronic disease management.35 However, recent research has also identified potential pitfalls in these unregulated sites.3, 6 More than 25% of posts on Facebook sites for diabetic individuals were promotional in nature, largely directing patients to learn about products not approved by the Food and Drug Administration, and substantial efforts to gather data from Web site participants were noted.3 These findings underscore the need to guarantee the authenticity of participants and to ensure that online social networks are safe locations for patients to share information.

We know little about how commonly used sites validate the authenticity of participants’ claimed identities or how they provide oversight over the content posted by participants. In addition, little is known about the structure of communication, the sources of funding, and the presence or use of advertising on these sites. Accordingly, we conducted a survey of online social networking sites to explore characteristics of these communities and to better inform physicians and patients about the choices available to them.”

The authors conclusion; “Online social networks may play an increasing role in health promotion, as primary care physicians are asked to see increasing numbers of patients, limiting time for telephone consultations to answer questions related to chronic disease management, and as a Web-savvy population ages and develops more chronic diseases. Our evaluation of the commonly used online social networks focused on diabetes highlights their popularity and wide variability. Existing sites differ in their approach toward communication structure, authenticity and quality oversight, expert participation, and advertising or sources of funding. These metrics may be important to patients when selecting a community and may be of interest to health care providers who ultimately may advise patients about their particular needs. We hope additional research will further explore patient and health care provider perceptions about these metrics to build an evidence base to encourage social network development that will best promote patient health.”

Although this study did not examine the many mobile apps also targeted at patients with diabetes, their conclusion applies here as well. The simple fact is when it comes to the internet or mobile diabetes apps, there are no set of standards. The reality is when it comes to the internet or mobile apps the patient really does not know if the information their receiving is valid. The harsh reality is any idiot can put up a web site, social community, blog or mobile app. This fact has not gone unnoticed by the FDA as evidenced by their draft guidance for mobile health apps.

While Diabetic Investor is not a big fan of government regulation and we’re not optimistic that the FDA can develop pragmatic guidelines, we do see a need for a set of standards. While many web sites are certified by the Health On the Net Foundation (HON), this certification is a good start but in all honesty the certification has become commonplace and does not carry the weight or value it once did. Nor does the HON certification apply to the many mobile apps available.

Having reviewed the FDA’s draft guidance and speaking with several experts in the diabetes device world, Diabetic Investor sees a one huge can of worms and no easy answers. To see how complex this area could become take a look at the many companies who are developing glucose monitors that communicate with a mobile device or mobile app, the most notable being the iBGStar from Sanofi-Aventis. While the iBGStar does not need the iPhone to be attached to the device to function, there are other companies who are developing systems that must be attached to the iPhone or mobile device. Unlike the iBGStar which shows test results on the nugget, the device which attaches to the iPhone, the only way these other systems work is by being attached to the mobile device. Simply put they cannot perform their primary function without being attached to the mobile device. Diabetic Investor sees this as key distinction between the iBGStar and its many competitors, here’s why-

Let’s say you have an insulin using patient using one of these devices, this is pretty good bet given that insulin using patients are the primary target of everyone in glucose monitoring. The first question has is what happens when the mobile device is not available, out of power or receiving an actual phone call (we realize this is rare occurrence but humor Diabetic Investor). This is not an issue for the iBGStar but could be a huge issue for devices that require the iPhone for power and displaying test results.

Next and perhaps more problematic is what does the patient do with this information. It should surprise no one that almost every mobile diabetes app reviewed by Diabetic Investor offered a bolus calculator function. As we have noted in the past as available as this tool is to insulin using patients they do require a high amount of patient interaction. Even if the patient enters all this information correctly, by no means a given, what happens if the app malfunctions? Although the app does not control the actual delivery and administration of the insulin it is provided a “recommended dose”. Diabetic Investor can see the day coming when a patient administers insulin based on the apps recommendation, experiences a severe hypoglycemic event and then sues not just the app developer but the manufacturer of the phone.

We can only imagine the nightmare this type of situation would create for a company like Apple. The last thing Apple or any mobile device company wants is to see their devices regulated by the FDA. And what happens to the many apps already available should the FDA ultimately decide that mobile apps need to go through the regulatory process? The same can said for the many web sites, blogs and social communities devoted to patients with diabetes, will they need to be approved by the FDA? Or will it be enough for these sites to state implicitly that they are not offering medical advice?

Before we go any further Diabetic Investor should note there are several excellent sites and mobile apps for patients with diabetes; sites and apps that have a real and positive impact. And as we have stated in the past we do see a role for these new interconnected systems, when used properly they can help the patient achieve better outcomes. We further believe that systems such as these can be a tremendous help to the patients physician and will not detract but enhance the patient/physician relationship.

That being said, we do believe there is a need for reasonable standards. And while it pains Diabetic Investor to state this, we do believe the FDA needs to be involved in some way. The fact is diabetes sites and apps are different based on how patients use the information provided by these sites and apps. With no standards patients really have no idea if the information they are seeing is accurate, vetted in any way or even up to date. Unfortunately Diabetic Investor has seen too many sites making outrageous claims or even offering a cure for diabetes.

The real issue here is can we find a balance between protecting the patient without overly burdening the many reputable companies who are providing a valuable service for patients with diabetes. This is one huge can of worms.